Click the button below to find downloadable resources to assist with your initial Qualio Validation and feature revalidation. These resources will exist in perpetuity and will only be added to with any new release, never removed.
The image above depicts the Qualio Validation Support root folder and the 3 main sub-folders:
Feature Val Packs
A folder for each Launch Train is created for the release. The Launch Train Title is the month and year it is available for viewing. It also has the month it will be released to Production, and the version number.
When validating, customers need to only reference the LATEST Launch Train/version. Past versions are retained for historical change control purposes.
Within the Launch Train folder is a Qualio System Validation (VAL-) document that consolidates all feature documents and a folder for each feature (ex: Documents, Events, Suppliers)
The Documentation and Test Evidence folder content is described in the Executing Qualio Validation article and may vary depending on the feature and the release
Support Documentation
This folder contains helpful resources relevant to validation execution. See details in the Executing Qualio Validation article.
Templates, samples, and resources will be updated as needed with the latest version and may not be reflected in the image above.
Qualio Policies & Certifications
These resources are commonly requested by customers for validation and supplier qualification purposes. They represent Qualio specific policies, procedures, and certifications.
When referencing these documents, we recommend customers provide the link to the FOLDER, not the document as the document links will change with any newly updated/uploaded version of the document. Document titles will not change version to version.
Posted content (as of April 1, 2023)
Data Security Backup & Redundancy policy
Software Development Life Cycle policy
Disaster Recovery policy
Change Management policy
Validation policy
Risk Assessment & Management Plan
ISO 9001 Certificate
ISO 27001 Certificate
Qualio Annex 11 Part 11 Assessment
Qualio Part 11 Compliance Assessment
Qualio Multi-Tenancy and Validation approach
To download from dropbox, click the button at the top of this article. Once the page has loaded, click the Download button on the screen.
Customers can adjust the Test Evidence video speed at their convenience by clicking on the gear at the bottom of the viewer, selecting Speed, and the desired speed to slow down or speed up the video.
If you’d like to share a link to one of the Qualio Validation folders or documents, you can copy the URL from the address bar instead of downloading the file directly.