Equipment Management
Equipment master, maintenance and qualification status in one register.
Equipment Management holds the equipment master and full asset lifecycle — qualification, calibration, preventive and breakdown maintenance, work orders and history — and extends into Nexgensis Enterprise Asset Management for plant-wide maintenance operations.
What Equipment Management delivers
A controlled path from start to closure
- 1Register Asset
- 2Qualify
- 3Maintain & Calibrate
- 4Work Orders
- 5History
- 6Retire
Why teams move to Equipment Management
One register for every GxP-critical asset
Keep qualification and calibration status visible before use
Reduce unplanned downtime with preventive schedules
Track work orders and breakdowns to completion
Retain complete equipment history for inspections
Built for regulated operations
21 CFR Part 11
Electronic records and electronic signature controls — unique user identity, secure e-signatures and computer-generated audit trails on every record.
EU GMP Annex 11
Computerised system controls including access management, change control, data integrity and periodic review of the system.
GAMP 5
Risk-based validation approach, with pre-executed IQ/OQ documentation supplied with every release.
ALCOA++
Records that are attributable, legible, contemporaneous, original and accurate — enforced at record level.
OPS IQ is designed to support these regulatory expectations. Compliance is achieved together with your own validated implementation, procedures and controls.
Connected to your enterprise systems
ERP / SAP
Master data, materials and batch context exchanged over open REST and event APIs.
MES
Shopfloor execution events and equipment context linked to quality records.
LIMS
Laboratory results and specification data connected to quality decisions.
Identity Providers
Enterprise SSO and role-based access through your existing identity provider.
Enterprise APIs
Open REST and event APIs for custom and legacy systems.