Systems and roles¶
A system is one computerised system you validate (a LIMS, an ERP module, a chromatography data system). Creating a system creates its lifecycle documents, ready to write.
Create a system¶
Choose New system on the dashboard and enter its name, version, description and intended use. The GAMP software category is recorded in the System Risk Assessment. You become a member with every role, so remove the roles you should not hold before anything is signed (an author cannot approve their own work anyway; see Independence).
Optionally set the Test code repository if the system's automated tests live in git. See Automated runs.
System roles¶
Roles are assigned per system, on the system's Members page. One person can hold several roles on a system.
| Role | Does |
|---|---|
| Author | Writes documents, requirements and test cases, edits the requirement library, submits documents for review. |
| Reviewer | Reviews submitted documents and signs the review. |
| Approver (QA) | Approves reviewed documents and closes deviations. |
| Tester | Executes tests, records automated runs, raises deviations. |
Organization owners and admins can see every system in their organization and manage its members, but they still need a system role to sign.
Members¶
Add a member by choosing a user of your organization and a role. Removing a member does not change anything they already signed.
Audit trail¶
Each system has an Audit trail page listing every change to its records: who, when, the reason for the change, and a field-level diff. Every edit asks for a reason for change.