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Computer Software Assurance (CSA). What does it really mean? Where does CSA apply in
Biopharma, Cell and Gene Therapy (CGT), and Personalized Cancer Vaccine (PCV)
manufacturing? What is the emphasis on data integrity when addressing manufacturing
software?

The CSA guidance recently released by the Food and Drug Administration (FDA) for comment
has spawned much chatter in the regulated life sciences industry. Much of this discussion has
put undue emphasis on what may not be required within the CSA validation model relative to
the burdensome Good Automated Manufacturing Practice (GAMP) model previously adopted by
legacy pharmaceutical manufacturers.

A more accurate way to interpret CSA is to realize that FDA is attempting to move from the
industry GAMP paradigm to a model more aligned with their existing general principles of
software validation guidance. In doing so, CSA explicitly replaces Section 6 of the FDA
Guidance, Validation of Automated Process Equipment and Quality System Software.

CSA reimagines testing with an emphasis on production and quality system activities, i.e., CSA
is not so much about tasks that may not need to be performed but more about pivoting toward a
heightened emphasis on testing of tasks supporting production controls. CSA enables this by
creating a binary approach to risk management; software functions that impact product quality
and safety have a heightened process risk category and require the focus of robust testing.

The CSA guidance also speaks to a continued emphasis on the integrity of data related to
production controls. Data integrity is essential to any pharma production process, but due to the
voluminous data generated, this is especially important in Biopharma, CGT, and PCV
manufacturing. It becomes incumbent on Biopharma, CGT, and PCV companies to use the CSA
guidance to create a risk management approach that satisfies this priority on identifying high-
risk functions and related data and then testing accordingly.

The intended use of automated Biopharma, CGT, and PCV production process systems would
classify as high risk requiring the rigor of formal documented software validation testing.
Contact Arbour Group for a more detailed discussion of software validation of automated
production and process controls, particularly as it relates to commercial solutions for regulated
Biopharma, CGT, and PCV manufacturers:

  • Rockwell FactoryTalk, PharmaSuite, Historian, Plex and Fiix
  • Dassault Enovia 3D Experience
  • Siemens Opcenter Execution, Teamcenter and Polarion
  • Honeywell Performix MES, PHD Historian and Sparta Quality Management
  • SAP MES, Mii and Advanced Track and Trace

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.

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