Qualio recognizes the shift to Computerized System Assurance (CSA) will take thoughtful planning and valuable resources to execute and record. After-all, we also had to shift some of our policies and procedures.
To that end, our Quality Team has assembled some tips customers can leverage when creating their transition plan.
What should my validation transition plan include?
We’ve compiled the following change control recommendations to consider in your validation transition plan record:
Define your business needs and intended use of Qualio
Define your business processes and risk assessment. Get details here.
Document the specific configurations for your use of Qualio (i.e. number of days for training completion, which document templates require training, etc.) Get details here.
Review and/or update applicable policies or procedures based on the new ISPE GAMP 5 guidance
Streamline your validation processes, with particular focus on high-risk activities: product quality, patient safety, data integrity
Leverage vendor documentation as proof of the quality/integrity of the system - Qualio has ISO 9001 and ISO 27001 certification, and can provide validation support documentation
Requirements traceability matrix: reconcile the requirements traceability from old to new validation approach (Included in new validation packs)
Optionally, include a Memo regarding the new validation approach. Click here to download.
What should my new validation record include?
We recommend including the following in your validation support documentation record:
This sounds like a lot of work….
Defining your business needs, intended uses, processes, configuration specifications and conducting risk assessments now will allow your organization to make risk-based decisions on where to focus on validation efforts.
Taking the time during this transition will allow your organization to streamline your validation efforts, and help you assess any changes specific to your defined business needs, processes and intended use.
Implementing the CSA approach will shift the validation experience from one driven by documentation compliance to one driven by quality best practice and critical thinking.
What do I do when the validation support documentation updates?
When validation support documentation updates are released with new features, Qualio recommends you review your configuration specification, business process and policies.
Assess if the new features or releases impact your business processes, policies, or how you have configured Qualio for your intended use.
Since the bulk of Qualio updates are incremental, minor functionality improvements, most changes should have only a minor impact when they happen.
What if my organization wants to stick with IQ, OQ, PQ and the historic validation approach?
Qualio can provide our installation configuration documentation. Requirements and test scripts are provided in the validation support documentation in Gherkin text, and can be used to generate the desired format for the documentation.
You can then perform the validation of your system at your own discretion.