Integrated Deviation Management for full operational certainty.
In the event of a detected deviation, such as a defective filter, the system immediately informs responsible personnel via automated alarm functions. This enables an immediate response to critical events.
Comprehensive Area Coverage
In addition, the system now supports measurement methods such as Clean-Up tests (according to GMP Annex 1), air exchange rates, overflow tests, and physical environment measurements. Moqlero now seamlessly covers all relevant areas of the controlled environment (other parameters like particles, recovery, laminar flow measurements etc. were already integrated).
Digital CAPA Process (Corrective And Preventive Action)
The system digitalizes the entire workflow from detection to remediation and ensuring compliance:
- Evaluation & Correction: Responsible personnel are obliged to evaluate the situation immediately and can document and initiate the necessary corrective actions directly in the system.
- Electronic Release: Using the electronic signature function, the responsible person can authorize and release an immediate retest directly after completing corrective work.
- Seamless Traceability: All activities – deviation detection, evaluation, and retest authorization – are electronically documented and audit-proof linked to the corresponding order and recorded in the audit trail.
Extension of Existing Systems
Moqlero addresses specialized cleanroom workflows and thus complements your existing system landscape. Instead of replacing existing customer systems, it acts as a powerful extension that creates operational certainty in critical situations.