Why life science companies are ditching Point Solutions for Unified Platforms
Picture this: Your Quality team discovers a manufacturing deviation requiring immediate global notifications. But instead of a streamlined response, disconnected systems force manual work: exporting
Why life science companies are ditching Point Solutions for Unified Platforms
Picture this: Your Quality team discovers a manufacturing deviation requiring immediate global notifications. But instead of a streamlined response, disconnected systems force manual work: exporting
Best Practices for Implementing RIM and QMS Systems in 2025
Life sciences organizations face mounting pressure to accelerate regulatory processes while maintaining rigorous quality standards. Whether ensuring compliance, expanding globally, or managing complex product portfolios,
IDMP & xEVMPD Compliance: How to Manage Structured Data for EMA and Global Regulatory Success
1. Introduction: Why IDMP and xEVMPD Matter More Than Ever If you work in regulatory affairs or operations in life sciences, you’ve likely encountered the
Publishing: Common Issues and How to Improve Timelines
Regulatory teams know the feeling: your documentation is complete, the submission plan is sent, and yet, you’re still waiting days for your submission to be
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer
The New Wave of QMS [8/8]: Reflections & Looking Ahead
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on
The New Wave of QMS [7/8]: Cybersecurity Measures
In today’s digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools
The New Wave of QMS [6/8]: Flexibility & Adaptability
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in
The New Wave of QMS [5/8]: User-Centric Interface
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while
The New Wave of QMS [4/8]: Data-Driven Decisions
In today’s digitized world, data is often termed as the “new oil.” The Life Sciences industry, rich in complex processes and critical operations, generates vast
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that
The New Wave of QMS [3/8]: Scalability
In the evolving landscape of the Life Sciences industry, growth and diversification are constants. From expanding into new markets, and developing innovative products, to integrating
The New Wave of QMS [2/8]: Comprehensive Integration
In an era marked by rapid technological advancements and increasingly interconnected business ecosystems, the call for seamless integration in Quality Management Systems (QMS) has become
Strategic Safety Data Management for Cosmetic Compliance
The cosmetics industry is constantly changing, making safety data management a unique challenge. To adhere to global regulations, cosmetic companies need a versatile Cosmetovigilance (CV) system that
The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety.
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs
The RAP Up: Trends from 2023 RAPS Convergence
Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41%
The Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
As Life Science professionals, we often find ourselves at the crossroads of scientific innovation, compliance, and strategic business initiatives. Yet, how often do we pause
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and
Best Practices: Cross-Referencing in eCTD
Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is
Empowering Emerging Pharma Organizations through DLSP Strategy
The life sciences industry is rapidly evolving, and emerging pharmaceutical companies are at the forefront of this disruption. Companies leverage streamlined operations, nimble teams, and
Top 5 Trends in Life Sciences in 2023: Driving the Future of Innovation
The Life Sciences industry is undergoing a period of rapid transformation. As we progress through 2023, several critical trends have emerged, each presenting unique opportunities
Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
For medical device companies, accurate and consistent data is critical for regulatory compliance and patient safety. Master Data Management (MDM) is an essential process that
Empower Your Quality Management Journey with Gartner Market Guide Insights
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner’s latest Market Guide
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
Common Reasons for eCTD Rejection by the FDA and How to Prevent Them
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of
Enhancing Technology Strategy for Efficient Clinical Development
As clinical trial complexity increases, life sciences companies must have a technology strategy that supports research, development, and commercial business units. A recent Gartner report,
Integrated Software: Revolutionizing Customer Complaints and CAPA Management
The pharmaceutical industry plays a critical role in ensuring the health and well-being of people all over the world. With this important responsibility, it is
Maximizing Value in Healthcare: How CIOs Can Drive Ongoing Strategic Cost Optimization
Healthcare and Life Science CIOs are facing mounting pressures to manage costs, optimize resources, and deliver value in an environment characterized by competing priorities and
Finding the Right Fit: Key Considerations for Selecting an Integrated Quality Management System
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision.
