OOS & OOT Trends
Out-of-specification and out-of-trend results with investigation status.
OOS & OOT Trends consolidates laboratory results that fell out of specification or out of trend during the review period, tracking investigation status and outcome alongside the underlying analytical data.
What OOS & OOT Trends delivers
A controlled path from start to closure
- 1Aggregate Results
- 2Classify OOS / OOT
- 3Track Investigation
- 4Determine Outcome
- 5Trend
- 6Report
Why teams move to OOS & OOT Trends
Give reviewers a consolidated view of laboratory excursions
Distinguish assignable causes from genuine process variation
Reduce manual compilation of laboratory investigation status
Support earlier detection of analytical or process drift
Provide traceable evidence linking results to affected batches
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.