Audit Trail
Immutable, time-stamped record of every training transaction.
Audit Trail captures every assignment, completion, assessment, certification and administrative change as a computer-generated, time-stamped record that cannot be edited or disabled, meeting Part 11 and Annex 11 expectations.
What Audit Trail delivers
A controlled path from start to closure
- 1Capture Event
- 2Timestamp
- 3Bind Identity
- 4Store Immutably
- 5Retrieve on Demand
Why teams move to Audit Trail
Provide inspectors a complete, tamper-evident training history
Remove the risk of back-dated or altered training records
Support root-cause investigations with a reliable event history
Meet 21 CFR Part 11 and EU GMP Annex 11 audit trail expectations
Reduce time spent reconstructing training history from memory
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.