Validation
Validation
Alternate Systems is more than just an accredited calibration and testing laboratory. Alternate Systems can complete a 21 CFR Part 11 validation including DQ/IQ/OQ/PQ and risk analysis for a complete independent verification and validation package. We can deploy hundreds of data loggers to environmentally map almost any space to document GMP compliance in FDA-regulated environments and help you understand and reduce your risk.
- Risk Assessment
- Protocol Development
- Test Design
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Environmental Mapping