22.4 release updates

Starting with the 22.4 release, the Product Verification Pack (PVP) includes changes specific to certain folders in the pack.

A new Master Verification Plan is introduced

A standalone Master Verification Plan has been created to provide an overview of the Oracle Clinical One Platform and Oracle Clinical One Digital Gateway testing and documentation being generated for releases.

Updates to the ReadMe.txt file

When reviewing the PVP, the first document to reference will still be the ReadMe.txt file. This document has been updated to provide a comprehensive folder structure and documentation location for each release.

Updates in the Requirements document folder

Oracle is providing the following updates to this folder:

• Updated the Verification Summary Report (previously the Overview document). This document will detail the testing and retesting, results achieved, objective evidence and failures for the Oracle Clinical One Platform and Oracle Clinical One Digital Gateway release.
• Updated the Requirements Document. Previously, a cumulative requirements document was generated and supplied in the PVP. With the 22.4 release, only those requirements tested for the current release will be provided in the PVP. The document will be smaller and more manageable for our regulated customers to review. The cumulative requirements document will still be available, on request, as a standalone static document which will have all release information through the current version.
• Introduced a new 21 CFR Part 11 Control Mapping Document. We are providing a mapping document to help our regulated customers cross reference our 21 CFR Part 11 controls tested to GxP requirements listed in this document.

Updates in the Test Scenario folders

Under the Test Scenario folders, all Oracle Clinical One Platform and Oracle Clinical One Digital Gateway documentation has been combined. In previous releases, testing documentation was separated from the objective evidence. Starting with the 22.4 release, testing and objective evidence for Standard Control testing (regression testing) and requirements testing will be combined into respective folders. Under the Requirements folder, each requirement will be a standalone document and includes the objective evidence to help our regulated customers review those requirements pertinent to their own validation testing.

Note:

Oracle believes the upgrades to our documentation will help accelerate your review and evaluation prior to the Production release. If you have any feedback, reach out to your Project Manager or Customer Success Manager.