Description
Why it is useful
This template will help you perform the performance qualification (PQ) in accordance with planned and documented arrangements.
How to use it
1. Establish a performance qualification protocol for each process that is to be validated.
2. This template serves as a baseline for what should be included in a PQ. What is required for a PQ depends on the process being validated. Tailor the template to include the information required for the applicable PQ by adding and removing information as appropriate. Once this is done, sign the empty template on the first page. This becomes the PQ protocol.
3. If you work with a paper-based system, you can copy the approved empty PQ protocol. Thus, the copied version becomes a form that will be filled in by hand when performing the performance qualification, which will then be the record from the PQ.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customised to work with the current project.
Support
If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on
this link when you are logged into your Medical Device HQ account.
Need process validation training and a course certificate?
Take a look at our online course:
Process Validation for Medical Devices. Learn key validation techniques, how to identify which processed need validation, and maintain a validated state. Created by industry experts. Certification on successful completion of course.
