OOS Management
Structured out-of-specification investigations with phase-wise closure.
OOS Management triggers a structured, phase-wise investigation the moment a result fails specification, capturing hypothesis, retest authorisation, laboratory and manufacturing investigation, and final disposition.
What OOS Management delivers
A controlled path from start to closure
- 1Trigger
- 2Phase 1 Investigation
- 3Hypothesis
- 4Retest / Resample
- 5Phase 2 Investigation
- 6Disposition
- 7Closure
Why teams move to OOS Management
Investigate failures consistently every time
Shorten OOS closure time with guided phases
Prevent unauthorized retesting outside procedure
Trend recurring OOS causes by method or analyst
Present a defensible, complete file at inspection
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.