As an existing customer, you’ve already completed initial validation of Qualio when you first implemented Qualio at the beginning of your contract. However, now that Qualio has shifted to a Computerized System Assurance (CSA) approach, we strongly recommend our customers also update their approach to validation.
This can feel overwhelming if you don’t have a dedicated Customer Onboarding Manager to assist you like you had during initial validation. That’s why we’ve put together this article with specific instructions for customers that will accept all Qualio recommendations as well as test evidence and documentation. And if you get stuck, our Support Team has been trained to assist customers with the specific steps listed in this article.
If you aren’t yet sure that you want to adopt Qualio’s recommended CSA approach to validation, please review this Qualio Validation Overview article and watch this recorded customer webinar.
Step 1: Retire Effective Validation Documents
During initial validation you may have used our “example” Validation Plan, Validation Summary Report, and other validation related documents. Or perhaps you had your own existing documents to support your software validation policy. Either way, you’ll need to retire your effective Validation related documents.
Click here for instructions on how to retire documents in Qualio.
Step 2: Review and update validation document template(s) in Qualio
Next, take a look at your existing validation related document templates. We’ve simplified our recommended validation process to require only one validation document template that we’ve titled Qualio Validation Document and assigned a template ID of QVAL-. We recommend you update your validation related document templates to match what we describe below and archive any extra validation-related templates you may have.
The QVAL- document template has one section header titled “Qualio Validation Information” and the recommended document template properties are listed in the screenshot below.
If you decide to edit an existing document template to mirror what we’ve described above, here are instructions on editing templates. You will most likely delete any existing drafts tied to an existing template because they no longer comply with the recommendations of this article.
Step 3: Create new Qualio Validation documents
In this step you’ll be creating 3-4 Qualio Validation documents using the QVAL- document type. We have examples of each document for you to access, review, then copy/paste into a new QVAL document.
First Document: Start with the Validation Plan
Browse to the Support Documentation Dropbox folder.
Download the Qualio Validation Plan - Example document.
Open and review the document noting the yellow highlighted items that will need to be updated / customized to your organization’s details.
Review the Business Process Description and Risk Assessment sections to confirm you agree with the provided standard text.
In your Qualio production instance, create a new document.
Select the Qualio Validation Document type.
Title the new document: Qualio Validation Plan
Apply tags, reviewers and approvers as necessary then click Continue.
On the Change Control tab indicate that this is a new validation document created to align with the updated CSA approach.
In Editing mode, on the Document tab, copy and paste the content of the example Qualio Validation Plan into the one and only section of the document.
Format any text as needed and update any yellow highlighted text to your organization’s details.
Second Document: Create the Qualio Feature Validation document
Similar to the Validation Plan document described in detail above, access and download the Qualio Feature Validation - Example document from the Support Documentation Dropbox folder. Then use the content from the example to create a new document in Qualio.
Select the features that your organization utilizes in the table provided and update the yellow highlighted text throughout the document with your organization’s details.
Review the Latest Val Pack
This is a good time to review the most recent Validation Pack, or Val Pack, to understand how Qualio provides test video evidence and documentation with each release. Similar to the rest of this article, we are assuming you will accept Qualio’s validation testing, but we recommend that you still review the Val Pack to ensure you are familiar with what was tested and updated.
First, browse to the Feature Val Packs Dropbox folder.
Within this folder you will find a unique Val Pack folder for every release after January 2023. (We started using Launch Trains to organize our releases in 2023.) Identify the most recent release based on the folder title which includes the month and year of the release.
Within the Val Pack folder you’ll find individual folders for the different features. Open and review the contents of feature folders if you have implemented that feature.
DCC-[#]-review-package [feature]. Within this folder you will find documentation of each feature’s user needs, user story, test plan, requirements traceability matrix, and a change history pdf describing what has changed from the previous release. We recommend you review all these documents in order to confirm that your organization requires no additional testing and that you plan to use the features inline with what was described in the User Need and User Story documents.
Test Evidence (screenshots and videos). Other folders will be nested within the feature folder to contain test evidence in the form of screenshots, videos, or other documentation. We recommend that you also review the test evidence to confirm that Qualio has successfully executed the testing as described in the test plan.
Third Document: Create a QMS Platform Configuration Specification (OPTIONAL)
You only need to create this document if you’ve implemented the Suppliers or Design Controls feature because those are the only two configurable features in Qualio.
Similar to the Validation Plan and Feature Validation documents described in detail above, access and download the example QMS Platform Configuration Specification document from the Support Documentation Dropbox folder. Then use the content from the example to create a new document in Qualio.
This document will represent your baseline configuration and will need to be updated if the configuration changes.
Fourth Document: Create the Qualio Validation Summary Report
Similar to the other three validation documents described in detail above, access and download the example Qualio Validation Summary Report from the Support Documentation Dropbox folder. Then use the content from the example to create a new document in Qualio.
Update all yellow highlighted text to your organization’s details. You’ll need to confirm the Business Processes and Risks identified do not require further information based on your evaluation.
Step 4: Review, and Approve all new Validation documents in Qualio
Now that you have multiple draft documents you’ll want to add/update Smartlinks in the Validation Plan to reference the other validation documents, and vice versa. Then, if applicable, send the draft documents to be reviewed if you’ve listed Reviewers. And lastly, send the documents for approval.
Once approved, you can celebrate that you’ve successfully migrated to the modern CSA approach to validation. Good job. Just remember that validation isn’t a one-and-done exercise. With each release comes the potential need to revalidate.