I agree that it's prudent to put a digital signature on it if you're concerned about the integrity of the data. However, I have to comment about the editing...
In the world of a contractor, you work almost entirely through email. Highly confidential reports, protocols, faxes, data, instructions, on and on. Word...
A couple of things: Whether or not you use email does not impact whether or not your system "open" or "closed" which pertain to who has control of your system...
Does anyone know if this website is still being managed and/or updated? I have tried to contact them several times and have heard nothing back. Thanks, SJ -- ...
Updates to the www.21cfrpart11.com site have begun. 'Contact Us' is working again. Please use the contact form to notify us of any specific requests or ...
What are Non confermence Reports in orthopedic device manufacturing compnay any idea? -- KGadhiyas [Non-text portions of this message have been removed]...
I guess it does. I have made an attempt in the past to no avail. It seems like some questions get acknowledged while some get totally ignored. From:...
Jamal Adekunle
jamal_adekunle@...
Jan 5, 2009 10:29 pm
19007
The moderator replied to this question immediately. See http://tech.groups.yahoo.com/group/21cfrpart11/message/19003. On Mon, Jan 5, 2009 at 2:52 PM, Jamal...
Hello, Nonconformance reports should be written whenever a product does not conform to specifications. The report should include an identification of the...
Greg M., With my apologies to the USArmy Core of Engineers and M. Calonne, Practical solutions we do immediately. Perfect ones take a little more time. There...
I am not aware of any method to reliably secure a PDF file. A determined adversary can easily defeat any built-in (i.e., within Adobe Professional) or...
Oh Please! I am always concerned when we expect or rather demand that electronic systems are perfect when the paper systems they replace were not. Why is this...
Jeffrey - Amen. How secure is any security and what are we willing to pay for practical measures? The Lunar Landing? It's refreshing to hear another...
I am right there with you. Individuals have taken this Part 11 opportunity to help build empires and wealth. The more complicated it sounds, the easier it...
Hello! We sell a software system used in fda regulated environments. Does anyone know the fda regulations on when re-validation practices should take place? If...
I apologize (hopefully before I get executed by well wishers). I just re-read my statement and while it was clear to me at the time, it was lacking when I...
Although I am not going to disagree with the intent of your post, the world you describe is long since passed, to be replaced by the post Enron, post Madoff,...
Re-validation may not be the correct word. When you release a new version, bug fix, etc. It is the responsibility of the company using the software to decide...
Other people will probably answer your question more directly than I will. I have a question for you. You do not consider fixing a bug in the software a new...
What procedures you do internally to manage your design are up to you. What you provide the customer is up to the contract between you and your customer. ...
As a software manufacturer, do we have to validate our product (software) for it to be considered compliant, or is it the responsibility of the client who buys...
From my perspective (Biotech, Pharma Company) The goal of a software vendor is to produce a quality product in which they understand compliance aspects (audit...
The vendor cannot validate the product as validation covers actual use in the user's environment. The manufacturer won't know, for example, if the user...
Hello all, I am putting together "Validation Policies" for all computer system GxP. In GAMP 5 (page 81) theare is a summary but I need to expand. I hope...
I know that GAMP recommended that a manufacturer follow some specific standard framework, model or method like ISO, CMMI o others in order to produce a system...
While you, as the manufacturer, do not need to validate your product, I, as a client, would want to know that the systems you design are created and tested...
Your software is not 21 CFR 11 compliant - it is "enabled". Compliance involves steps that only the end user can complete. Start with a completed 21 CFR 11...
When I started in the computer validation business, before 21§11, we had two concepts, verification and validation. As software developers, we verified the...
Dux, Tom
tdux@...
Jan 9, 2009 2:51 pm
19028
Tom you bring up a very good point, namely that there is no universal definition of the term validation. Therefore, one should describe what one understands by...
