What Validation Management covers
Validation Management is the paperless validation of computerized systems, facilities and equipment, processes, cleaning, and analytical methods. A validation answers whether an asset, at a point in time, has been challenged against its requirements and whether the evidence and approvals are complete.
Formal deliverable documents follow the QualityDocs document lifecycle. Objects, workflows, electronic signatures, and audit come from the platform.
How assets are layered
| Object | Role in validation |
|---|---|
| Entity family | Groups identical or equivalent assets that share mandatory requirements |
| Validation entity | The asset being validated |
| Entity version | That asset at one point in time. Requirements, activities, and deliverables hang off the version |
| Requirement | A requirement or specification used to challenge the asset |
| Validation activity | One validation effort: scope, dates, participants, and its deliverables |
| Deliverable | A placeholder in the activity. The body lives on a document or a test record |
Start with the entity, then the entity version for this point in time. Hang requirements and activities on the version that is being challenged, not on a generic asset name.
Testing
A test protocol contains one or more test scripts. After pre-approval, a script is handed to the executor. A script is a set of test steps. A step can carry additional prompts the executor fills in.
An exception found during execution is recorded as a validation discrepancy, then investigated with a root cause and a correction. The traceability matrix records how requirements, entity versions, activities, deliverables, scripts, and steps relate, so you can see which execution covers which requirement.
Approval
Script pre-approval, sending an activity for approval, and any other step that needs a chosen participant run as a workflow. Participants are selected first. Approve and reject are verdicts on the task. While the record is in approval, do not change the state from the lifecycle state menu.
Before an activity can complete, the system checks that the expected deliverables and script conclusions are in place. If the check fails, the activity stays where it is and does not complete.
Where to start
| Goal | Article |
|---|---|
| Entities, versions, activities | Validation entities and activities |
| Scripts, execution, discrepancies | Test script execution |
| Formal deliverable documents | QualityDocs |
Use Validation navigation for entities, activities, and scripts; My Tasks for execution and approval.
FAQ
| Symptom | What to check |
|---|---|
| Executor = reviewer blocked | Separation of duties; sharing and task assignees |
| Cannot complete activity | Deliverable and script rollup; open discrepancies |
| Requirements not covered | Maintain RTM links to steps |