Expert Working Group submits Comments to FDA draft Guidance on CSA

On 12/13 September 2022, after around five years waiting time, the US-FDA released the draft Guidance on CSA, Computer Software Assurance, for comment. This document had been expected by the industry for a long time. After all, many things were told about CSA, but unfortunately they had not been written down until now.

Even if the Guidance seems to be supported by CBER and CDER, the document currently refers to 21CFR820 only; i.e. the main (and binding) focus is on  medical devices, in particular "for computers or automated data processing systems used as part of production or the quality system".

It is to notice that the CSA Guidance does not cover "design verification or validation requirements specified in 21 CFR 820.30 when applied to software in a medical device (SiMD) or software as a medical device (SaMD)". The FDA's intention is to replace Section 6 of the General Principles of Software Validation with this new guidance.

Although the Guidance does not primarily address computerised systems used for or supporting GMP activities, the ECA Foundation and its European QP Association have set up an Expert Working Group led by Yves Samson and with, amongst others, the following members

  • Philippe Lenglet, Laboratoires Servier
  • Jérôme Brindeau, Becton Dickinson (Pharma System)
  • Driss Houch, B. Braun Medical AG
  • Rob Stephenson, Robert Stephenson Consultancy
  • Britta Abellan
  • Bob McDowall, R.D.McDowall Limited
  • Éric Villain, Servier Monde
  • Jean-François Clavel, LSI
  • Quentin Hoyaux, EXPLEO Life Sciences Switzerland

to comment on the CSA draft Guidance. To find out more about the comments that were submitted, please see the following document. 

 Computer Software Assurance for Production and Quality System Software / 2022-09-13 - Comments from ECA Foundation & European QP Association    

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