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