Ennov Doc for Pharmacovigilance
Centralize your PV documentation in one compliant system
- 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
Document Management for PSMF, Agreements, and Risk Documentation
Stay inspection-ready with a single 21 CFR Part 11–compliant system of record
Teams often manage the Pharmacovigilance System Master File (PSMF), documents, and partner agreements across shared drives, email, and disconnected tools. That fragmentation leads to version confusion, slow retrieval, limited traceability, and gaps in oversight of safety obligations, increasing inspection risk and making it harder to stay audit-ready across EU and US requirements.
Ennov Doc for PV centralizes documents and the PSMF, while supporting agreement management in a structured repository built for compliance. Teams can maintain an inspection-ready PSMF, control document lifecycles, and track agreements, obligations, and related activities with clear ownership and audit trails supporting 21 CFR Part 11. The result is more consistent global documentation, secure collaboration across internal and partner teams, and fewer operational gaps when audits and inspections occur.
The 4 Key Components of Ennov Doc for PV
Submissions & Reports
Centralize all submissions and reports—aggregate, clinical, and safety—generated from your safety database and submitted to Health Authorities and other competent bodies, fully aligned with global reporting requirements.
Risk Management
Manage the complete lifecycle of global and local Risk Management documents, leveraging safety data, risk assessments, and quality metrics to support continuous and robust benefit–risk evaluation.
Agreements
Streamline the management of agreements defining roles, responsibilities, data exchange, and obligations across partners, affiliates, and third parties. Track responsibilities with advanced search, workflows, task management, and automated due-date notifications to ensure operational oversight.
Pharmacovigilance System Master File (PSMF)
Aggregate and maintain all documentation required under GVP Module II and Directive 2001/83/EC / Regulation (EC) No 726/2004 within a structured binder. Automatically generate an audit-ready PSMF that clearly documents your system structure, processes, and regulatory compliance.
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 onboarding
- Seamless connectivity to PV-Works
- 100% web-based
- 21 CFR Part 11–compliant
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 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
- 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
