CAPA Summary
CAPA raised, closed, overdue and effectiveness within the period.
CAPA Summary rolls up every corrective and preventive action associated with a product during the review period, showing what was raised, closed, overdue and confirmed effective, so the review reflects real remediation status.
What CAPA Summary delivers
A controlled path from start to closure
- 1Aggregate CAPAs
- 2Classify Status
- 3Calculate Closure Time
- 4Check Effectiveness
- 5Summarise
- 6Report
Why teams move to CAPA Summary
Show reviewers the true status of remediation, not just counts
Surface recurring CAPAs that indicate an unresolved root cause
Reduce manual tracking of CAPA status across systems
Provide inspectors direct evidence of CAPA closure discipline
Support management review with objective effectiveness data
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.