Change Control Review
Changes implemented in the period and their impact on the product.
Change Control Review summarises every product, process and equipment change implemented during the reporting period, assessing collectively whether cumulative changes affected product performance or specifications.
What Change Control Review delivers
A controlled path from start to closure
- 1Aggregate Changes
- 2Classify
- 3Assess Cumulative Impact
- 4Verify Effectiveness
- 5Summarise
- 6Report
Why teams move to Change Control Review
Reveal cumulative impact that individual change assessments miss
Reduce manual compilation of the year's change history
Give reviewers confidence that changes have not shifted performance
Provide a single change record traceable across the review period
Support faster regulatory response on implemented changes
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.