This message was posted by a user wishing to remain anonymous
Yes, with any reasonably robust system, basic revision control makes for repeatable results.
If you're troubleshooting an unstable system with intermittent errors in the hardware, operating system, software, or somewhere else, and you're trying to track them down using screen shots, or video of the users' hands on the keyboard, the GUI, thermocouple/oscilloscope readouts, etc., you're really not in the validation stage yet.
Original Message:
Sent: 21-Aug-2019 11:06
From: Dan O'Leary
Subject: FDA - Computer System Validation Guidance
I never use screenshots and always talk people out of them. Instead, I control the revision of the script and the revision of the software. Any test should, as a result be repeatable.
For the previous few years, I've been doing a lot of work with Excel software validation and this method works well.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 21-Aug-2019 10:32
From: Kamran Younis
Subject: FDA - Computer System Validation Guidance
It is about time to move away from the never-ending screenshots for CSV. Unforutnelty, old habits die hard and we have a lot of experienced people in the field "telling" companies that screenshots are the only objective evidence.
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Kamran Younis
Mr
Butler NJ
United States
Original Message:
Sent: 20-Aug-2019 13:54
From: Jackie Torfin
Subject: FDA - Computer System Validation Guidance
Hi All,
Yes, this came out of Case for Quality, and indeed Cisco Vicenty is part of the team working on it. I have attached a presentation given in March of this year with the progress and updates.
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Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States
Original Message:
Sent: 19-Aug-2019 14:21
From: Julie Omohundro
Subject: FDA - Computer System Validation Guidance
So true.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 19-Aug-2019 14:12
From: Dan O'Leary
Subject: FDA - Computer System Validation Guidance
In the list it is called "Computer Software Assurance for Manufacturing, Operations, and Quality System Software". This is the requirement in 820.70(i).
A quality or regulatory topic is not legitimate unless it has at least three ways of referring to it!
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 19-Aug-2019 13:58
From: Julie Omohundro
Subject: FDA - Computer System Validation Guidance
Thanks, Dan. I forgot I had also looked at CDRH's planned guidance list, which I found here:
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-fiscal-year-2019-fy-2019-proposed-guidance-development
I didn't see a guidance document with "computer system validation" in the title, and that's all I know of what Loganathan is looking for.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 19-Aug-2019 13:19
From: Dan O'Leary
Subject: FDA - Computer System Validation Guidance
Each year CDRH publishes a list of planned guidance documents in two parts. List A is the guidance documents expected in the fiscal year and List B is the "hoped for" guidance documents.
The guidance document for non-product software is on List A for this fiscal year.
I believe that Cisco Vincens is working on it. In any case, he did a series of webinars for Greenlight Guru and one of them was on the proposed guidance document. I believe they are posted on the Greenlight Guru website. It was part of a series, and you may not recognize it by the name of the series. (I think the series name had something to do with Case for Quality.)
Since FDA reorganized the website, I can't find the list.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 16-Aug-2019 11:42
From: Loganathan Kumarasamy, MS RAC
Subject: FDA - Computer System Validation Guidance
There was general talk in the industry that FDA is expected to release a Computer System Validation guidance this year. Did anyone hear anything about this? We still have the 2002 guidance that serves as the base for CSV and I'm looking forward to see the latest guidance from FDA.
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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
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