ISO 13485 - Part 11: Electronic Records - Small Biotech Company - What is required?

[dauclair]

I'm hoping someone will come to my rescue and provide templates for the implementation of Part 11 in a small company environment that outsources IT. This project has been on the books for nearly 2 years and has been passed from project manager to project manager on a weekly basis until it has finally landed in my lap. I am the Document Control supervisor of a small biotech and am "resource challenged". What I'm looking for is help in establishing some of the basic SOPs for this regulation which covers configuration management, security, disaster recovery and system validation.

Is there anyone out there that could possibly help?

 

[Marc]

Anyone with ISO 13485 - Part 11 experience?

I haven't done an internet search for templates for SOPs for configuration management, security, disaster recovery and system validation, but I've not seen any here. If anyone can help out here I'd appreciate it.

 

[Al Rosen]

I'm hoping someone will come to my rescue and provide templates for the implementation of Part 11 in a small company environment that outsources IT. This project has been on the books for nearly 2 years and has been passed from project manager to project manager on a weekly basis until it has finally landed in my lap. I am the Document Control supervisor of a small biotech and am "resource challenged". What I'm looking for is help in establishing some of the basic SOPs for this regulation which covers configuration management, security, disaster recovery and system validation.

Is there anyone out there that could possibly help?

It's not surprising that you're having a problem with this. Part 11 does not refer to ISO 13485, but to FDA regulation (broken link removed)

The FDA is not yet enforcing the regulation. They have published (broken link removed) on the subject and have recalled some of them because of the confusion and Industry concerns.

I don't have specific part 11 templates, but the requirements can be incorporated into your existing procedures.

Here are some web sites that may be helpful

https://www.21cfrpart11.com/pages/library/index.htm

(broken link removed)

(broken link removed)

 

[Linda W]

I support software development and acquistion of software for our company- medical device - and we have have to comply with 21 CFR Part 11. FDA is enforcing this, you can find 483 letters from just last year on the website that shows they are taking this seriously. I have a requirements spec with some guidance for compliance that we use. If you are interested in seeing what we have created send me an email.

Linda

 

[Al Rosen]

I support software development and acquistion of software for our company- medical device - and we have have to comply with 21 CFR Part 11. FDA is enforcing this, you can find 483 letters from just last year on the website that shows they are taking this seriously. I have a requirements spec with some guidance for compliance that we use. If you are interested in seeing what we have created send me an email.

Linda

Hi Linda:
I have not seen any reference to part 11 on 483s listed on (broken link removed)
Is there another site? Can you attach the documents in the thread? Thanks.

 

[Linda W]

I found this site when I was trying to convey the importance of getting all of our software applications in compliance - We still are struggling with this issue.

(broken link removed)

 

[Al Rosen]

Linda,
Thanks for the link. Apparently the member who originally posted the request has not been back here since Nov 2004. In any case I will add some more links to reference material here.

21 CFR Part 11: A Detailed Overview

Complying with 21cfr part 11

Clinical databases & Part 11