The following was posted to a tech writers' list that was discussing how companies hit by the New Orleans tragedy could recover their electronic data. The...
Annex 11 Computerised Systems is also detailed in the current UK Orange Guide. (Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002) ... ...
Fletcher, Debbie
debbie.fletcher@...
Sep 5, 2005 4:06 pm
14240
Hi all, just have a question on the audit trail side of things. We work within a cGXP environment and are currently looking into making sure we are compliant....
We only activate the Excel "audit" trail for spreadsheets that save data. We stongly discourage users from saving data in spreadsheeets if possible. We have...
I'm new to this group and overwhelmed with the mass of messages. Not sure where to start, but maybe I'll start by asking some questions in hope to get some...
Hi to all: I need 2 different solutions and I would like to know your feedback. One solution I need is for a system that can provide a feature of document...
All, ... Welcome! ... The greatest difficulty seems to be interpreting the regulations for your sites requirements. Then, working out the limits of validation...
Juan, We are currently using File Tracker from Tab software for the doc check in check out. Works well. There are a ton of vendors that provide both types of...
First welcome to the CFR world, where "you can check out any time you want, but you can never leave." Q1. What are the challenges you face with the overall CFR...
Anyone know how to get a copy of the now released ... Draft GAMP SIG Validation of the IT Infrastructure guidance document? I just searched the site and can't...
The ISPE website http://www.ispe.org/Content/NavigationMenu/Publications/ISPE_Technical_G uides/GAMP_Good_Practice_Guides1/GAMP_Good_Practice_Guides.htm shows...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Sep 7, 2005 2:25 pm
14249
A couple of questions I am presently dealing with: 1. Is an ERecord a single logged/historized record or a complete electronic log? 2. In present releases of...
This is my continuing path for clarity on ERecords and criticality: Based on Jerry's 4 questions below and based on the FDA's definition of an Electronic...
Contrary to popular belief (And this is my opinion only). E-records and E-Sigs relating to Part 11 are abused almost to the point of insanity. This was...
Hi rpolacse I think you will get a number of different opinions, without context it is difficult to be specific. 1) both are but the second might not be...
Sims, Fraser
fsims@...
Sep 7, 2005 4:54 pm
14254
Just coz its Gold doesn't mean it is! I suggest you re read point 22 in the preamble of the actual regulation AND the guidance document issued in August 2003 ...
Sims, Fraser
fsims@...
Sep 7, 2005 4:54 pm
14255
... It depends on your definition of the data and what kind of data you're dealing with. ... It's more like you go in and change a result in a piece of...
Q6. You are SO right about consultants behaving like experts and companies sounding like God almighty. I have been to several conferences on validation, a...
Hello all. I am new to this group but I am overwhelmed with the questions asked and excellent responses. I am working on the barcode validation project -...
Poonam Isarani
poonam.isarani@...
Sep 8, 2005 1:57 pm
14258
Just a note of clarification - part 11 does not actually apply to software that runs on a medical device. The device software is covered by design control....
Hi Fraser, Having no real idea of the working environment or predicate rules applying to the situation, I found it curious that MS anything is being used for a...
As with many responses on this board - it depends. How are you using the barcoding system? If is it used inconjuction with GxP related activities (tracking...
One more great source of information is......wait for it..... the FDA. Turns out that most of the folks who work there are not out to wipe the medical industry...
Hi Paula The solution we have implemented is a plug in that works straight out of the box and is compliant, though you will have to produce your own validation...
Sims, Fraser
fsims@...
Sep 9, 2005 8:04 pm
14263
I know I wrote a lot in my previous message, but I did not say anything about Part 11 applying to records created by a medical device software. I will take it...
The same agency by the name of FDA has issued a 483 citing 21 CFR 11 violations for medical device embedded software in 2004. The inspection took place at the...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Sep 9, 2005 8:04 pm
14265
Just to add to this: The FDA has issued 483's and Warning Letters to both medical device manufacturers and pharmaceutical companies citing computer validation...
ludwig_huber@...
Sep 11, 2005 10:20 pm
14266
Hi On a related topic, we have started evaluating InfoPath. Is any one using it??? If so what problems have you found??? For those of you who have not come...
Sims, Fraser
fsims@...
Sep 12, 2005 10:33 am
14267
This is a good solution but limited. Further, any use of forms requires a change log, clearly noting any change to any field in a form, with a date and user...
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