RQM - Review2
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The goal of this page is to document the power of the Approval/Review options in RQM.

There are several configuration options available to configure a complex approval process.

  1. Authorization to save approvals
  2. (Auto)Locking artifacts
  3. Pre-Conditions
  4. Automatic Transfer to Approval
  5. E-signature
  6. History

Without any configuration, anybody can set a artifact from draft to in review in to approved.

In a safety critical development a tight control is needed, in agile developement less restrictive demands are a must. The challenge is to get the sweet spot for each of these kind of projects.

Save Review

It's possble to restrict a saving of an review to certain roles.

Saving a Formal Review is bound to an authority.

Lock

It's possible to lock an artifact. This E-signature is in line with the FDA-CRF 21 Part 11.

The basic E-signature of RQM when locking an artifact.

(Auto)Lock

It's possible to lock an artifact. This results in automatic locking of the artifact when a certain state is set.

Test Artifacts > Auto-Lock

Autolock setting.

We set the lock when the Under Review is set. When comming into Draft or as Approved the lock is removed.
This autolock does NOT ask for credentials. It is visible in the History.

Pre-Condition for Approval - An Approval

When a test plan/test case is set into the approve state, at least one person needs to approve the artifact.

Artifact must have an approval

Automatic Transfer to Approval

When an approval is executed the granting of the approval should 'trigger' the approval state of the artifact.

Test Artifacts > Approval Trackings

Adding E-Signature to Review

More information can be found at:

RQM 404 What's new
Requiring E-signature for the review process
Link2 Approval Tracking om automatisch naar approved te gaan bij Approval van user.

History

You can't configure it, but all changes to an artifact is logged in the history of the artifact.

Other reviews:

  1. RRC Review
  2. RQM Review
  3. RQM Review2