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FDAs Computer Software Assurance (CSA) – Part 1 of 3

Blog Home | Published: February 12, 2020

How to accelerate adoption of FDA’s Computer Software Assurance

This blog is the first of a three-part series focused on FDA’s Computer Software Assurance (CSA). It explains how to accelerate CSA adoption.

What exactly is CSA?

There are two primary things CSA delivers: First, CSA flips traditional validation from upside-down to a new way of thinking that’s right-side up. Second, Computer Software Assurance charts a path through a critical thinking process to ensure appropriate, risk-based, least burdensome validation.

Flipping the paradigm right-side up

With traditional CSV, too much focus is on documentation. The amount of time and effort put into documentation consumes significant resources and sacrifices critical thinking. CSA inverted this upside-down way of thinking whereby focus is placed first on critical thinking, then assurance needs, then finally testing and documentation.

 

QPA_down-369x300QPA_up-373x300

                Figure 1 - The old CSV way                               Figure 2 - The new CSA way         

Charting a CSA path through a critical thinking process

csv-1

Figure 3 - How to CSA(SOURCE: Cisco Vincenty, FDA Case for Quality Program Manager (FDA))

Identify Intended Use

The new CSA approach starts with identifying intended use. Here it’s determined if a system, feature, operation, or function directly impacts device safety, device quality, or quality system integrity.

ACCELERATE
ValGenesis’ VLMS accelerates
Critical Thinking
using System Assessment functionality to
identify the intended use

Determine Risk-based approach

The next step in the Computer Software Assurance process is to determine a risk-based approach, focusing in on safety and quality, specifically high-risk areas that may require the most rigorous assurance effort and objective evidence, which is complete, extensive validation and ensure the high-risk features, functions, or operations reliably perform as intended.

ValGenesis’ VLMS accelerates
Risk Assessments
with risk assessment functionality at
System level and Requirement level

Methods and Activities

Where CSA value shines bright is with leveraging a vendor documentation, ad-hoc testing, and automated testing; this is a risk-based, least burdensome approach. The biggest payoff is with medium and low risk features where little or no rigorous effort is required. Validation cycles are further accelerated by validation leveraging automation, iterative methodologies (e.g., Agile), along with continuous monitoring and verification. In other words, digitize validation and go paperless.

ValGenesis’ VLMS accelerates
Methods and Activities
using patented
Requirements Traceability Matrix (RTM),
Frameworks, and
Test Functions

Appropriate Record

Complete validation with a high degree of rigor is necessary for high-risk. For medium risk, less rigor can be applied. For low risk, little or no validation may be required. If it is in fact low, there should be no impact in the event of failure. If there is a negative consequence for a low-risk failure, then the risk assessment was inaccurate or the process is flawed.

VLMS accelerates
Appropriate Record
with
Electronic Execution and Deviation Management
to create and maintain validated state and records

Change Control is necessary to ensure changes to features, functions, or operations follow the CSA process. This maintains the system in its appropriate state (e.g., “Validated”).

VLMS accelerates
Appropriate Record Change Control
through
Change Management and
Periodic Schedule
to maintain appropriate validated state
on a continuous basis

Change the culture and process by igniting teams

Culture must change from a compliance-centric mindset to quality focused culture. This will be discussed in more detail in the next blog.

Next up…
Changing compliance-centric mindsets
(blog 2 of 3)

Resources

 

Summary

With traditional CSV, too much focus is on documentation. The amount of time and effort put into documentation consumes significant resources and sacrifices critical thinking. CSA inverted this upside-down way of thinking whereby focus is placed first on critical thinking, then assurance needs, then finally testing and documentation.



Author

Steve Thompson

Steve Thompson has worked in Life Sciences for over two decades in both Information Technology and Quality Assurance roles. He’s a certified systems auditor and has audited hundreds of companies globally. A published author, a frequent speaker at industry conferences, on the Board as a Director for PRCSQA, Editorial Advisory Board for ISPE, and Elite Faculty member for KENX, and Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program. He was honored with an APEX 2020 award of excellence for a peer-reviewed article he co-authored for Pharmaceutical Engineering on Blockchain. Currently, as Director Industry Solutions at ValGenesis, Steve helps Life Science organizations realize the potential benefits of advanced technologies, along with inherent risks.