The PSMF (the blueprint of your global Pharmacovigilance process) is mandatorily requested and assessed by any national competent authorities or by the Agency during regulatory inspections and audits. From time to time, It is mandatory for any MAH (Manufacturing Authorization Holder) to update all Core elements of PSMF along with all the information in the Annexures (A to I).
Today, your EU QPPV, drug safety team members, safety officers at global sites along with outsourcing team members rely on a manual collection of PSMF relevant information/ updates from various siloed data sources and team members located across the globe. The team further spend time on numerous meeting/ conference calls and share information via emails, shared folders etc. Further, the core document and annexures are managed through MS word documents and spreadsheets. This entire process of PSMF life cycle management is redundant and inefficient.
Key Solution Capabilities
- Modular and Templatized: Manage ePSMF components as modules and templates
- Digital Authoring: Author within application without any dependency on third party apps
- Collaborative Review: Review modules of ePSMF with multiple reviewers at the same time
- Automate Annexure Data: with proper integration to the source allows to data collation without any manual intervention.
- Workflow driven activities: Configurable workflow from authoring till expiry
- Access Control: Define controls to who can view, or edit ePSMF
- Version Controlled: Access latest version of ePSMF with archived older versions
- Auto Update Rules: Auto update-modules, templates and ePSMF based on rules defined
- Sharing: Share ePSMF in various formats PDF, ppt, through various channels
- Correspondence: The module has its own inbox and outbox facility to track information exchange for each record
- Alerts & Notifications: Get alerted and notified on work assignment, expiry and changes
- Insights & Analytics: Ready to use and extendable dash boards, performance indicators
- Audit-Ready: Facilitate remote audits by providing ePSMF online access to auditors from any part of the world.
Seamless Integrations with various source systems to enable 100% process automation
- Drug Safety Database
- Signal Management System
- Clinical Systems
- Quality Management System
- Training Management System
- Other modules of Compier
- Other organization wide operational data source systems
Key Advantages
- Gain process efficiency with a modern and purpose-built solution
- Improve oversight and reduce risk with alerts and notifications
- Stay current, take advantage of best practices and ready to use modular, version-controlled templates
- Seamlessly collaborate with global team members by digitally authoring core document and flexible workflow for end to end management
- Modern architecture, advanced functionalities, and ready built-in connectors for various standard third-party databases for an efficient process
- Real-time reports and dashboards provide the necessary visibility for risk mitigation and compliance
How Do we Deliver
ePSMF is a component of our Compier platform. It can be deployed on its own or in combination with other modules of the platform.
Our comprehensive technology platform, process accelerators and subject matter expertise enable you with a comprehensive solution to digitalize and automate the entire compliance associated with PSMF. Our solutions are flexible, modular and can be deployed by MAH, QPPV office and CRO companies globally or at local entities.
Request a Product Tour
Industry Insights
Best Practices for Signal Management in Pharmacovigilance
Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]
Aggregate Reporting – Significance, Classification and Challenges
Aggregate reports are the cumulative reports in the database that emphasise on evaluation of safety profile and risk-benefit analysis of a drug. Aggregate reporting is the process of compilation and submission of aggregate reports to the regulatory agencies over the period of the product’s life cycle (during pre-marketing and post-marketing phase) to provide a comprehensive [...]
Literature Screening – Process overview, challenges en-route and the scope for automation
Medical and scientific literature is a valuable source of safety information that helps in monitoring benefit-risk profiles and emerging safety issues of medicinal products. Literature screening is conducted to ascertain abstracts and articles that provide crucial information on serious and non-serious Individual Case Safety Reports (ICSR) reports and risk-benefit assessment of a drug. The scientific [...]