Unlocking the Future of Healthcare: Insights from the 2023 Gartner Report on Digital Transformation
The life sciences industry is at the brink of a digital transformation, with economic pressures and disruptive technology and innovation challenging traditional business models. A
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate,
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of
Optimize Your eTMF Strategy
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
IDMP & xEVMPD Compliance: How to Manage Structured Data for EMA and Global Regulatory Success
1. Introduction: Why IDMP and xEVMPD Matter More Than Ever If you work in regulatory affairs or operations in life sciences, you’ve likely encountered the
Publishing: Common Issues and How to Improve Timelines
Regulatory teams know the feeling: your documentation is complete, the submission plan is sent, and yet, you’re still waiting days for your submission to be
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that
The RAP Up: Trends from 2023 RAPS Convergence
Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41%
The Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
As Life Science professionals, we often find ourselves at the crossroads of scientific innovation, compliance, and strategic business initiatives. Yet, how often do we pause
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and
Best Practices: Cross-Referencing in eCTD
Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is
Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
For medical device companies, accurate and consistent data is critical for regulatory compliance and patient safety. Master Data Management (MDM) is an essential process that
Common Reasons for eCTD Rejection by the FDA and How to Prevent Them
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will
Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and
Why life science companies are ditching Point Solutions for Unified Platforms
Picture this: Your Quality team discovers a manufacturing deviation requiring immediate global notifications. But instead of a streamlined response, disconnected systems force manual work: exporting
Best Practices for Implementing RIM and QMS Systems in 2025
Life sciences organizations face mounting pressure to accelerate regulatory processes while maintaining rigorous quality standards. Whether ensuring compliance, expanding globally, or managing complex product portfolios,
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s
The New Wave of QMS [8/8]: Reflections & Looking Ahead
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on
The New Wave of QMS [7/8]: Cybersecurity Measures
In today’s digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools
The New Wave of QMS [6/8]: Flexibility & Adaptability
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in
The New Wave of QMS [5/8]: User-Centric Interface
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of
The New Wave of QMS [4/8]: Data-Driven Decisions
In today’s digitized world, data is often termed as the “new oil.” The Life Sciences industry, rich in complex processes and critical operations, generates vast
The New Wave of QMS [3/8]: Scalability
In the evolving landscape of the Life Sciences industry, growth and diversification are constants. From expanding into new markets, and developing innovative products, to integrating
The New Wave of QMS [2/8]: Comprehensive Integration
In an era marked by rapid technological advancements and increasingly interconnected business ecosystems, the call for seamless integration in Quality Management Systems (QMS) has become
The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety.
Empower Your Quality Management Journey with Gartner Market Guide Insights
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner’s latest Market Guide
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of
Integrated Software: Revolutionizing Customer Complaints and CAPA Management
The pharmaceutical industry plays a critical role in ensuring the health and well-being of people all over the world. With this important responsibility, it is
Finding the Right Fit: Key Considerations for Selecting an Integrated Quality Management System
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision.
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018
Optimize Your eTMF Strategy
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
Risk-Based Monitoring Improved
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical
Top 5 eTMF Features | etmf systems
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate,
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary
Ennov PV – An Auto-Testing Revolution
[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with
EudraVigilance Update, GVP Module IX, and the Impact on Signal Detection
With the release of the new Eudravigilance system on 22nd November 2017, the European Medicines Agency (EMA) have introduced greater access to adverse event data
Our Journey with Scrum
[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while
Strategic Safety Data Management for Cosmetic Compliance
The cosmetics industry is constantly changing, making safety data management a unique challenge. To adhere to global regulations, cosmetic companies need a versatile Cosmetovigilance (CV) system that
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs
Why life science companies are ditching Point Solutions for Unified Platforms
Picture this: Your Quality team discovers a manufacturing deviation requiring immediate global notifications. But instead of a streamlined response, disconnected systems force manual work: exporting
Best Practices for Implementing RIM and QMS Systems in 2025
Life sciences organizations face mounting pressure to accelerate regulatory processes while maintaining rigorous quality standards. Whether ensuring compliance, expanding globally, or managing complex product portfolios,
IDMP & xEVMPD Compliance: How to Manage Structured Data for EMA and Global Regulatory Success
1. Introduction: Why IDMP and xEVMPD Matter More Than Ever If you work in regulatory affairs or operations in life sciences, you’ve likely encountered the
Publishing: Common Issues and How to Improve Timelines
Regulatory teams know the feeling: your documentation is complete, the submission plan is sent, and yet, you’re still waiting days for your submission to be
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer
The New Wave of QMS [8/8]: Reflections & Looking Ahead
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on
The New Wave of QMS [7/8]: Cybersecurity Measures
In today’s digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools
The New Wave of QMS [6/8]: Flexibility & Adaptability
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in
The New Wave of QMS [5/8]: User-Centric Interface
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while
The New Wave of QMS [4/8]: Data-Driven Decisions
In today’s digitized world, data is often termed as the “new oil.” The Life Sciences industry, rich in complex processes and critical operations, generates vast
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that
The New Wave of QMS [3/8]: Scalability
In the evolving landscape of the Life Sciences industry, growth and diversification are constants. From expanding into new markets, and developing innovative products, to integrating
The New Wave of QMS [2/8]: Comprehensive Integration
In an era marked by rapid technological advancements and increasingly interconnected business ecosystems, the call for seamless integration in Quality Management Systems (QMS) has become
Strategic Safety Data Management for Cosmetic Compliance
The cosmetics industry is constantly changing, making safety data management a unique challenge. To adhere to global regulations, cosmetic companies need a versatile Cosmetovigilance (CV) system that
The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety.
