What is GxP compliance?
GxP is a broad term that applies to many different quality standards and regulations. Viewed through a software development lens, GxP compliance means that a system meets a specific set of regulatory protocols and best practices.
There isn’t a central governing body that oversees GxP compliance within software development. Instead, companies must adhere to specific standards set by regulatory bodies, which can vary across different regions and industries.
Some examples of these regulatory bodies include:
- U.S. Food and Drug Administration (FDA)
- Federal Communications Commission (FCC)
- International Organization for Standardization (ISO)
- European Union Medical Device Regulation (EU MDR)
- European Medicines Agency (EMA)
When a product is GxP compliant, it means the solution aligns with the various requirements set forth by specific regulatory agencies. For example, the FDA’s 21 CFR Part 11 compliance states that companies must treat electronic records and signatures the same as paper records and handwritten signatures.