CAPA Integration
Native link into the OPS IQ CAPA workflow and effectiveness checks.
CAPA Integration connects manufacturing deviations and non-conformances directly into the OPS IQ CAPA workflow, so corrective and preventive actions carry the original batch, equipment and material context through to effectiveness verification.
What CAPA Integration delivers
A controlled path from start to closure
- 1Raise CAPA
- 2Assign Owner
- 3Implement Action
- 4Verify Effectiveness
- 5Close
- 6Report
Why teams move to CAPA Integration
Avoid duplicate data entry between eBMR and CAPA
Keep manufacturing context attached to every CAPA
Verify CAPA effectiveness against subsequent batch runs
Reduce recurrence of manufacturing-related deviations
Report CAPA performance specific to production events
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.