Risk Management
Risk registers, scoring matrices and mitigation tracking across processes.
Risk Management provides a live register of quality risks across products, processes, suppliers and systems, with configurable scoring, mitigation actions and periodic monitoring and review.
What Risk Management delivers
A controlled path from start to closure
- 1Identify
- 2Assess
- 3Score
- 4Mitigate
- 5Monitor
- 6Review
Why teams move to Risk Management
Maintain one enterprise view of quality risk
Apply consistent scoring across sites
Prioritise resources against residual risk
Evidence risk-based decision making
Feed risk context into change control and audits
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.