FDA Validation Templates

To support Regulatory personnel’s 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:

  • 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 Tools

Copley’s FDA Extended ERP solution ensures validation of the software’s intended use while exposing a company to their risk of FDA audit non-compliance if not properly executed. Our experience with FDA requirements and manufacturing best practices for clients has led to our development of these templates and an implementation methodology to ensure FDA compliance.

OPQ Scripts

The extensive, detailed documentation required in support of your OPQ report can be burdensome to your organization, with errors requiring significant rework. The operational and performance validation scripts, developed specifically for the Infor Cloudsuite solution, help you reduce the effort, and lessens the risk of errors by facilitating compliance with these stringent requirements.

Support & Services

Implementing an ERP solution for organizations that fall under FDA regulations must go through a validation process. The validation determines, defines, governs and documents the formal testing of Good Manufacturing Practices (GMP) and relevant activities pertaining to the definition, production and delivery of regulated products and services.


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