Hi Can someone please help me here. How many years does data need to be archived? I have heard 8 and 10, but have never seen this outlined anywhere... ...
There is no single number of years for all GXP data. You will need to review the predicate rules associated with the data you are archiving to determine how...
Lisa Morton
mortonl@...
Jul 1, 2004 8:35 pm
11768
That depends the type of data you are archiving. If you are arching for Regulatory reasons (namely the FDA) you need to be aware of the predicate rule...
Unfortunately this is not a view it is just a plain fact. Re 1) How can you test the software that will be in a device without the device????? which is...
You miss one salient point and that is validation is not a destination it is a journey. If you discover incomplete specifications or anomalies then you go back...
Drug Safety System is nothing but SAE (Serious Adverse Events) reporting system. There are two major players in the market (I think Argus and the other one was...
Depends what it is I guess the answer is. I've heard seven years is the legal requirement for retaining legal documents, and was to that batch records and the...
Andrew Gibson
agibson@...
Jul 2, 2004 12:32 pm
11774
Paul, You are absolutely right. I was merely making a stand for the place of the writer within the tech world. The better the communication, the fewer the...
To clarify some points in this debate over specs and test plans: If the URS and other specs are written by competent people, as opposed to more-or-less copying...
Hi, I want to point out that there is "software validation" and therefore I have to object the plain fact :-). This term is widely known in software ...
Unless you are asking about the GLPs and non-clinical systems. Wells Horton PO Box 191 Woods Corners - Bldg 42, Floor 2 Norwich, New York 13815 Office (607)...
horton.cw@...
Jul 2, 2004 12:33 pm
11778
There is a commercial product on the market called ARISg which facilitates adverse events reporting. The adverse events need to be reported once the product...
Depends on the regulation, for example: Sec. 820.180 General requirements. ... (b) Record retention period. All records required by this part shall be retained...
I guess I'll wade into this. Andrew (and others) are right that "it depends". My experience is such: the Legal department wants to minimize exposure to ...
Hello All, Here is the latest update for <http://www.21CFRPart11.com>. ______________________________________________________________________ CONFERENCES &...
Did you finalize the vendor? any suggestion? Still we are evaluating the vendors. We are planning to integrate the LIMS with Document Management System to keep...
One further point, It's a good idea to have the schedule approved. For the reason that when documents start to get shredded and someone tries to make it sound...
Andrew Gibson
agibson@...
Jul 6, 2004 1:25 pm
11785
Applied Biosystems was claiming to have done this with SQL*LIMS. I have seen a demo but have not tried the product. ... evaluating ... to ... experience ... ...
HI, could anybody help me out with the info reg the sales force automation (SFA) tools available in the market. does the 21 CFR Part 11 reqs and other GxP...
At the moment I am having a discussion on what QA-signatures that are required on documents written for the qualification (IQ, OQ and PQ) of a computerised...
When it comes to document destruction, GxPs are silent; you need to go to business law. Basically: 1) There must be a procedure on destroying...
James Vesper
jvesper@...
Jul 6, 2004 6:25 pm
11789
Yes, that's a given that the schedule would be approved and would be part of an SOP (or policy) document. I think anyone working in our industry understands ...
Your both questions seemed the same to me. However the entire qualification document with all test scripts should be pre-approved by QA. This demonstrates that...
Jim, I have to disagree with you on the regulations aspect. Document retentions are based "at minimum" on GxP regs but the company can store for more than that...
Lots will disagree (probably)- but my interpretation is that for human drug production (21 CFR 211), there are no QA signature requirements for validation...
Agree with you and Graham. While it is true that software validation cannot be done without the hardware and hence Paul's view that documents should be...
Hi Jo Thanks for your reply. What I really think is happening here is that we in the pharmaceutical industry "validate" lots of systems and equipment and this...
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.
