The Challenge of Compliance and Validation

Each phase of life science companies' product life cycle has associated regulations overning technology that must be clearly interpreted.

U.S. and European life science regulatory bodies have instituted regulations, collectively known as the GxPs (Good x Practices), which have been enacted to govern the development, testing, and manufacturing of drugs, medical devices, and biologics. Life sciences companies must comply with these regulations if they are involved with any of the aforementioned activities.

The GxPs are broken down into:

• Good Laboratory Practices (GLPs) : Regulations that apply to the non-clinical studies in the evaluation of a new drug, medical device, or biologic product.
• Good Clinical Practices (GCPs) : Regulations that apply to the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
• Good Manufacturing Practices (cGMPs) : Regulations that apply to the manufacture, testing, and distribution of a new drug, medical device, or biologic for human or veterinary use.

To establish documented evidence that a system meets these standards, and that it will continue to do so over time, requires systems validation. In Addition, there are the U.S. FDA 21 CFR Part 11 and European Annex 11 procedures for technical requirements for systems utilizing electronic records and signatures.