Improve the efficiency of your Regulatory Team with prepackaged templates.

If your Regulatory personnel have experience in leading an FDA Validation project that included the back-end ERP software, then you can leverage your internal resources by having them take the lead in the process. To support their efforts and to maximize their efficiency, the Copley FDA Validation Templates provide guidance to streamline their workload. Our templates cover these elements of the Validation process:

Value Provided

     • Validation Plan (VP) Template
     • Traceability Matrix (TM) Template
     • Installation/Operational/Performance Qualification (IOPQ) Protocol Template
     • IOPQ Summary Report Template
     • Validation Summary Report (VSR) Template
     • Computerized Information Systems Validation
     • Procedure/Work Instructions Templates

FDA Validation Support

     • FDA Validation Support Services
     • FDA Validation OPQ Scripts & Test Plans