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.

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Solution Features & Benefits

Centralized Partner Data Management

Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place. 

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Templatized Digital PVA Authoring & Versioning

Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions.

Collaborative PVA Review and Approval

Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures.

SLA Definition & Tracking

Configure multiple Service Level Agreement measures for each agreement to track partner's activity timelines and overall compliance adherence


Integration with Exchange Tracker

Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker.

File Transfer

Automated Safety Data Exchange Reconciliation

Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards.

Correspondence and Collaboration

Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners.

Process Alerts & Notifications

Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications. 

Mail Notification

Process Insights & Partner Oversight

Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight.


Business Advantages

  • 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

Solution FAQs

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.

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