Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight
Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.
Common Challenges faced by MAH Representatives
Introducing Compier Agreements
Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance.
Solution Features & Benefits
- Global Compliance Adherence on PV Agreements
- Achieve Complete Partner Compliance Oversight
- Optimize Operational Efficiency
- Audit Readiness with PSMF Updates and Reports
- Integration with Exchange and Reconciliation
- Auto ePSMF Updates
- Agreements Oversight Dashboards
We offer the Compier PV Agreements 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 PV Agreements system along with the required system integrations.
Compier Agreements 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 PV Agreements 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 PV Agreements 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.