Equipment Qualification
DQ, IQ, OQ, PQ status and requalification triggers per equipment.
Equipment Qualification tracks the design, installation, operational and performance qualification status of every piece of GxP equipment, triggering requalification automatically when changes or time thresholds require it.
What Equipment Qualification delivers
A controlled path from start to closure
- 1Plan Qualification
- 2Execute DQ/IQ/OQ/PQ
- 3Review Results
- 4Approve
- 5Monitor for Requalification
Why teams move to Equipment Qualification
Keep qualification status visible before it becomes a release blocker
Trigger requalification automatically from change control
Produce qualification evidence packs on demand for inspectors
Reduce risk of using unqualified equipment in production
Link qualification failures directly into deviation management
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.