Stability Studies
Protocols, storage conditions, pull-point scheduling and trend reporting.
Stability Studies manages long-term, accelerated and intermediate protocols across storage conditions, automatically generating pull points and samples while trending results toward shelf-life determination.
What Stability Studies delivers
A controlled path from start to closure
- 1Design Protocol
- 2Assign Chambers
- 3Generate Pull Points
- 4Test
- 5Trend
- 6Shelf-Life Evaluation
- 7Report
Why teams move to Stability Studies
Never miss a scheduled stability pull point
Cut manual effort in generating stability samples
Trend shelf-life data across conditions in one view
Support regulatory filings with audit-ready protocols
Track ongoing stability commitments to completion
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.