Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Does anyone know the FDA's release schedule for the 2019 Guidance Document for Computer and Software Validation?  I understand a new "modernized" document is due to be issued in 2019.  Does anyone have a copy of the DRAFT document that was out for review?  I am in a unique situation as a field service team for a large medical device manufacturer selling to large pharma companies.  Several questions came up in a recent customer audit that I believe will be clarified in the new release.  Thank you!

The plan is to issue it this year according to Steve Niedelman's presentation at the FDA News Medical Device Quality Congress; it is on the CDRH A list. They have not yet released the draft. The planned title is "Computer Software Assurance for Manufacturing, Operations, and Quality System Software".

Greenlight Guru conducted a series of webinars on FDA's Case for Quality. In the fourth one, October 18, 2018, Cisco Vicenty from FDA spoke on Non-Product Computer System Validation. He outlined the problem and described the planned approach. I believe that much of this presentation will form the basis for the guidance document.

Check the Greenlight Guru website to see if you can gat a copy of the presentation and, perhaps, the audio.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 29-Apr-2019 07:00
From: Anonymous Member
Subject: 2019 Guidance Document "Computer Software Validation.." FDA

This message was posted by a user wishing to remain anonymous

​Does anyone know the FDA's release schedule for the 2019 Guidance Document for Computer and Software Validation?  I understand a new "modernized" document is due to be issued in 2019.  Does anyone have a copy of the DRAFT document that was out for review?  I am in a unique situation as a field service team for a large medical device manufacturer selling to large pharma companies.  Several questions came up in a recent customer audit that I believe will be clarified in the new release.  Thank you!

Dan - Thank you for the update.  I do have the Greenlight Guru presentation.  ​I appreciate you input.

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[Whitney] [Davis]
[Quality Specialist III]
[Instrument and Enterprise Services]
[Thermofisher Scientific]
[Marietta] [OH]
[USA]
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Original Message:
Sent: 29-Apr-2019 09:08
From: Dan O'Leary
Subject: 2019 Guidance Document "Computer Software Validation.." FDA

The plan is to issue it this year according to Steve Niedelman's presentation at the FDA News Medical Device Quality Congress; it is on the CDRH A list. They have not yet released the draft. The planned title is "Computer Software Assurance for Manufacturing, Operations, and Quality System Software".

Greenlight Guru conducted a series of webinars on FDA's Case for Quality. In the fourth one, October 18, 2018, Cisco Vicenty from FDA spoke on Non-Product Computer System Validation. He outlined the problem and described the planned approach. I believe that much of this presentation will form the basis for the guidance document.

Check the Greenlight Guru website to see if you can gat a copy of the presentation and, perhaps, the audio.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 29-Apr-2019 07:00
From: Anonymous Member
Subject: 2019 Guidance Document "Computer Software Validation.." FDA

This message was posted by a user wishing to remain anonymous

​Does anyone know the FDA's release schedule for the 2019 Guidance Document for Computer and Software Validation?  I understand a new "modernized" document is due to be issued in 2019.  Does anyone have a copy of the DRAFT document that was out for review?  I am in a unique situation as a field service team for a large medical device manufacturer selling to large pharma companies.  Several questions came up in a recent customer audit that I believe will be clarified in the new release.  Thank you!