Incident Logs
Operational incidents recorded and escalated into quality events.
Incident Logs capture operational incidents as they happen on the shop floor, classifying severity and escalating anything with a potential quality or safety impact directly into the formal deviation or investigation process.
What Incident Logs delivers
A controlled path from start to closure
- 1Capture Incident
- 2Classify Severity
- 3Notify
- 4Escalate to Quality
- 5Track Resolution
- 6Close
Why teams move to Incident Logs
Ensure shop-floor incidents reach quality without delay
Prevent minor events being logged verbally and forgotten
Provide a searchable incident history by area and shift
Cut the time between occurrence and formal investigation
Trend recurring operational issues before they escalate
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.