In the regulated world of pharmaceutical manufacturing and life sciences, ensuring that computer systems are fit for use and compliant with regulations (like FDA 21 CFR Part 11 and EU Annex 11) is non-negotiable. The GAMP 5 (Good Automated Manufacturing Practice) guideline, published by ISPE, provides a risk-based approach to validating these systems.
Need help with your next validation project? Contact our compliance team for a risk assessment. gamp 5 hardware categories