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
- Inefficiencies in identifying suitable partners and vendors without a centralized partner database
- Lack of historical performance measures to qualify partners and vendors for future engagements
- Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates
- Delays in completing the agreement review and sign-off with manual sharing of documents
- Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence
- Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections
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
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.
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 and 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.
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.
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.
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.