Validation Turbo: GAMP 5 Category 4 (COTS) Certification.
Validation is often the biggest bottleneck in software implementations. Moqlero removes this hurdle: Our system has been officially classified by independent auditors as "Commercial Off-The-Shelf" (COTS) software of GAMP 5 Category 4.
Why Category 4 is Crucial
Unlike custom software (Category 5), Moqlero is a configurable standard product. This means for you:
- No Code Tests: You do not need to perform white-box tests or code reviews. Functional correctness is already guaranteed by our Quality Management.
- Focus on Configuration: Your validation (IQ/OQ/PQ) focuses purely on correct configuration and mapping of your business processes.
Supplier Audit Package
We provide a complete "Supplier Audit Package" containing our full documentation. Benefit from pre-built functional specifications, test specifications, and manuals specifically tailored to Moqlero and the validation of software in the pharmaceutical industry.
Massive Time Savings
This COTS approach significantly shortens and simplifies the implementation phase – from months to weeks – with full compliance to FDA 21 CFR Part 11 reports and EU GMP incl. EU GMP Annex 1.