Product Quality Review
The full annual review assembled per product, strength and market.
Product Quality Review consolidates every quality data stream for a single product into one structured annual review, covering batch performance, laboratory results, deviations, complaints and stability across the full reporting period.
What Product Quality Review delivers
A controlled path from start to closure
- 1Select Product & Period
- 2Collect Data
- 3Consolidate
- 4Review
- 5Assess
- 6Approve
Why teams move to Product Quality Review
Replace months of manual compilation with a structured, live review
Give QA one place to assess an entire product's annual performance
Ensure every review section is traceable to its source data
Support side-by-side comparison across review cycles
Reduce the risk of a missed or late annual review
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.