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs
The RAP Up: Trends from 2023 RAPS Convergence
Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41%
The Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
As Life Science professionals, we often find ourselves at the crossroads of scientific innovation, compliance, and strategic business initiatives. Yet, how often do we pause
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and
Best Practices: Cross-Referencing in eCTD
Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is
Empowering Emerging Pharma Organizations through DLSP Strategy
The life sciences industry is rapidly evolving, and emerging pharmaceutical companies are at the forefront of this disruption. Companies leverage streamlined operations, nimble teams, and
Top 5 Trends in Life Sciences in 2023: Driving the Future of Innovation
The Life Sciences industry is undergoing a period of rapid transformation. As we progress through 2023, several critical trends have emerged, each presenting unique opportunities
Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
For medical device companies, accurate and consistent data is critical for regulatory compliance and patient safety. Master Data Management (MDM) is an essential process that
Empower Your Quality Management Journey with Gartner Market Guide Insights
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner’s latest Market Guide
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
Common Reasons for eCTD Rejection by the FDA and How to Prevent Them
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of
Enhancing Technology Strategy for Efficient Clinical Development
As clinical trial complexity increases, life sciences companies must have a technology strategy that supports research, development, and commercial business units. A recent Gartner report,
Integrated Software: Revolutionizing Customer Complaints and CAPA Management
The pharmaceutical industry plays a critical role in ensuring the health and well-being of people all over the world. With this important responsibility, it is
Maximizing Value in Healthcare: How CIOs Can Drive Ongoing Strategic Cost Optimization
Healthcare and Life Science CIOs are facing mounting pressures to manage costs, optimize resources, and deliver value in an environment characterized by competing priorities and
Finding the Right Fit: Key Considerations for Selecting an Integrated Quality Management System
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision.
Unlocking the Future of Healthcare: Insights from the 2023 Gartner Report on Digital Transformation
The life sciences industry is at the brink of a digital transformation, with economic pressures and disruptive technology and innovation challenging traditional business models. A
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate,
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of
Optimize Your eTMF Strategy
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
IDMP & xEVMPD Compliance: How to Manage Structured Data for EMA and Global Regulatory Success
1. Introduction: Why IDMP and xEVMPD Matter More Than Ever If you work in regulatory affairs or operations in life sciences, you’ve likely encountered the
Publishing: Common Issues and How to Improve Timelines
Regulatory teams know the feeling: your documentation is complete, the submission plan is sent, and yet, you’re still waiting days for your submission to be
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that
The RAP Up: Trends from 2023 RAPS Convergence
Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41%
The Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
As Life Science professionals, we often find ourselves at the crossroads of scientific innovation, compliance, and strategic business initiatives. Yet, how often do we pause
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and
Best Practices: Cross-Referencing in eCTD
Today, the eCTD format remains the only globally approved and ICH-recommended standard. While it has been in use for more than 15 years, it is
Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
For medical device companies, accurate and consistent data is critical for regulatory compliance and patient safety. Master Data Management (MDM) is an essential process that
Common Reasons for eCTD Rejection by the FDA and How to Prevent Them
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will
Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and
Why life science companies are ditching Point Solutions for Unified Platforms
Picture this: Your Quality team discovers a manufacturing deviation requiring immediate global notifications. But instead of a streamlined response, disconnected systems force manual work: exporting
Best Practices for Implementing RIM and QMS Systems in 2025
Life sciences organizations face mounting pressure to accelerate regulatory processes while maintaining rigorous quality standards. Whether ensuring compliance, expanding globally, or managing complex product portfolios,
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s
The New Wave of QMS [8/8]: Reflections & Looking Ahead
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on
The New Wave of QMS [7/8]: Cybersecurity Measures
In today’s digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools
The New Wave of QMS [6/8]: Flexibility & Adaptability
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in
The New Wave of QMS [5/8]: User-Centric Interface
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of
The New Wave of QMS [4/8]: Data-Driven Decisions
In today’s digitized world, data is often termed as the “new oil.” The Life Sciences industry, rich in complex processes and critical operations, generates vast
The New Wave of QMS [3/8]: Scalability
In the evolving landscape of the Life Sciences industry, growth and diversification are constants. From expanding into new markets, and developing innovative products, to integrating
The New Wave of QMS [2/8]: Comprehensive Integration
In an era marked by rapid technological advancements and increasingly interconnected business ecosystems, the call for seamless integration in Quality Management Systems (QMS) has become
The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety.
