CAPA Management
Structured corrective and preventive actions with effectiveness verification.
CAPA Management gives quality teams a single, workflow-driven place to initiate, investigate and close corrective and preventive actions, with every action owner, due date and effectiveness check recorded against the originating event.
What CAPA Management delivers
A controlled path from start to closure
- 1CAPA Initiation
- 2Investigation
- 3Root Cause
- 4Corrective / Preventive Action
- 5Implementation
- 6Effectiveness Check
- 7Closure
Why teams move to CAPA Management
Close CAPAs faster with automated routing and reminders
Reduce repeat events through structured root cause analysis
Make overdue actions and escalations visible in real time
Evidence effectiveness checks for inspectors
Link CAPAs to deviations, complaints, audits and non-conformances
Trend CAPA performance across sites and products
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.