A number of patients died in this instance written about in Baseline Magazine: March 4, 2004 "Why Software Quality Matters" 'We Did Nothing Wrong' Panama's...
Just checking my understanding of current scope of Part 11 regs: In the US, solid oral dose form drug products (tablets, capsules etc.) must be imprinted with...
Hi Olivier, just an opinion, I agree with your point of making password security important to access electronic regulated data, just as you do when you control...
Raj, that means that in order to forge a signature in an electronic system, then more than one person must be involved, making the case for "conspiration" to...
Anybody have any opinions on using Documentum for 21 CFR part 11? Best, Maria T. Marchioni Documentation manager ... From: 21cfrpart11@yahoogroups.com...
Maria, We use Documentum within our GxP environments for SOPs, validation delivarables, clinical protocols/reports, etc. In my opinion, the system can be...
Hi all, The bellow explanation is correct if we use the correct technology (e.g., digital signatures). By using plain User-Ids and Passwords stored in a flat ...
Maria, when you refer to "user Documentum for 21 CFR Part 11" what do you mean? Using a workflow tool for capturing e-sigs, using document database for...
Usually 70% on security of infrastructure is about technology. The other 30% is about the procedural controls and training. These procedural controls are...
I don't think we'll have to wait that long. Read the link below, http://money.cnn.com/2005/07/19/pf/security_biometrics/index.htm "Schmitt, Siegfried (GE...
Tulio Luna
gmpauto@...
Aug 1, 2005 8:07 pm
14057
Documentum is widely used in the regulated healthcare industry for Document Management and Part 11 compliance. My opinion is that Documentum is really...
gmp_dude, I have a quick question. What Documentum functions and features did your company use for 11.300(d) compliance? "(d) Use of transaction safeguards to...
Good morning Orc, As you seem to know me from the infamous Runcorn days I'll try to lend a hand :-) I think this database needs to be assessed in the terms of...
Dear Bill, Exactly, mainly people's experience with using Documentum 5.3 for operation's content management. Maria T. Marchioni Documentation Manager ... From:...
Can excel spreadsheets be used as records? Such as logging incoming documents, tracking status? If not, are there easy ways to make them compliant to...
Hi Maria, See the message 13876 sent before. Olivier. ... [mailto:21cfrpart11@yahoogroups.com] On ... records? ... etc.) ... This ... products, ... unique ... ...
Hi Juan, In our company, we do not make a difference between quality system (SOP, training, configuration control), qualification and validation. We perform...
Maria, For applying e-signatures, the account is locked after 3 failed signature attempts. This events ends a message to several Documentum admins. The sys...
Orc, IAMAE but here's the way I'd look at it. Does the system: A. Create unique identifiers B. Store unique identifiers created by some other method If it's A,...
My company is considering the creation of a dedicated test team for our IS applications. I was wondering if 1) Do you have a dedicate testing team for IS...
211.180 (d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other...
It's too easy to spoof the sender. There is no proof that the sender actually agrees to what is in the email so they must be signed. I prefer a simple typed...
Maria, in response to your question “Anybody have any opinions on using Documentum for 21 CFR part 11?” and with the understanding that you’re interested...
And if the answer is yes, there are several commercial "addins" that can bring 21CFR11 compliance to Excel or Access. Alternatively, you could hire a...
In the patent interference case of In Re Scott Jolley (interference numbers 103.525 and 103.526 October 29,2002), the US Court of Appeals for the Federal...
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