Incident Investigation
Guided investigations with structured root cause methodologies.
Incident Investigation guides teams through consistent evidence collection, root cause analysis and risk assessment for quality, safety and operational incidents, ending in approved corrective actions and closure.
What Incident Investigation delivers
A controlled path from start to closure
- 1Report
- 2Investigate
- 3Collect Evidence
- 4Root Cause
- 5Actions
- 6Approval
- 7Closure
Why teams move to Incident Investigation
Standardize investigation quality across sites
Keep evidence attached to the record, not in email
Apply proven root cause methodologies consistently
Escalate high-risk incidents automatically
Trend incident causes for prevention
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.