Yes, we have done extensive testing of it too, and while it has some warts, it is also quite nice - better in Office 2003 than Office XP (have tested both)....
Guida, Richard [JJCUS]
RGuida@...
May 3, 2004 1:10 pm
11474
FDA expects to quantify the validation process. It would include screen shots, descriptive actual results and documenting all the deviations with Meta data....
hi everybody, I am A.balaphanisekhar newly joined to his group ,iam presently working as quality assurance executive, i would like to know more about gap and...
... Once we have completed the risk assessment, we have documented the computer system and automated system hazards surrounding quality, compliance (records...
Bob, Where is this happening (anywhere)? I would love to see the statistics on this or any other password stealing in pharmaceuticals. It's a lot of "what...
Dear Sir/Madam, We are one of the leading pharmaceutical companies in India and in the process of compliance to Part11 guidelines.We have the following...
sundhar
sundhar@...
May 3, 2004 1:13 pm
11480
Jose, I am really not sure, we will use CAPA, but I am unfamiliar with it, and it has been yet to be rolled out. From it's name however, I believe it would...
Graham, Once we have completed the risk assessment, we have documented the computer system and automated system hazards surrounding quality, compliance...
Personally, I find it unnecessary to keep the records generated during validation of a system IF you've got a complete paper validation package. It's...
We never keep the database long. When validation is complete we archive it to CD. Greg Ventura ... From: skaternum [mailto:skaternum@...] Sent: Monday,...
How do you ensure that the records can be read and that the meaning is preserved in future (15 year +)? Do you also archive to CD the application software at...
Lillian Milis
lmilis@...
May 4, 2004 9:34 am
11485
All our data is currently in SAS data sets. Any future version of SAS should be able to read an older version. What do you need a 15+ year retention period...
I would advise people not to use Office 2003 quite yet if they generate LARGE documents. I have experienced quite a few problems with documents greater than...
I've been off-list for a while and don't know if this topic has been discussed so I apologize if I'm crossing old trails. Has there been discussion here...
Client of mine experienced a hardware failure during testing. We recorded the deviation and variance, and then proceeded to retest from the beginning... Do I...
I have another client who has been visited by the FDA and received a turbo 483 that states the audit trails for its instrument system must be reviewed. FINE......
Hello - I was wondering if anyone plans on attending the public forum on June 11th, aka the request by FDA to receive industry input on the new ruling that...
Krista Woodley
woodley@...
May 4, 2004 8:46 pm
11491
Of course, one of the bigger problems is having the hardware or OS to read a datafile. Of course, windows will be around awhile, but how many people still ...
Yeah, you might want to search back through this group for this topic. Quite a lot of discussion. This is a pretty good search engine for this group: ...
Question: if this change didn't happen during validation, would a CC be necessary? If so, yes, if not--no. Simple? That's my opinion. However, personally...
Hi Krista, I wish I could attend the FDA forum on June 11 but I am tied up at that time. The new Part 11 guidance was meant to help us (and it has) but it has...
Now we are getting into migration. We no longer have any 5.25" floppy drives. When we were down to our last PC with this kind of drive, we started migrating...
Dear All, Question concerning Audit trail retention and archival. To give some context, at the moment we're replacing the current LIMS system, using old...
They will most likely not come out with a list of "required documents". If they did that would most likely mean that they would have to advocate some...
Does this imply that auditing changes to system configurations (i.e. adding users, new attributes, deleting users, adding new screens, adding new documnet...
Audit trail records are perfectly acceptable to be archived, as long they are restorable, accessible, searchable and under GXP/P11 controls. You must have...
Pam: "regulated operations" would depend on what type of software company you are. If you are including your software as part of a medical device then parts of...
John DeFazio
John_DeFazio@...
May 6, 2004 1:49 pm
11502
Greg, I agree with you. It will be hard to say to use one methodology. I was just hoping they would spell out certain methodologies and tell us to use it. I...
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