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Computer System Assurance: Why We Need A New Approach?

The document discusses a shift from computer system validation (CSV) to computer system assurance (CSA) in the pharmaceutical industry. [CSV has become overly focused on documentation rather than assuring system quality. CSA is a new FDA guidance that shifts the focus from documentation to critical thinking and testing based on intended use and appropriate risk levels. CSA aims to improve quality and efficiency while reducing validation costs and times.]

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249 views

Computer System Assurance: Why We Need A New Approach?

The document discusses a shift from computer system validation (CSV) to computer system assurance (CSA) in the pharmaceutical industry. [CSV has become overly focused on documentation rather than assuring system quality. CSA is a new FDA guidance that shifts the focus from documentation to critical thinking and testing based on intended use and appropriate risk levels. CSA aims to improve quality and efficiency while reducing validation costs and times.]

Uploaded by

T 1
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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COMPUTER SYSTEM ASSURANCE

A Paradigm Shift from Computer System Validation?

It’s been around two decades when the concept of Computer System Validation was
first proposed with the idea to improve the quality of pharmaceuticals. Since then,
the industry has evolved tremendously in the area of automation, but the way
validation is done, hasn’t changed significantly. It’s not only burdensome in terms of
documentation but hinders the introduction of technology and automation in the
manufacturing and operational space. As per the industry experts “CSV has
morphed into an activity done primarily to secure evidence for auditors, rather than
to assure the quality of systems”.

Why we need a new approach?


To meet the ever-increasing demand and quality within the timelines,
pharmaceutical industry is moving to Pharma 4.0. A huge amount of efforts (time
and material) are being invested to drive this automation. Regulatory bodies also
believe that the use of automation, information technology and data solutions
throughout the life cycle can provide significant benefits to enhance quality and
patient safety
In contrast to this, CSV practice is still the same and has become synonymous to
extensive testing and comprehensive documentation for the validation of a system
software which becomes an obstacle in the process to move to a more automated
environment.
Some of the limitations with current CSV practices are

• More focus on documentation instead of system intended use


• Duplication of vendor efforts at the client sites
• Excessive levels of document review
• Unnecessary requirements of screenshots/ reports etc. at every test step
• Most of the defects and deviation due to testers
• Complicated Risk Assessments without the right focus on appropriate risks
areas
• Over validating everything

Computer System Assurance: A Better Approach?


The FDA, recognizing industries CSV challenges, has announced new guidance on
“Computer Software Assurance for Manufacturing, Operations, and Quality System
Software.” In brief it is a shift from document focused CSV practices to critical
thinking Assurance practices.
Approach to CSA
• Focus on identifying intended use
• Shift from Documentation to critical thinking and testing
• Applying the right level of rigor to the level of risk
• Leveraging the trusted supplier data
• Appropriate use of Scripted and Unscripted testing
• Documenting appropriate records

Figure 1: From CSV to CSA

Benefits as we shift from CSV to CSA


• Improved quality and efficiency
• Better use of trusted supplier provided documents
• Reduction in cycle times (e.g. Testing)
• Lower number of defects
• Over 50% less validation cost and time
• Capability to deliver value faster

Conclusion
Computer system assurance is a cultural paradigm shift. CSA shouldn’t be
considered a replacement of the current CSV approaches as defined in ISPE GAMP
5 but is a reinforcement or reinstatement of the fundamental principles focussing
on “intended system use”, “risk-based approach” and “leveraging trusted supplier
activities”. The release of the CSA guidelines by FDA will support companies which
have taken the path to automation, leading to lower patient risks and higher quality
products.

Vijayendra Aswal

References
• https://qbd.eu/en/blog/computer-systems-is-assurance-the-new-validation/
• https://www.continuousvalidation.com/blog/2019/10/30/noprivyno-is-your-cloud-app-validation-
program-fda-csa-ready
• https://www.csolsinc.com/blog/csv-to-csa-a-paradigm-shift-in-computerized-systems-approaches-or-
not/
• https://www.complianceg.com/

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