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Five-Day GxP Change Assessment
Planning a Veeva, eQMS, eTMF, CTMS, LMS, or other regulated-system change?
CliniGene evaluates the proposed change and provides a documented validation recommendation.
The Assessment Includes
- Change description review
- GxP-impact assessment
- Patient, product, process, and data risks
- Electronic records and signatures considerations
- Affected procedures and documents
- Recommended validation deliverables
- Proposed verification scenarios
- Initial effort estimate
- Fixed-fee execution proposal
What We Need From You
- Proposed change request
- Business requirements
- Available configuration information
- Applicable procedures
- Vendor documentation or release notes
- Relevant screenshots or process maps
What You Receive
A concise, review-ready assessment that Quality, Business, and Technology stakeholders can use to determine the appropriate implementation and validation path.