Accelerating Computer Software Assurance (CSA) readiness

The journey toward “Assurance”

The life sciences industry is moving at a swift pace toward digital
transformation as a result of Industry 4.0. This has led to the need for an
optimized regulatory and compliance approach to systems development and maintenance. The current state of system validation is perceived as an impediment to faster deployments, wherein the focus is on good documentation practices rather than building systems which are fit for their intended use.
 
A risk-based approach to validation has been around for some time;
however, companies have been challenged with identifying software risks and
the desired level of validation effort. This is where an enhanced focus on
critical thinking is required.
 
Industry and regulators are working toward various initiatives, such
as “Case for Quality,” to align on an optimized approach, and, in that
regard, the Food and Drug Administration (FDA) is moving to update its guidance on the validation of good practice (GxP) systems. The new FDA guidance being drafted, CSA for Nonproducts Manufacturing, Operations, and Quality Systems Software, focuses on high-risk GxP elements, simplified documentation, and automation to help achieve compliance with regulatory requirements.
 
In this point of view (POV), we:

• Share current challenges, thoughts on CSA
  leading practices, and how critical thinking can be leveraged to drive
  overall efforts to help achieve quality and compliance
• Outline an approach to shift from “Validation”
  to “Assurance”
   
  
  

Shift from “Validation” to “Assurance”

Some changes that we envision as part of Quality 4.0 and CSA:

Quality by design: Developing regulated systems and conducting validation (in this case, “assurance”) efforts to build quality into the system, as opposed to a more “compliance checklist” effort.

Risk-based approach: Tailored risk management and testing approach to help achieve confidence in system operation and performance. This includes automation, exploratory, unscripted, and limited scripted testing; increased use of tools; and leverage of supplier documentation to help avoid duplication efforts.

Future of testing

The testing space will continue to evolve and will be one of the specific focus areas to move quality at the speed of business. A few techniques that should be considered when strategizing an assurance approach are as follows:

• Configuration and experimentation
• Exploratory testing
• Automated testing
• Unscripted testing
• Scripted testing

Read the POV to learn what each of these techniques are and how they can be used.

Chart out a road map to make the transition from CSV to CSA

As we await FDA guidance, organizations in the life sciences space should start thinking proactively.

• Create a transition plan: Identify the projects and systems that have both direct and indirect impact on patient safety, product quality, and data integrity, and start applying CSA principles.
• Embrace the change and get your organization ready: Focus on the need for new skills and CSA training for the organization.
• Embark on digitization and automation: Conduct gap assessment against current manual processes in SDLC to identify potential opportunities for digitization and automation.

Get in touch

Vamsee Dasaka
Senior manager
Deloitte Risk and Financial Advisory
Deloitte & Touche LLP

Swarnali DasGupta
Associate vice president
Deloitte Risk and Financial Advisory
Deloitte & Touche LLP