QA Review presents only the exceptions, deviations and out-of-limit entries in a batch record for review, replacing page-by-page paper checking with a focused, faster review process.
What QA Review delivers
A controlled path from start to closure
- 1Receive Batch
- 2Identify Exceptions
- 3Review
- 4Query / Resolve
- 5Sign Off
- 6Forward for Release
Why teams move to QA Review
Cut batch review time by focusing only on exceptions
Reduce reviewer fatigue from page-by-page paper checks
Speed up query resolution between QA and production
Track reviewer turnaround against release targets
Apply consistent review criteria across products
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.