IQOQPQ Validation Protocol Helps

Hello,
My company is using a software (FreezerPro) an inventory management system software for our material we store for our biorepository. Is there anyone who can help me create an IQOQPQ protocol to validate this software? We can speak about details of what we need in IQOQPQ protocol.

Regards,

Bashar Deeb

 

First off, software validation does not necessarily equate to IQ/OQ/PQ. Those are terms carried over from process validation / equipment qualification. PQ, for example, typically doesn't make much sense for software.

Second, there are no hard-and-fast rules on how to validate non-product software like this. In 2022, FDA published a (still) draft guidance on Computer Software Assurance for Production and Quality System Software. That outlines, IMO, a VERY reasonable approach to non-product software validation (assurance). While still in draft, many large companies are already adopting the approach.

So to answer your question, yes, I can help you with software validation. Feel free to PM me.

 

Hello Yodon,
Do you have availability tomorrow to speak with us regarding software validation we have availability 8 - 9 am PST. I can create a team call just please provide me with an email to add you.

Regards,

Bashar