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 development standards, test protocols, and ISO 9001 certificate.
- Ready-to-Use Templates:Benefit from pre-built URS, Risk Analysis (FMEA), and Test Plan templates specifically tailored to Moqlero.
Massive Time Savings
This COTS approach shortens 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.