Audit Trail records an immutable, time-stamped history of every entry, correction and approval made against the batch record, providing the traceability regulators expect without relying on individual discipline.
What Audit Trail delivers
A controlled path from start to closure
- 1Capture Event
- 2Record Metadata
- 3Store Immutably
- 4Review
- 5Export
- 6Retain
Why teams move to Audit Trail
Provide complete traceability without manual reconstruction
Detect unusual change patterns before they become findings
Support investigations with an exportable, searchable trail
Enforce data integrity independent of individual discipline
Meet retention requirements for electronic records
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.