Re: Fw: client asking me to ingore Part 11 in sw Val Saludos Laura, Are you aware that Part 11 is only applicable to Part 11 records? Part 11 records are defined by the US FDA Guidance for Industry, Part 11,
Re: Fw: client asking me to ingore Part 11 in sw Val Is this a technical question or an ethical question? Firstly, has the determination that Part 11 compliance is required been absolutely made? Perhaps this is
Robert J Beck
Re: Fw: client asking me to ingore Part 11 in sw Val Hi Laura It is up to the quality manager to advice senior management on the need to comply with the regulations. However, quality has no empowerment to
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Re: Fw: client asking me to ignore Part 11 in sw Val Is it device software or is it software used in the quality and manufacturing environment? If it's on the device, then Part 11 does not apply because devices
Re: Fw: client asking me to ingore Part 11 in sw Val There's a much more active group on LinkedIn: 21 CFR part 11 where you can get more opinions. You need a risk based assessment against the predicate rules for
Fw: client asking me to ingore Part 11 in sw Val I'm contracting as a software validation engineer at a major medical device firm. The entire corporation "chooses" not to comply with Part 11 and I'm being
Re: Future of this group Hi Vincent - please ask your questions Siegfried From: firstname.lastname@example.org [mailto:email@example.com] Sent: 07 December 2014 22:38 To:
Dec 29, 2014#21713
Re: Future of this group I have not been using this forum. Although I do have some questions about using Adobe and Esig compliance. Vincent Foley Quality Director Agere
Dec 9, 2014#21712
Re: Future of this group I think it is safe to say that Part 11 is essentially just another topic in the vast tapestry of compliance. Maybe a group devoted exclusively to it is no
Dec 9, 2014#21711
Re: Future of this group Dear Heather To me, you will find that you can get answers from some of the best experts in the field if you ask this forum Of course Part 11 questions are
Dec 9, 2014#21710
Re: Future of this group The LinkedIn 21CFR Part 11 Group does seem to get more traffic these days David David Stokes | Global Lead, Life Sciences Follow me
Dec 9, 2014#21709
Future of this group I have noticed that my compliance buddies are often using different forums for discussing 21 CFR Part11 questions. Is this still a useful forums or do you
Dec 7, 2014#21708
Re: Hardware Category 1 & 2 , GAMP 5 I have seen hardware used as a door stop and also as a paperweight...
Oct 7, 2014#21705
Re: Hardware Category 1 & 2 , GAMP 5 I agree, hardware by itself has no function. The only time it comes into play is when it houses an environment.
Oct 7, 2014#21704
Re: Hardware Category 1 & 2 , GAMP 5 Hardware is an entity it can be seen, measured and touched. As such it can be subjected to physical inspection and all routine test methodologies; GAMP 3/4/5
Oct 7, 2014#21703
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