Could someone point me in the direction to a Software Validation Procedure to use as a template for validation of our software which strictly handles the Complaint Handling Process? Thanks and any advice ect would be appreciated.

Good afternoon, and welcome to the Cove!!

Your question seems to be a fairly popular question, showing the rising scrutiny of validation requirements. Here are three threads that I found on software validation. I think I remember a couple of these having some template examples:

Pharmaceutical & Validation Protocol Listings? (http://elsmar.com/Forums/showthread.php?t=19074)

Software Validating Adobe Professional according to Part 11? (http://elsmar.com/Forums/showthread.php?t=18717)

Contradictions in Medical Device Verification vs. Validation - ISO 13485 (http://elsmar.com/Forums/showthread.php?t=19549)

There are several threads on this. You may want to perform additional searches to see if your question can be answered.

Also, I know the FDA website has some information. There have been those who state that it is vague, but it may provide a starting place.

I moved this to the Software Quality Assurance forum and retitled the thread to better represent the thread topic.

Hi,

Can any one help with software Validation template/format or sample?
I need to write one for a software for a medical device

Thanks


Good afternoon, and welcome to the Cove!!

Your question seems to be a fairly popular question, showing the rising scrutiny of validation requirements. Here are three threads that I found on software validation. I think I remember a couple of these having some template examples:

Pharmaceutical & Validation Protocol Listings? (http://elsmar.com/Forums/showthread.php?t=19074)

Software Validating Adobe Professional according to Part 11? (http://elsmar.com/Forums/showthread.php?t=18717)

Contradictions in Medical Device Verification vs. Validation - ISO 13485 (http://elsmar.com/Forums/showthread.php?t=19549)

There are several threads on this. You may want to perform additional searches to see if your question can be answered.

Also, I know the FDA website has some information. There have been those who state that it is vague, but it may provide a starting place.

Hi,

Can any one help with software Validation template/format or sample?
I need to write one for a software for a medical device

Thanks

Scotman,

You posted this question 6 (six) times. :confused: One question is usually sufficient to obtain a response from our Fellow Covers.:yes:

Stijloor.

Sorry... I am new here
Secondly, I am so stressed and puzzled and anxious for help in order to finish this project
:mg:

Scotman,

You posted this question 6 (six) times. :confused: One question is usually sufficient to obtain a response from our Fellow Covers.:yes:

Stijloor.

Sorry... I am new here
Secondly, I am so stressed and puzzled and anxious for help in order to finish this project
:mg:

Hi Scotman!

I sent you a private message (look in your "welcome" box in the upper right corner of the screen - it should be a green color indicating you have a private message) about this. :agree1:

If you could, please provide a little more information to give us some background about your company and situation, as it would be most helpful. :bigwave: And that is something we all love to do here, is help out whenever we can! :agree1:

Thanks I have tried that and downloaded some other forms I also needed but nothing specific to my original request.

We are a small business and cannot afford the $$$$$ consultant fee and trying to do-it-yourself prepare for a special 510(K) for adding a software to an existing therapeutic device already FDA cleared.

:read:


Hi Scotman!

I sent you a private message (look in your "welcome" box in the upper right corner of the screen - it should be a green color indicating you have a private message) about this. :agree1:

If you could, please provide a little more information to give us some background about your company and situation, as it would be most helpful. :bigwave: And that is something we all love to do here, is help out whenever we can! :agree1:

Sorry... I am new here
Secondly, I am so stressed and puzzled and anxious for help in order to finish this project
:mg:

Scotman,

Take a deep breath.... and count to 10...., relax and don't get too excited.

As Stijloor has mentioned:

Scotman,

You posted this question 6 (six) times. One question is usually sufficient to obtain a response from our Fellow Covers.

Stijloor.

It is proper forum etiquette to only post your question once. I understand that you are new, so that is why I am bringing this up.

If you need help in removing (deleting) your duplicate posts, just ask and one of the Moderators will be happy to help you.

Responses to posts are based upon proper and in-depth issues or facts. You need to be as specific as you can when asking a question. If the question is not specific, then it is highly likely that there won't be any responses, because fellow Covers will not understand what you are asking. This also helps other Covers that want to help you.

This thread has templates for software validation.

http://elsmar.com/Forums/showthread.php?t=10867&page=6