Dear All, Area of business of our comapny is GCP. I find this forum to be very useful and informative. On the same lines I would like to joing forum on GCP...
Mukesh Mahatma
mukeshmahatma@...
Sep 1, 2004 3:50 pm
12197
Hi, Infrastructure. You should validate the server. It contains the original raw data and it must be compliance with 21 cfr 11. You only can trust the data if...
Here's some background info for the discussion. Unity Plus is a stand- alone quality control program (SPC) offered by Bio-Rad Laboratories (www.bio-rad.com)...
We are planning to implement a learning management system(LMS) to cater to the training needs of ourcompany.The company wants to do a risk assesment to access...
Encryption is not a requirement for trusting the data, but you are correct that the system should have the ability to detect alteration of data. This can be...
Hi Jim, More companies now are doing network qualification, which covers your infrastructure. You need a clear set of requirements in terms of what files need...
I'm looking for the actual regulation or rule that states that all screens of a computer system must display the full user name of the individual logged in. ...
FDA appears to view training systems as "low risk". Training is a "secondary" quality attribute--it's not directly affecting the release quality of a product....
Computerized systems in clinical trials guidance. Pointed out to me long ago by a CRO doing clinical work with our software, but I've forgotten where exactly...
Verbatim, Part 11 does not state that it is a requirement to display the full user name of the individual logged in. However, it is stated in the FDA...
Hello, Infrastructure. I have also been involved in the validation of TOCs, and ChemStations where a user can use explorer to change the permissions. Since...
The requirement is in reference to electronic signatures. One example from the Preamble of 21 CFR Part 11: Section 11.50 requires signature manifestations to...
In the old days, we used microfiche/film to back up paper records. Can't think of another way of replicating that method since records could always be held up...
There is no such regulation, the vast majority of applications do not do this. ... Notice of Confidentiality: This message contains confidential information...
Risk level varies by company according to the process... When I speak at CV conferences I often use 'training system' as an example of a low-risk GxP system....
Hi All, Did anyone have experience validating software like softmax pro, no instrument validation required here. Can some one give some suggestions on what are...
You only need to display the full user name on an electronic record or a printed copy of that record, where an electronic signature is applied (ref. 21CFR...
I think that this is what you are looking for in Part 11: § 11.50 Signature manifestations. (a) Signed electronic records shall contain information associated...
It is not in a regulation but it is in one guidance, COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS (1999): a. The printed name of the individual who enters data...
COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS (CSUCT), April 1999 DATA ENTRY A. Electronic Signatures 2. The data entry system should also be designed to ensure...
Yes. I =assumed= from the original question that it was being used in standalone mode. Of course, every question in this forum should include the template...
The guidance on using computers in clinical trials (section A.2.a) states that: "The printed name of the individual who enters data should be displayed by the...
Hi Angela The following is a link to a warning letter referencing SOPs and Training Record deficiencies. http://www.fda.gov/foi/warning_letters/g3798d.htm If...
Fletcher, Debbie
debbie.fletcher@...
Sep 7, 2004 2:59 pm
12221
That's right Derek. In Section V.A.2.a, it says, "The printed name of the individual who enters data should be displayed by the data entry screen throughout...
... of TOCs, and ChemStations where a user can use explorer to change the permissions. ... mitigated this issue procedurally in an SOP. EXample: Users must ...
My company is looking at purchasing the S+ Statistics package. We currently have JMP in house and validated that package as a process. In other words we...
Link to an article about this topic http://www.labcompliance.com/part11/durable-media.htm ... Da: urspq [mailto:urspq@...] Inviato: 7 settembre 2004...
Hi Guys, Need some help as far as batch records are concerned for cGMP and Good Documentation Practices. Also thanks in advance for all the help. How valid is...
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