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21719

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,

Orlando Lopez
Feb 19
#21719
 

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21718

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
Feb 19
#21718
 

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21717

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

Schmitt, Siegfried
Feb 19
#21717
 

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21716

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

Finner, Doug
Feb 19
#21716
 

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21715

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

therealbigb
Feb 19
#21715
 

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21714

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

laura jones
Feb 18
#21714
 

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21713

Re: Future of this group Hi Vincent - please ask your questions Siegfried From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] Sent: 07 December 2014 22:38 To:

Schmitt, Siegfried
Dec 29, 2014
#21713
 

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21712

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

Vince Foley
Dec 9, 2014
#21712
 

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21711

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

Greg Ventura
Dec 9, 2014
#21711
 

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21710

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

Schmitt, Siegfried
Dec 9, 2014
#21710
 

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21709

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

David Stokes
Dec 9, 2014
#21709
 

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21708

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

heather_longden
Dec 7, 2014
#21708
 

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21705

Re: Hardware Category 1 & 2 , GAMP 5 I have seen hardware used as a door stop and also as a paperweight...

david.stokes28
Oct 7, 2014
#21705
 

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21704

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.

Robert
Oct 7, 2014
#21704
 

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21703

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

albridgeuk
Oct 7, 2014
#21703
 
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