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21730

Re: Audit management tool

Hello No, the audit document is not electronic record, as per the Part 11 requirement. It is a document the FDA have stated they will ask to review and it is
albridgeuk
Jun 13
#21730
 
21729

Re: FDA Electronic signatures vs Digital signatures

Yes - According to Part 11, and in simple terms, a Digital Signature is a form of Electronic Signature that can be verified after the act of signing. This is
david.stokes28
Mar 17
#21729
 
21728

Re: FDA Electronic signatures vs Digital signatures

You're talking about a scanned signature? I would still require entry of intent of signature and electronic password
laura jones
Mar 16
#21728
 
21727

Re: FDA Electronic signatures vs Digital signatures

Thanks Jerry I was wondering what are the issues in making Adobe compliant? Also, I was referring to actual digital signatures as you mentioned vs scanned docs
rpinto779
Mar 16
#21727
 
21726

Re: FDA Electronic signatures vs Digital signatures

Saludos, Yes, it can be used. A digital signature is a type of electronic signature. Cheers, OrlandoSent from my iPhone On Mar 16, 2015, at 1:04 PM,
Orlando Lopez
Mar 16
#21726
 
21725

Re: FDA Electronic signatures vs Digital signatures

Certainly. Let's make sure we're on the same page with terminology: a digital signature is a form of electronic signature that uses digital certificates,
Jerry Anderson
Mar 16
#21725
 
21724

FDA Electronic signatures vs Digital signatures

Can digital signatures be used as Electronic signatures as defined in 21 CFR Part 11?
rpinto779
Mar 16
#21724
 
21723

Re: Audit management tool

Saludos, The validation process is a good practice to all computer systems. Validation is required for systems performing regulated operations. The complexity
Orlando Lopez
Mar 10
#21723
 
21722

Re: Audit management tool

I would not validate such a tool - it's a long way from any direct impact on product safety or product quality. I would assess it for fitness for purpose and
david.stokes28
Mar 9
#21722
 
21721

Re: Audit management tool

It depends on the product. I think during an intensive FDA inspection, if it were not validated in some way this would be an audit finding. It depends
Robert J Beck
Mar 9
#21721
 
21720

Audit management tool

Hi, just wanted to hear your position whether an audit management tool to conduct IT audits for GxP relevant IT systems needs to be validated. What is your
maltinpolar1
Mar 9
#21720
 
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
 
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
 
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
 
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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