Pharma CMMS & Asset Maintenance: 21 CFR Part 11 Calibration, Breakdown Work Orders & Spare Parts Inventory

Standard industrial maintenance software lacks the regulatory controls required in pharmaceutical manufacturing: 21 CFR Part 11 electronic signatures, validated audit trails, GAMP 5 validation evidence, and direct interlocks with batch manufacturing and cleanroom logbooks.

Novaqis CMMS is engineered natively as an integral part of Novaqis ERP, purpose-built for regulated pharmaceutical and medical device manufacturing plants.

Assets (autoclaves, fluid bed processors, compression presses, WFI generation loops, HVAC AHUs) are categorized by GxP criticality: • Preventive Maintenance Plans: Time-based (monthly, quarterly, annual) or run-hour based triggers synced directly with production batch runs. • Digital Work Order Execution: Step-by-step maintenance checklists with tool calibrations, torque specifications, and lubricant traceability. • Spare Parts Reconciliation: Automatic consumption of gaskets, mechanical seals, and filters from Novaqis ERP warehouse inventory with minimum reorder alerts.

Calibration workflows enforce strict metrological standards: • Master Calibration Standard Traceability: Calibration tools (digital multimeters, temperature dry wells, pressure calibrators) must possess active NABL/NIST calibration certificates. • As-Found vs As-Left Documentation: If an instrument is found out-of-calibration (As-Found excursion), the system instantly generates a quality deviation in Novaqis QMS to assess product impact on all batches manufactured since the last valid calibration check. • Strict Return-to-Dirty Interlock: Work order completion automatically forces the equipment into 'Dirty' status in Novaqis eLog™, preventing reuse until sanitization is validated.