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21734

Re: how to disable delete option from registry

Atit, assuming that the HPLC application does NOT require the Delete permission at the folder level to properly function (e.g. older Chemstation versions
Harry Acosta
Dec 17, 2015
#21734
 
21733

Re: how to disable delete option from registry

Have you tried changing the file attributes to make them read-only?
david.stokes28
Dec 17, 2015
#21733
 
21732

how to disable delete option from registry

Hi everybody, I am using standalone system for HPLC analysis, at present we have to run the system on standalone computers. I have tried to disable delete and
atitdesai120580
Dec 17, 2015
#21732
 
21731

code management requirement

Curious what level of code management your organization is doing (i.e. for housing code for custom applications, or code for systems like LIMS). I couldn't
akasharya74
Jul 28, 2015
#21731
 
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, 2015
#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, 2015
#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, 2015
#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, 2015
#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, 2015
#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, 2015
#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, 2015
#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, 2015
#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, 2015
#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, 2015
#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, 2015
#21720
 
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