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.

If it is unclear as to which areas of your business might need FDA validation, the FDA provides the following guidance:

Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use. This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.

Additional clarification on whether your business needs FDA validation, may be found on the U.S. Food & Drug Administration website.

Copley supports our FDA regulated clients by providing validation plan preparation, traceability matrix definition, operation and performance test cases, technical installation verification, IOPQ protocol and summary reports, as well as a validation summary report.

For companies who require regulatory compliance, business process validation - inclusive of computer software - is a critical component of maintaining full compliancy. While validation ensures that your use of the software is substantiated and documented, the validation process can consume your company’s valuable resources. When implementing a new ERP solution to improve your company’s business processes, it is essential that your FDA validation and your ERP Go-Live are on the same concurrent timeline.

Copley’s consultants, with deep knowledge of FDA regulations, provides the appropriate level of support to guide you through the process, either taking the lead in your validation project or supporting your efforts while your regulatory team provides the project stewardship.