21 CFR Part 11 ?

21 CFR Part 11 ?

Post by EastCoastGuy » Tue, 28 Aug 2001 04:45:06



Is anyone here working in a QA job which requires you know 21 CFR Part
11?

I have seen QA jobs listed that have 21 CFR Part 11 as part of the job
requirement. So far I have seen this with Pharmacy companies. I located
that document and it is only several pages pertaining to Electronic
Records and Electronic Signatures. Is there more to this than those
several pages that a QA person needs to know?

 
 
 

21 CFR Part 11 ?

Post by Newsgroup » Thu, 30 Aug 2001 14:29:59


I am working on 21 CFR Part 11 for all aspects of the regulated
industries, including biologics, pharmaceutical, diagnostic, medical
device, clinical applications, and laboratory companies. Several
suppliers to the healthcare industry are also trying to make their
systems Part 11 compliant. The scope of Part 11 is therefore large. Any
computerized system under the GMP's, GLP's, and GCP's (predicate rules)
may be subject to Part 11. Compliance to this regulation typically
requires policies (for passwords, security, electronic signatures,
validations), procedures, inventories, assessments, validations,
training, and remediations. For instance, one part of the regulation
requires validation of computerized applications. This alone is a huge
task. Several validations of computerized systems I have worked on or
have reviewed approach 3000+ pages of test documentation and take teams
of validations specialists months to years to complete. One facility I
have worked with has over 100 applications that potentially fall under
Part 11 and must be validated as well as assessed to see if they comply
with 21 CFR Part 11. Validation of electronic records and electronic
signatures is quite large and complex. Gray areas include systems that
are hybrids, that is, applications that use both electonic and paper
records/signatures. Interpretation of the regulation is quite varied by
industry and by company. I am working with a client on worldwide Part 11
compliance project and the workload and systems involved is approaching
the scope of Year 2000 projects. Remediation is similar to normal
maintenance projects except you may have tens to hundreds of systems to
remediate. Some systems are being replaced instead of being remediated,
others are being retired.

As a suggestion, read the preamble to the regulation to get an idea of
the complexity and some of the interpretation that the FDA has made
already on the actual regulation. This may shock you as a user.

John Suzuki
JKS & Associates



> Is anyone here working in a QA job which requires you know 21 CFR Part
> 11?

> I have seen QA jobs listed that have 21 CFR Part 11 as part of the job
> requirement. So far I have seen this with Pharmacy companies. I located
> that document and it is only several pages pertaining to Electronic
> Records and Electronic Signatures. Is there more to this than those
> several pages that a QA person needs to know?


 
 
 

21 CFR Part 11 ?

Post by Jeff Barbou » Tue, 04 Sep 2001 12:20:43


I am the project validation coordinator for a compliance project to
remediate, replace, and develop a compliance plan for all computer systems
at multiple pharmaceutical sites.  I am a co-author of our corporate Part 11
directives.

NuGenesis began a website, www.21cfrpart11.com as a repository for field
related information.  Many other resources exist like the paper published by
the GAMP SIG on Part 11 and FDA clinical guidance.  Many opportunities exist
for training by consulting companies such as Taratec and professional
organizations such as the PDA and ISPE.

If you are looking something specific and can not find it on the web, email
me and I will send it if available.  I have attended many good seminars,
worked on numerous e-record/e-signature projects, and have presented systems
and the validation documentation to the FDA during inspections.  With all of
this background, I can tell you that hands-on exposure plus an intimate
knowledge of GxPs gained from experience can not be beat.

Jeff Barbour
Bayer Corporation


Quote:> Is anyone here working in a QA job which requires you know 21 CFR Part
> 11?

> I have seen QA jobs listed that have 21 CFR Part 11 as part of the job
> requirement. So far I have seen this with Pharmacy companies. I located
> that document and it is only several pages pertaining to Electronic
> Records and Electronic Signatures. Is there more to this than those
> several pages that a QA person needs to know?