Products/Maintenance & Monitoring
SMM · Systems, Maintenance & Monitoring

Calibration, PM and EM — scheduled, signed, in one place.

Calibration, preventive maintenance, downtime tracking and environmental monitoring — unified with quality so every excursion is investigated and every asset stays qualified.
What you can achieve

Built by life science experts to simplify maintenance & monitoring.

“Calibration, PM and EM used to live in three systems. Now they live with quality, where they belong.”
        Engineering Lead · Biotech

Improved traceability & automation

Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.

Confident compliance

Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.

Data-driven oversight

Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.

Faster implementation

Go live in weeks — not quarters — with structured rollout, training and 24/7 support.

How teams use SMM in practice

From day one — every step controlled.

Calibration management

  • Schedule calibrations by asset and frequency
  • Capture as-found / as-left data
  • Block use when out of calibration
  • Trigger CAPAs on out-of-tolerance results

Preventive maintenance

  • Plan PM by asset, hours or cycles
  • Issue and track work orders
  • Capture parts and labour
  • Report compliance vs. plan

Environmental monitoring

  • Manage routine EM schedules
  • Capture results from sensors or manual entry
  • Trend by room, grade and organism
  • Trigger investigations on excursions

Asset & qualification status

  • Single view of every GxP asset
  • Status: qualified, due for cal, in PM, retired
  • Link to validation packs in VLM
  • Track downtime and OEE
Core capabilities

Everything SMM ships with.

Asset register

Central register of all GxP equipment and instruments.

Schedule engine

Time, usage or condition-based scheduling.

Work order workflow

Issue, execute and close work orders with e-sign.

Sensor integration

Ingest EM and utility data with audit trail.

Excursion management

Route excursions to QA for investigation.

Downtime tracking

Capture downtime reasons and report OEE.

Compliance baked in

Designed to support the standards you’re audited against.

EU GMP Annex 11Annex 1521 CFR Part 11ISO 17025USP <1058>ALCOA++

See SMM on your own data.

Bring a real scenario from your operations — we’ll show you exactly how Maintenance & Monitoring handles it.