Non-Conformance
Non-conformance logging, disposition and linkage to CAPA.
Non-Conformance manages material, product and process non-conformances from detection through classification, investigation and disposition, with CAPA linkage, approval and trending.
What Non-Conformance delivers
A controlled path from start to closure
- 1Report
- 2Classify
- 3Investigate
- 4Disposition
- 5CAPA
- 6Approval
- 7Closure
Why teams move to Non-Conformance
Control non-conforming material with clear disposition records
Reduce rework and scrap through cause analysis
Keep quarantine and release decisions traceable
Link non-conformances to suppliers and batches
Trend recurring conformance issues
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.