Batch Trend Analysis
Batch-to-batch performance, yield and critical attribute trending.
Batch Trend Analysis tracks yield, cycle time and critical quality attributes across every batch of a product, surfacing drift and variation that would otherwise only be noticed once it triggers a deviation.
What Batch Trend Analysis delivers
A controlled path from start to closure
- 1Collect Batch Data
- 2Normalise
- 3Trend
- 4Detect Drift
- 5Investigate
- 6Report
Why teams move to Batch Trend Analysis
Detect process drift months before it causes a deviation
Give process owners visibility beyond individual batch release
Support proactive process improvement rather than reactive fixes
Reduce time spent manually charting batch data in spreadsheets
Feed objective trend evidence into the annual review conclusion
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.