Empower Your Quality Management Journey with Gartner Market Guide Insights
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner’s latest Market Guide
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of
Integrated Software: Revolutionizing Customer Complaints and CAPA Management
The pharmaceutical industry plays a critical role in ensuring the health and well-being of people all over the world. With this important responsibility, it is
Finding the Right Fit: Key Considerations for Selecting an Integrated Quality Management System
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision.
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate,
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary
Ennov PV – An Auto-Testing Revolution
[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with
EudraVigilance Update, GVP Module IX, and the Impact on Signal Detection
With the release of the new Eudravigilance system on 22nd November 2017, the European Medicines Agency (EMA) have introduced greater access to adverse event data
Our Journey with Scrum
[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018
Optimize Your eTMF Strategy
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the
Risk-Based Monitoring Improved
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical
Top 5 eTMF Features | etmf systems
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while
Strategic Safety Data Management for Cosmetic Compliance
The cosmetics industry is constantly changing, making safety data management a unique challenge. To adhere to global regulations, cosmetic companies need a versatile Cosmetovigilance (CV) system that
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs
Authors
Sean Carpenter
Regulatory Expert
Sean has over 20 years of experience in delivering Regulatory and Pharmaceutical Record Management solutions for a wide array of large and small Life Science companies.
He has experience as a consultant, product owner, business analyst and director of IT for software and services companies, from small start-ups to global multi-national organisations.
Josh Keliher
Solutions Expert
Josh Keliher has more than 20 years of experience as an expert in Life Science Regulatory, Quality and Clinical (eTMF, CTMS) IT solutions. He has worked for renowned Software Vendors and is currently a senior presales consultant at Ennov.
Alice Merrill
Regulatory Information Management Expert
Alice has worked in Regulatory Operations for 8 years, with expertise in Regulatory Information Management, process design and documentation and user support. As a RIM consultant, Alice brings her experience working in large pharmaceutical companies to supporting clients using Ennov InSight/RIM, developing best practices and ensuring that clients are up to date on all the latest regulatory developments.
Diarmuid Waide
Regulatory Information Management Expert
Diarmuid has 6 years of experience with Regulatory Publishing and RIM, managing submissions and submitting to agencies worldwide. Having published for large and small pharmaceutical companies he has a unique insight into both the working practices and needs each require. As a Senior Consultant with Ennov, Diarmuid will liase with clients regularly informing them of upcoming changes in the regulatory landscape and provide guidance on how to best use Ennov InSight/RIM to optimise their experience.
Nic Pillinger
Pharmacovigilance Expert
Nic has 18 years of experience with pharmacovigilance systems, in the UK and the USA, managing the product range and working with customers to implement and improve operations.
As the director of pharmacovigilance products, he ensures that Ennov’s pharmacovigilance offer meets the highest international standards.
Chet Shemanski
Marketing VP
Chet Shemanski is a proven business and information technology professional with extensive experience serving the healthcare and global life sciences industries.
He has specific expertise in software product commercialization including product management, product marketing, solution strategy, and alliance management.
Chet is a subject matter expert in eClinical and eRegulatory technologies, the author of industry journal articles and a speaker at industry conferences.
Steve Clark
Regulatory Expert
Steve has a Master’s Degree in Immunology from the University of Essex, UK and over 25 years of experience serving in various senior Regulatory Affairs and Regulatory Operations roles for companies including Gilead, Amgen, Merck, Baxter and Parexel.
He is responsible for the implementation of Ennov Regulatory systems and assisting the development of the Ennov Regulatory product suite.
