How complex is your environment? What kind of risks are involved in the project? Are you writing code for a small group or a huge corporation? Are you...
Actually, our IT groups are very good with developing and maintaining the URS, FS and DDS documents. The groups I'm referring to are in production or...
Another aspect when considering development documentation for computer system is maintenance and further development, once the project is initially "closed"...
You need to have a sound LIMS in place complying with the OOS and triggering CAPA. You could look out for LabVantage LIMS / StarLIMS etc.. Regards Sarang ... ...
Hi, I'm leant to think that your solution does not quite resolve the problem, which intrinsically is the definition and syncronisation of the developer's...
Hi validate to death - In reality, the first time a new system is set up, a team of super users create the URS and the FS (Func Req.). The developer takes the...
Young, Loretta
loretta.young@...
May 1, 2006 5:58 pm
15366
I understand (and agree with) Siegfried's assessment. I *am* an IT person, and in my experience with many many projects, the lines-of-business, end-users, and...
Hi I have a different opinion on this case. Version control of documents and records means maintaining a proper tracable record of the changed data, with the...
... (snip) ... In my experience, they are not. And the reason they are not is very simple - once the system goes live, people trust the system more than they...
MW- Since you're taking a turn down the development methodolgy road... IMO, there is an inverse correlation between complexity of the application and the...
Here is my reality... User: "You want me to write a document that explains what I want? Are you kidding me." No just start programming. I'd love to see the...
Hello MW, There is some truth to your statements. Engineers, by their nature, want to "play" with an application. To figure out how the system works or how to...
i agree with this post, this can be an easier process so that it's actually done rather than ignoring the process because it's a pain. when i've worked on...
Hi, I completely agree with MW. Most validation documents, once executed, never again see the light of day because people instinctively realize they are a ...
... I disagree. If something worked properly in the past and does not now work properly, what you call static snapshots of the past are a good way to pinpoint...
Jon David
jon@...
May 2, 2006 5:37 pm
15375
Hi We supply Commercial Off-The-Shelf software to pharmaceuticals. I'm confident that our SDLC docs are always up to date. This is at least partly due to the...
John Dickson
john_dickson55@...
May 3, 2006 3:11 pm
15376
Well, you could have a business analyst or a subject matter expert helping out with the requirements gathering. Leaving that to the users is -at least- little...
I'd suggest a couple of reasons for this lUser(*) behavior. One is related to money. If I'm asking someone to build me a house and I'm going to be paying, out...
Certainly, yet it does not mean the non-compliance situation is not in there. 21CFR11 is not a predicate rule that points upwards to these, therefore, it is a...
Still I think that does not quite answer validatetoDEATH's question. Do you keep your docs up to date in order to build a better product or do you do it simply...
Hello Everyone, We are in the process of evaluation EDMS and Submission Publishing solutions to support our clinical and regulatory groups. We have been using...
We keep them primarily for our own purposes. The fact that there is a regulatory requirement for documented evidence helps. Siegfried ... From:...
Schmitt, Siegfried (G...
siegfried.schmitt@...
May 4, 2006 2:05 pm
15382
Hello, I am new to this list (I am working in the chemical Industry in Switzerland) and have a question/problem: I scan an original record on paper (e.g. Batch...
Jean Claude, You have to make sure to specify in a document related to archiving the Batch Record (such as an SOP), which of the copies(hard or electronic) is ...
Tom Mizukami did the group a great service on being able to search the archives -- thanks to Tom! Below is his post on it. Happy searching. Regards, Joe ... ...
I'm sure you will get different answers and different angles of thought on this issue. I will share my thoughts. 21CFR 211 states that records can be...
There is also the site http://www.innovatum.com/sp11.php Greg Ventura ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of...
Hi WE looked at it and felt we could not make it be compliant to the regulations so are looking at proper ERMS systems (originally MS had included some...
Sims, Fraser
fsims@...
May 4, 2006 6:50 pm
15388
Thank you very much for this answer, Margaret. I hope I can convince people in my company they can discard the paper copy. They always say that if we have an...
Thanks for the kudos. Unfortunately it was a good idea that didn't quite work. Either somone changed the password or Google saw people logginig in from IP...
Having problems with message search?
Fill out this form to ensure your group is one of the first to be migrated to the new message search system.
