Minimize risk with blended Validation and ERP deployment services.
For companies who require regulatory compliance, business process validation inclusive of computer software is a critical component of maintaining fully compliancy. While validation ensures that your use of the software is substantiated and documented, the validation process consumes your valuable resources. However, not executing a concurrent validation and software deployment projects concurrently can expose you to the risk of an FDA audit noting you to be in non-compliance.
Copley personnel provide the appropriate level of support to guide you through this process, either taking the lead in your Validation Project or supporting your efforts while your Regulatory Team provides the project stewardship. Our services cover:
• Validation plan preparation
• Traceability matrix definition
• Operation and performance test cases
• Technical installation verification
• IOPQ protocol
• IOPQ summary report
• Validation summary report