Change History
Reason for change captured and comparable across revisions.
Change History captures the stated reason for every document revision and makes each version comparable, giving reviewers and inspectors clear context for why a document changed.
What Change History delivers
A controlled path from start to closure
- 1Propose Change
- 2State Reason
- 3Compare Versions
- 4Review Rationale
- 5Approve
Why teams move to Change History
Give reviewers clear context for every revision
Support regulatory submissions with documented rationale
Trend document change reasons across the portfolio
Link document changes back to their originating change control
Reduce ambiguity during investigations into document history
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.