RBAC · Segregation of duties · Kiosk scoping
Role-based access that matches how a regulated plant works.
Set roles and choose which kiosk tiles each person can use.
Thirteen Standard GxP Roles, Properly Documented
Owner, Controller, QA Manager, Approver, Supervisor, Reviewer, Author, Purchasing, Warehouse Operator, Maintenance, Operator, Auditor and IT Admin —…
Custom Roles as Named Bundles
Create 'Night Shift Lead' or 'External Consultant' as your own named role that grants one or more standard roles plus a fixed set of kiosk tiles.
Kiosk-Tile and Stage Scoping
Operators see only the stations and stage kinds their role covers, which removes a whole class of wrong-task errors on a shared shop-floor device.
What goes wrong today4 common problems
Off-the-shelf roles never match your job titles
The plant has night shift leads, receiving clerks and external consultants. The software has admin and user. People end up over-privileged so work can continue.
Segregation of duties is a policy, not a control
If the same person can author, review and approve, the SOP saying otherwise is the only barrier — and it is the first thing an inspector tests.
Operators see screens that are not their job
A shared kiosk showing every tile invites the wrong task being started against the wrong order.
No one can explain what a role actually unlocks
Access reviews stall when the only definition of a role is a tooltip on a picker.
Everything V5 does here4 capabilities
Thirteen Standard GxP Roles, Properly Documented
Owner, Controller, QA Manager, Approver, Supervisor, Reviewer, Author, Purchasing, Warehouse Operator, Maintenance, Operator, Auditor and IT Admin — each with a stated purpose, what it unlocks, whether it can e-sign, whether it is kiosk-capable and a live member count.
Custom Roles as Named Bundles
Create 'Night Shift Lead' or 'External Consultant' as your own named role that grants one or more standard roles plus a fixed set of kiosk tiles. Members show the custom name, expanded to the standard roles beneath it.
Kiosk-Tile and Stage Scoping
Operators see only the stations and stage kinds their role covers, which removes a whole class of wrong-task errors on a shared shop-floor device.
Access reviews that answer themselves
A roles page with live member counts, click-through to filtered team lists and audited grant history turns the periodic access review into a read rather than a project.
Standards Referenced
- 21 CFR Part 11 §11.10(d), (g), (i) (access limits, authority checks, training)
- 21 CFR 211.25 (personnel qualifications)
- EU GMP Annex 11 §2, §12 (personnel, security)
- ISO 13485 §6.2 (competence and awareness)
- GAMP 5 (2nd edition) — logical security
Common questions5 answers
- What is role-based access control in a GMP system?
- RBAC grants permissions to roles rather than to individuals, so what a person can do follows the job they hold. In a GMP system it is also the mechanism that enforces segregation of duties and limits system access to authorised individuals under Part 11 §11.10(d).
- Can we rename or create our own roles?
- The thirteen standard roles are fixed because access rules depend on them, but you can create custom named roles that bundle one or more standard roles and a defined set of kiosk tiles. The member record shows both the custom name and the standard roles it expands to.
- How is segregation of duties enforced?
- Signing authority is a property of the role, and review and approval steps require different signers. The system rejects a second signature from the same user rather than relying on procedure.
- Can operators be limited to specific stations?
- Yes. Kiosk tiles and production stage kinds can be scoped per role, so a shared device shows only the work that role is meant to perform.
- What does an access review look like?
- Open the roles page, read the live member count per role, click through to the filtered team list, and export the grant history showing who received which role, when and under whose signature.