Deviation Management
Event capture, classification, investigation and closure in one flow.
Deviation Management captures unplanned events at the point of occurrence, classifies them by criticality, drives a structured investigation and impact assessment, and links resulting actions to CAPA through to closure.
What Deviation Management delivers
A controlled path from start to closure
- 1Report
- 2Classify
- 3Investigate
- 4Root Cause
- 5Impact Assessment
- 6CAPA
- 7Approval
- 8Closure
Why teams move to Deviation Management
Report events immediately from the shopfloor or lab
Apply consistent classification criteria
Shorten investigation cycle time
Assess batch and product impact before release
Trend recurring deviations by area, product and cause
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.