Deviation Management
Deviations raised automatically from the execution record.
Deviation Management within eBMR raises deviations automatically the moment an out-of-limit entry or missed step occurs during batch execution, carrying full batch context into the investigation from the start.
What Deviation Management delivers
A controlled path from start to closure
- 1Auto-Detect
- 2Classify
- 3Investigate
- 4Assess Impact
- 5CAPA
- 6Approve
- 7Close
Why teams move to Deviation Management
Capture deviations with full batch context automatically
Reduce time between event occurrence and investigation start
Assess batch impact before the release decision is made
Trend deviations by line, shift and product
Link manufacturing deviations directly to CAPA
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.