Audit Trail
Immutable 21 CFR Part 11 audit trail on every asset transaction.
Audit Trail records every create, edit, approval and status change made against an asset, work order or calibration record in an immutable, time-stamped log aligned with 21 CFR Part 11 and EU GMP Annex 11.
What Audit Trail delivers
A controlled path from start to closure
- 1Capture Event
- 2Timestamp & Attribute
- 3Store Immutably
- 4Search / Export
- 5Periodic Review
Why teams move to Audit Trail
Evidence full traceability on every asset transaction
Remove the risk of untracked, manual data changes
Answer inspector questions with a searchable trail, not memory
Support periodic computerised system reviews with ready evidence
Retain accountability even after staff turnover
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.