Ok let me clarify...the data used from these systems is used in regulatory submissions (GLP data), and the system stores electronic records. So Part 11...
The Audit Trail requirement is applicable to the modifications of records required by the regulation. The other process of locking/unlocking records by...
Dear slammed, What do you mean by "unlocked"? If the original record still has an unimpeachable, irrefutable, computer-enforced association between it and the...
You are totally correct. It is a good practice to have controls on equipment. Even for research applications, equipment must be controlled. On those...
This is not about Part 11 or GAMP. It is about the practice of tracing data to an equipment level. Usually this is relevant during investigations and/or...
Part 11 is applicable, because this is data for submission and is managed electronically. Not because this data is stored electronically. You have the option...
I would say that no, I don't think you can get away with that. I'm basing that on the fact that in a corollary situation when dealing with QA and Regulatory...
akasharya74 From 21 CFR PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES ... § 58.63 Maintenance and calibration of equipment. ... (c)...
Thanks everyone! I was wondering if I could use 58.63 to convey my point across to the group, and I think I will! Unfortunately I'm getting push back because...
... managed electronically. Not because this data is stored electronically. You have the option of print reports, sign these reports, and submit the reports...
Hello all. Im in the process of having to create a new position within a CRO's IT dept called "IT compliance officer" This person's job description would be to...
If this person is reporting into IT isn't there a conflict of interest. The fox guarding the henhouse sort of thing? ________________________________ From:...
Greene, Brian
brian.greene@...
Jul 18, 2008 3:54 pm
18472
Hello, I was somewhat critisized for not showing a statistically significant sample size for running through a LIMS PQ. By sample size, I mean number of...
Once signed, that record must not be changed. The way to do it is to create a new record with the changes and sign it with the new one becoming the official...
Is the concern a system load issue (didn't stress the system) or didn't exercise all the functions? Did you not have any boundary values? I usually you do...
Based on the brief job description, it would not be a conflict of interest. From the description, they are responsible for writing SOPs and other tasks to...
As to training and experience, they should have a background in IT security, IT audit, and, preferably, Quality Assurance, with knowledge of the regulations...
I would look for ITIL (Information Technology Information Library) and COBIT (Control Objectives for Information and related Technology) training and...
Hi Greg, All functional testing and boundary testing done in OQ. The initial concern was that the PQ period was not long enough to excersize 'enough'...
For a simple document-record, that approach works fine. What happens when the document-record is comprised of data that spans multiple tables, table-records,...
So if you've done all the functionality testing in the OQ, and the PQ isn't being used to assess performance concerns (like performance under max network/user...
Similar to the process validation, a computer systems PQ test all the functionality together, not individual functionality. Another difference between the...
Read my email about this subject sent few seconds ago. Yes, I work in that level of detail if the computer systems PQ will also be used as the Process...
The difference between "process validation" when you're talking about a manufacturing process with many mechanical parts and a computer validation where people...
" Another difference between the computer systems OQ and PQ: PQ is performed by the user(s); and, for those systems with test environment and production...
It is not based in interpretation. You should read the process validation guideline and apply this guideline based on computer systems FDA CPG 7132a.11. ...
Where in there does it say that software PQ is done in a production environment by the end-user? I'm going off of the FDA's final guidance on General...
DB: I commend you for asking the question BEFORE hiring someone. This is a place where a lot of pharmaceutical companies go astray. Often there is an attempt...
A medical device guideline!!! It seams that you are jumping all over the place. Ok. You are absolutelly correct. Cheers, Orlando Lopez Sent via BlackBerry by...
"In addition to an evaluation of the system's ability to properly perform its intended functions, there should be an evaluation of the ability of the users of...
