Paradigm Shift: The World's First Agile Validation in GMP.
Traditional re-qualifications are rigid, cost-intensive, and often force days of production downtime. Moqlero breaks this outdated "Waterfall" model and establishes a revolutionary, agile validation strategy, first successfully audited at Roche.
Modular "Atomic" Qualification
Instead of treating the entire cleanroom as a monolithic block, Moqlero decomposes qualification into atomic, logical units (Test Sets). This allows surgically precise re-validation of changes:
Scenario: Filter Exchange
If a single HEPA filter is replaced, Moqlero automatically generates a dynamic test plan checking only the affected spot (Leak Test) and immediate vicinity (Recovery Test, Particle Measurement).
- No Redundancy:Unaffected zones require no re-qualification. The system provides "Evidence of Non-Impact" that adjacent areas remained stable.
- Compliance Boost:This granularity meets EU GMP Annex 1 requirements for a Continuous Contamination Control Strategy (CCS) far better than annual "Big Bang" tests.
The Result: Up to 70% reduction in downtime while simultaneously increasing compliance density.