CMMSComputerised Maintenance Management System

A CMMS is the digital system of record for everything maintenance does: which assets exist, what condition they're in, what parts are on the shelf, what work is scheduled, what work is in progress, what work has been completed and what it cost. It replaces — and improves on — the paper logbook, the spreadsheet PM schedule and the parts-bin reorder cards that older plants still rely on. SMRP defines it as the digital backbone of the maintenance and reliability function.

• Equipment / asset register — every regulated piece of equipment with an identifier, location, criticality, model, serial, validation history, manuals, drawings.
• Preventive-maintenance (PM) scheduler — calendar-, runtime- or condition-based PMs with task lists, parts, durations, skill requirements.
• Calibration register — instruments, calibration interval, due date, as-found / as-left history, traceability to standards (NIST, NPL).
• Work-order management — request → triage → planning → scheduling → execution → close-out with labour hours, parts consumed, downtime.
• Spare-parts inventory — stock levels, reorder points, supplier, lead time, cost, criticality tied to asset.
• Procurement — purchase requisitions for parts and external services.
• Downtime and reliability — failure codes, MTBF, MTTR, downtime feeding OEE / ISO 22400 KPIs.
• Reporting and dashboards — open WOs, overdue PMs, calibration-due-soon, top failure codes, cost per asset.

A consumer-grade CMMS will not satisfy FDA, EMA or MDSAP inspectors. A regulated-grade CMMS must add:

• 21 CFR Part 11 / EU Annex 11 compliant — audit trail (who/what/when/why with before/after), electronic signatures bound to records, role-based access, retention controls.
• Validated — IQ/OQ/PQ executed against a URS, with traceability matrix, and CSV / CSA risk-based testing for changes.
• Equipment-status interlock with execution — an asset that is overdue PM, overdue calibration, under deviation, or under maintenance-block cannot be used for GMP production. The kiosk / MES queries CMMS in real time and blocks WO start.
• Calibration evidence trail — every calibration linked to traceable standards, with as-found / as-left readings and impact assessment if as-found is out of tolerance (cross-references §211.68, USP <41>, ISO/IEC 17025).
• Change control — equipment changes flow through a controlled change record that triggers re-qualification where required.
• Document control — equipment SOPs, IQ/OQ protocols and reports, vendor manuals all version-controlled and tied to the asset.

• Calendar-based — every N days/weeks/months. Simplest, often over- or under-services.
• Runtime-based — every N hours of operation, every N cycles. Aligns service with actual use.
• Condition-based (CBM) — driven by sensor data (vibration, temperature, lube oil analysis, current draw). Service when condition indicators cross thresholds.
• Predictive (PdM) — machine-learning on sensor + history to forecast failure. The most efficient where the data is rich; requires the upfront data foundation a modern CMMS can provide.
• Reliability-Centred Maintenance (RCM) — failure-mode-driven strategy selection (run-to-fail, scheduled-discard, scheduled-restoration, condition-based, redesign).

Regulated plants typically operate a hybrid: calendar PMs for low-criticality and statutory items (pressure vessel, lifting equipment), runtime PMs for high-utilisation equipment, condition-based for high-cost rotating equipment. The CMMS supports all four.

Of all CMMS data, calibration is the most regulator-scrutinised. The CMMS must hold: instrument tag, manufacturer / model / serial, location, current calibration certificate (electronic copy), next-due date, calibration-interval rationale, traceability to recognised standards, as-found readings, as-left readings, calibration-vendor accreditation (ISO/IEC 17025 preferred), impact-assessment workflow when as-found is out of tolerance.

Out-of-tolerance as-found readings trigger a deviation and a backwards-scoping investigation: which products were tested or processed on this instrument since the last successful calibration? Are those products at risk? The investigation outcome may force product hold, recall scoping, or batch-record disposition review. The CMMS supports the investigation by holding the complete asset usage history.

CMMS downtime data — start time, end time, cause code, action taken, parts used — flows directly into ISO 22400 KPIs (MTBF, MTTR, Availability) and into the OEE Availability term. Regulated plants increasingly run live OEE dashboards on the shop floor; the CMMS is the single source of truth for the unplanned-downtime denominator.

Many regulated plants have an incumbent CMMS (Maximo, Fiix, UpKeep, eMaint, Hippo) they will not retire. The right pattern is to leave the incumbent as the maintenance system of record and integrate at the equipment-status boundary: the MES / kiosk queries CMMS for the live status of each asset (PM-due, calibration-due, under-maintenance, under-deviation) and blocks production accordingly. Equipment changes, completed PMs and completed calibrations flow back from CMMS to the MES so the qualified status updates in real time.

• CMMS not validated — usability rolled out across regulated equipment without CSV / CSA.
• No equipment-status interlock with execution — overdue PMs silently allowed to run.
• Calibration intervals chosen by tradition not by data — never reviewed against drift history.
• Calibration certificates stored in vendor email rather than attached to the asset record.
• Downtime data captured at the supervisor level ("line was down 4 hr") instead of at the failure level ("bearing failure on conveyor 3 at 14:22").
• Spare-parts inventory not linked to assets — stockouts of critical parts not visible until the breakdown.
• Change control bypassed — a like-for-like part swap is fine; a different brand of bearing on a critical asset is a change.