Standards Management
Reference and working standards with potency, expiry and usage logs.
Standards Management controls reference and working standards from receipt through potency assignment, expiry monitoring and usage, ensuring only qualified standards are used in testing.
What Standards Management delivers
A controlled path from start to closure
- 1Receive
- 2Qualify
- 3Assign Potency
- 4Store
- 5Use
- 6Requalify / Retire
Why teams move to Standards Management
Ensure only current, qualified standards are used
Prevent expired standard use through automated alerts
Maintain full traceability from reference to working standard
Simplify standard requalification scheduling
Provide inspectors a complete standards usage history
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.