Hi friends, Is there anybody who has idea about the general ratio of cost of validation to the cost of the system? 30%? 50%? And is there any reference on...
Hello Tom, Difficult to put a figure to this. It depends on the application/infrastructure you refer to. Highly gxp? Highly gxp and you have a planned FDA...
I am working on a White Paper at the moment for the next version of our software relating to customer ROI. Part of the White Paper will deal with validation...
Graham, would it be possible to get a copy of the white paper or the chapter that are related to validation (without giving up confidential information)? ... ...
Hi Difficult to answer this but I would have thought, generally speaking, that a figure of 50% (+) would be an accurate guideline. It does of course depend on...
Hi All, I have conducted a research study on the cost and optimisation of IT compliance in 4 mid-size pharma organisations (one a division of a global top 10...
I would (respectfully) take issue with your final statements. Firstly, the common market perception at the moment is that automated validation only involves...
Hi, we are a non-clinical CRO and are considering purchasing a digital xray machine. The company can provide DICOM conformance statements. And the x-ray...
Thanks Graham. I fully understand your position and I don’t disagree with it, but -in my experience- the reality on the ground is that there aren’t many ...
Hi Marie, One note regariding part 11 compliance is that no removal media (burning to CD ROM) can be used as electronic records. You probably need to...
I definitely agree with these points. The response time of the Life Sciences industry is typically very slow when it comes to adopting new ideas. The other...
Why do you need to be compliant, if you are non-clinical? Greg Ventura ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of...
Just a comment on the ROI of automated test tools. Any significant system that is validated only "once" is always in fact tested numerous times both prior to ...
Also, this is ambiguous: <quote>ratio of cost of validation to the cost of the system? </quote> Say for example validation cost is 50k, system cost excluding...
John Dickson
john_dickson55@...
Sep 3, 2009 9:07 pm
19612
There is nothing in the Part 11 regulation prohibiting use of any type of media ( e.g., CD ROM). It would just need to be used in a compliant manner (e.g.,...
J B Sorry to be the ogre here, but that is just factually incorrect. Removable electronic media is acceptable to all US Federal Agencies under all CFR's as...
To be Part 11 compliant it would need to capable of meeting all applicable requirements of Part 11, and would have to be validated. I would start with (before...
Hi John, You are correct. There is a lot of muddled reporting on this topic and it pays to be rigorous in examining what is behind reported numbers and...
Just some numbers that are guidelines to consistently request fundings across the organization I obtain these... "The range of validation estimates for...
Tom L, We have found it very difficult to find organizations that are willing to share cost information about regulated software projects. Good luck in your...
The emphasis on computing validation cost misses an important point. I've seen deployments in non-regulated companies suffer many costs that regulated ones...
Good point Darrell. When considering the costs of validation, one must also consider the costs of not validating. Another point that needs considering is good...
Typically, 30% - 50% of overall project costs was not unusual 5 - 10 years ago. I'm appalled that some people are still quoting these figures as current. More...
I know it seems strange responding to my own message, but someone contacted off-line about the figures I quoted, suggesting that in general the industry is...
I am waiting for final clearance on releasing a White Paper, The Impact of TCM on the Cost of Validation. It is complete and awaiting editorial and legal...
Graham, First off, thanks for the effort! Sorry, but I'm going to have to take a poke at your "get the ball rolling comment." The Hollis Group has been...
