Ennov PV Safety Documents
Maintain Continuous Inspection-Readiness
- Manage case reports, RMPs, PSMF, and agreements in one place
- Maintain an inspection-ready PSMF with clear ownership and traceability
- Track agreements and obligations with workflows, tasks, and reminders
- Reduce compliance risk with standardized governance
- Collaborate securely across teams and partners
- Meet FDA 21 CFR Part 11 with audit trails and electronic signatures
Ennov PV Safety Documents is a comprehensive, centralized solution for managing pharmacovigilance documentation, including Pharmacovigilance System Master File (PSMF) management solution and all supporting compliance records.
It enables organizations to author, maintain, govern, and distribute PV documentation within a fully compliant, traceable, and controlled environment. The solution is designed to ensure continuous inspection readiness while providing complete traceability, lifecycle control, and advanced search capabilities across all Safety documentation related content and processes all within a unified environment.
Centralized Global
and Local PSMF Management
The Ennov PV Documents serves as a single authoritative repository for all global and affiliate PSMFs, supporting both centralized governance and local regulatory requirements. Organizations can:
- Maintain a global PSMF aligned with corporate standards
- Manage country-specific or affiliate PSMFs
- Synchronize global and local content
- Track regional deviations, local annexes and country-specific requirements
- Maintain standardized templates and structures
- Generate regulator-ready PSMF outputs automatically
Comprehensive PV Document Management
Beyond PSMF, the platform manages the full spectrum of pharmacovigilance documentation, including:
- Safety, periodic, and aggregate reports (e.g., PSUR, PBRER, DSUR)
- Literature monitoring outputs and safety data
- Risk management and signal documentation
- SOPs, work instructions, and governance documents
- Training materials and compliance records
- Audit and inspection documentation
- Vendor oversight and regulatory correspondence
- Safety communication and notification distribution
Regulatory Report Management and Distribution
The system centrally manages regulatory reports generated from validated case data, ensuring controlled storage, traceability, and compliant distribution:
- Supports reports such as ICSRs, CIOMS, SUSARs, periodic and aggregate outputs
- Automates archiving, versioning, and distribution workflows with clock tracking to IRBs and ECs
- Uses configurable business rules to ensure consistent dissemination to health authorities, partners, and stakeholders
- Ensures alignment with regional and global regulatory requirements
- Report management and distribution are based on configurable business rules that ensure consistency and compliance with regional regulations.
Full Traceability and Version Control
The core strength of Ennov PV Safety Documents is complete lifecycle traceability. Every change made to the PSMF environment is recorded and auditable, including:
- Full version control with locked, auditable document states
- Detailed history of revisions, annex updates, and change requests
- Configurable workflow approvals and electronic signatures
- Complete audit trails capturing all user actions and system events
- Tracking of data synchronization and content updates across global and local PSMFs
- Continuous readiness aligned with global regulatory expectations (GVP, FDA, EMA, etc.)
- Ennov PV Documents maintains a detailed audit trail with timestamped activity logs and archived prior versions to support inspections and demonstrate compliance with global regulations.
Business Benefits
By implementing Ennov PV Documents, pharmaceutical organizations can achieve:
Ennov PV Documents transforms the Pharmacovigilance System Master File from a static document into a dynamic, structured, and continuously governed compliance system that supports proactive pharmacovigilance oversight, operational efficiency, and global regulatory compliance.
- Reduced compliance and inspection risk
- Improved operational transparency
- Faster retrieval of inspection evidence
- Reduced manual administrative effort
- Better global affiliate coordination
- Improved governance and accountability
- Increased efficiency in maintaining PSMFs
- Enhanced confidence in audit readiness
Core Capabilities
- Optimized case capture interface
- Search engine style querying
- Configurable data section and field layouts
- Searchable vocabulary lists
- Rapid coding tool
- Drag-and-drop palette for frequently used data
- Speech to text for narratives
- Social style case management tools
Key Features
- Data entry interface is configured to mirror call flow
- Dramatically speeds up data entry
- Modern and intuitive layout
- Optimized for call center operations
- Reduces training overhead and accelerates on-boarding
- Seamless connectivity to PV-Works
- 100% web-based
- 21 CFR Part 11 compliant
How a Global Pharma and Animal Health Leader Migrated 1M+ Safety Records to the Cloud
When infrastructure modernization meets zero tolerance for downtime
From Vendor Frustration to Compliance Confidence
How a Human Pharmacovigilance Services Provider Found a Long-Term Platform and Partner
An End-To-End Solution for Collecting, Reporting and Analyzing Human and Vet PV Data
The Ennov Pharmacovigilance solution keep the collection, management, assessment, and reporting of human or veterinary adverse events in one unified database while also providing advanced signal detection and PV data analysis tools.
Why Choose Ennov
Over 500,000 users trust Ennov
Over 500,000 users trust Ennov
- Over 25 years of experience providing software solutions for Life Sciences and 450+ Life Science customers, with many more in other industries.
- Modern architecture and interface 100% web-based. Highly scalable. User-centric design.
- Our commitment to your success Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Providing you freedom of choice
- Available as cloud-based or on-premises deployment, you can switch between deployment options at any time.
- System configuration and management require no IT skills, making you fully autonomous
- Improved security and optimized performance. Data can be hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
ISO 9001 & 27001 Certified
How can we help you?
Fill out the form and we'll be in touch.