Establish an Audit-ready Digital PSMF with improvised Process Efficiency and Regulatory Compliance
The Pharmacovigilance System Master File (PSMF) is a key regulatory requirement for pharmaceutical companies to demonstrate compliance with pharmacovigilance regulations. The PSMF serves as a comprehensive document that describes the pharmacovigilance system in place for a particular drug or product, providing regulatory authorities with a clear understanding of how a company manages safety information related to the product. It is commonly requested and assessed by National Competent Authorities or by the Agency during regulatory inspections and audits.
As this is a living document, Manufacturing Authorization Holders (MAH) are expected to regularly update all Core elements of PSMF along with all the information in the Annexures (A to I). Companies must ensure that they have effective processes in place to address the challenges associated with PSMF preparation and management, to ensure that the PSMF is effective in managing safety information related to their products.
Common Challenges faced by MAH Representatives
- Complexity: The PSMF is a complex document that requires input from various departments within a company, including clinical research, regulatory affairs, quality assurance, and safety. Coordinating and integrating this input can be challenging, particularly if the company operates in multiple countries with different regulatory requirements.
- Timeliness: The PSMF must be updated regularly to reflect changes in the pharmacovigilance system. Keeping the PSMF up to date can be challenging, particularly if the company is managing multiple products and dealing with multiple regulatory authorities.
- Data Management: The PSMF must contain a significant amount of data, including adverse event reports, signal detection and evaluation, risk management plans, and benefit-risk assessments. Ensuring that this data is accurate, complete, and up to date can be challenging, particularly if the company is using multiple databases or data sources.
- Resource Allocation: Developing and maintaining a PSMF requires significant resources, including personnel, time, and money. Companies must allocate these resources effectively to ensure that the PSMF meets regulatory requirements and is effective in managing safety information.
- Regulatory Compliance: The PSMF must comply with regulatory requirements in each country where the product is marketed. This can be challenging, particularly if the company is operating in multiple countries with different regulatory requirements.
- Operational Insights: Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections
Introducing Compier ePSMF
Compier PSMF enables pharma companies to digitalize and automate the complete PSMF life cycle management helping them to get audit-ready and stay compliant with global regulations. It automatically updates data points in the annexures obtained from other Compier modules and through source system integrations. The default ePSMF templates enables clients to quickly adopt this capability in their current process.
Solution Features & Benefits
Modular and Templatized
All sections and annexures of a PSMF can be managed as individual PSMF components in Compier. Each component has its own lifecycle with version control.
Digital Authoring & Version Control
Compier facilitates authoring of each PSMF component directly in the application with version control and template history.
Collaborative Review and Approval
Initiate real-time collaborative PSMF components review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures.
Annexure Management
Compier facilitates automated inclusion of annexures from multiple source systems (safety database, Document Management System, QMS, etc.)
PSMF Workflow Management
Define and configure workflows from scheduling, and authoring to submission by setup user access and permission controls as to who can view, edit, review, approve PSMF components. Stay informed on workflow tasks assignments, workflow tasks, and related activity updates.
Electronic PSMF Distribution
With Compier, PV Teams can generate and maintain an accurate PSMF throughout the pharmacovigilance lifecycle in the mandated regulatory format. The PSMF PDF Reports can be instantly generated and presented during audits and inspections.
Correspondence and Collaboration
Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between internal PV Teams.
Process Alerts & Notifications
Proactively address all operational issues and stay informed on the progress of all PSMF related activities through configurable system alerts and notifications.
Digital PSMF Oversight
Perform comprehensive oversight of all PSMF updates across sections and annexures as per the schedule using Compier's built-in reports and dashboards.
Business Advantages
- Global Compliance Adherence for PSMF Management
- Optimize Operational Efficiency through digitalization
- Establish Audit Readiness with PSMF Updates and Reports
- Auto PSMF Updates
Solution FAQs
We offer the Compier PSMF solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PSMF along with the required system integrations.
Compier PSMF is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.
Our subject matter experts will deliver a hands-on Compier PSMF application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations.
The Compier PSMF solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity.
The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions.
