OOT Management
Out-of-trend detection, evaluation and linkage to quality actions.
OOT Management applies statistical trending to results within specification, flagging drift toward a limit early so quality teams can act before a result becomes an out-of-specification event.
What OOT Management delivers
A controlled path from start to closure
- 1Detect Drift
- 2Flag
- 3Evaluate
- 4Disposition
- 5Link Quality Action
- 6Monitor
Why teams move to OOT Management
Catch drifting results before they fail specification
Reduce OOS events through earlier intervention
Distinguish statistical noise from genuine trend
Feed trend evidence into deviation and CAPA records
Give QA visibility into process drift over time
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.