Pharmaceutical & Validation Protocol Listings?

[suziwann]

I am interested in reading about Validation Protocols for the pharmaceutical industry and in general. I did a search here, but am absolutely lost.

Can anyone post me a link please?

[gszekely]

Hello Suziwann !
I have posted some links I know for medical device industry here:
Are there any new regulations for Medical Devices?
Check out them, maybe you get some useful info.
BR
György

[suziwann]

Thanks for that György!

I had a look the other day but was unable to open the page.

I had to register, but there are some very useful things on that Exactly what I was looking for!

[suziwann]

http://www.clinivation.com/pages/res.../downloads.php There is a whole load of free QMS documents there.

[psyched1]

Here is a version of our software validation protocol which the big pharmas keep approving during audits. I wonder how it would hold up to FDA scutiny?

EQ-04-F1 Software Validation for cove.doc

Names were changed to protect the innocent.

[Kevin Mader]

Psyched1,

The document you posted has some useful information but I'm hopeful that there is a program behind the document. By itself, I think that FDA would have issues. In the end, it will be the quality of the planning and execution records that will demonstrate burden of proof.

Regards,

Kevin

[BradM]

Psyched1- thank you for posting the article.

As with Kevin's comments, I think your document would work well as a standard template for protocols given it's fairly generic nature.

However, there were several things I did not see that I would think would need to be there. Electronic Records/Electronic signature, data integrity, backup, archive, data integrity, data security, etc. would need to be addressed also. I think there are several others, but I thought of a few off the top of my head.

[psyched1]

Thank you all for your comments. Software validation is a challenge with limited guidance from the FDA.

We are in the pharmaceutical labeling industry so FDA audits seldom occur however we do have monthly customer audits. Fortunetly most Quality Auditors are either QM's with no time on their hands or entry level Quality Auditors and do not have a software background.

Due to my perfectionistic nature I need a robust system that could withstand an FDA audit.

In the PQ section 1. User Verification Testing Plan and Timeline we document how data intergity across platforms will be tested. This is done by having three complete data sets within the system and verifying consitstancy across platforms.

Section 2. "Accessibility" is where we address back up and archival processes which is also stipulated in our IT Procedure and security testing. This is an area for contention since we are a small (65 employee) company do not have the time or labor to validate ever permitation or string of code at every terminal. Instead we verify accesibility on three user codes then attempt to access the system with bad codes at each terminal. We also do the same with each permission/security level for the software and try to access those higher functions.

Its not perfect and I have lots of questions about finding short cuts to validate security (passwords). I also think I need to inprove this form and include software life cycle.

We do not use electronic authorizations/signatures in our facility and find it easier to require a hard copy of any document with a signature.