Description
Why it is useful
This template will help you perform the installation qualification (IQ) in accordance with planned and documented arrangements.
How to use it
1. Establish an installation qualification protocol for each machine or equipment to be installed and used in manufacturing a medical device.
2. This template serves as a baseline for what should be included in an IQ. What is required for an IQ depends on the equipment being installed. Tailor the template to include the information required for the applicable IQ by adding and removing information as appropriate. Once this is done, sign the empty template on the first page. This becomes the IQ protocol.
3. The approved empty IQ protocol can be copied and becomes a form that will be filled in by hand when performing the performance qualification, which will then be the record from the IQ.
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.
