Deviation Analysis
Deviation counts, categories, recurrence and root cause patterns.
Deviation Analysis aggregates every deviation raised against a product during the review period, classifying by category, area and root cause to reveal recurrence patterns that a single-event view would miss.
What Deviation Analysis delivers
A controlled path from start to closure
- 1Aggregate Deviations
- 2Classify
- 3Detect Patterns
- 4Compare Periods
- 5Summarise
- 6Report
Why teams move to Deviation Analysis
Reveal recurring root causes hidden across individual deviations
Prioritise process improvement using pattern-based evidence
Reduce manual counting and categorisation of deviation data
Support year-on-year benchmarking of product performance
Strengthen the review's root-cause narrative with real trend data
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.