Role-Based Access
Least-privilege access by role, department, site and document type.
Role-Based Access restricts document visibility and actions to least-privilege roles defined by department, site and document type, so users see only what their role requires.
What Role-Based Access delivers
A controlled path from start to closure
- 1Define Roles
- 2Assign Access
- 3Enforce at Runtime
- 4Review Periodically
- 5Revoke on Change
Why teams move to Role-Based Access
Ensure users see only the documents their role requires
Enforce segregation of duties automatically
Simplify access recertification with scheduled reviews
Reduce risk from stale or excessive access grants
Integrate cleanly with enterprise identity systems
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.