Meeting the FDA’s New CSA Guidance for Validation

  • Published:
    September 20, 2022
  • Category:
    Med Tech

This Just In: New FDA CSA Guidance

The FDA recently released new draft guidance on CSA validation. We’re proud to say that here at Apprentice, we already adhere to all of these regulations, and more. 

Read on to learn about the latest FDA guidance on software validation, and how we’ve future-proofed our software to stay on top of these evolving regulations.

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What Is the Purpose of CSA Guidance?

CSA, or Computer Software Assurance, is a modern approach to software validation spearheaded by the FDA and drafted in 2022.

This approach is intended to reduce the documentation burden of the previous Computer Systems Validation (CSV) method, but not at the expense of product quality or safety. 

Through the application of critical thinking, or rigorous and ongoing data evaluation, pharmaceutical companies can use CSA to ensure compliance without getting weighed down by the overdocumentation previously demanded by CSV.

“CSA is the application of critical thinking to validation that adds risk- based documentation to risk-based testing while taking a lifecycle approach, to “take credit” for activities, and reduce the validation effort.”

Ken Shitamoto, Head of IT Quality Engineering, Gilead

What Does the Latest Draft CSA Guidance Entail?

In September of 2022, the FDA released draft CSA guidance for pharmaceutical manufacturers.

As the FDA explains, the purpose of this guidance is twofold:

  1. Describe "computer software assurance" as a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate; and
  2. Describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR part 820 (Part 820).

In other words, this guidance is intended to both define the new CSA approach, and to elucidate the testing methodologies that will be needed to fulfill it.

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It’s important to note that this guidance is still in draft form, and is not expected to be finalized until later in the year.

CSV to CSA: What Does This Mean for Pharma?

The industry shift from CSV to CSA will trigger a number of changes in the pharmaceutical industry. Chief among them is the increasing emphasis on critical thinking as a validation tool.

To adhere to the existing CSV methodology, manufacturers need to spend around 80% of their time creating documentation, and only 20% of their time on the actual testing.

With CSA, the FDA wants manufacturers to shift this approach so that they can spend the bulk of their time and efforts on testing and critical thinking.

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The increasing weight of critical thinking in the shift from CSV to CSA [source]

While critical thinking will be the new main focus of the CSA approach, testing certainly isn’t getting lost by the wayside.

As Ken Shitamoto, Head of IT Quality Engineering at Gilead explains, “CSA does not reduce testing; CSA advocates more testing with less documentation. It is more important to remove defects than to collect documentation for inspection purposes.”

“In this latest FDA guidance on CSA validation, it’s exciting to see a growing acceptance of agile development methodology in GxP-touching areas. This will allow pharmaceutical software providers to move faster by lowering the documentation burden, while allocating more time to perform testing to the high impacting critical areas.”

Michael Martone, Manager, Quality Systems, Apprentice

The intent of this new approach is to free up more time and resources for high-level analysis and risk assessment of the data that’s tested. In other words, to work smarter, not harder, in software validation.

Compliance Is Our North Star, not an Afterthought

Here at Apprentice, we’re proud to say that compliance is built into everything we do.

That’s why we’re ahead of the game in this shift to CSA, instead of needing to play catch-up with this latest guidance.

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We’ve built our system with future guidance in mind, and this latest update just takes us one step further in our mission to unlock the full potential of technology in the pharmaceutical manufacturing space.

We’re always looking towards the future. That’s why when you partner with us, you get to stay ahead of the curve and on top of evolving regulatory guidance.

Want to find out more about how we can help your company achieve and maintain validation requirements? Reach out to our team today to get started.

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Tempo: A Platform Built for Pharma Compliance

Tempo is built on a quality management system, robust validation, and a proven audit process — all specifically designed for the life sciences.

Our Tempo Manufacturing Cloud is:

  • Designed for regulatory compliance. Tempo adheres to the most stringent pharma and tech standards and regulations around the world.
  • Compliant with cGXP Standards. Our system is regulatory compliant and fully validated by 3rd party auditors to be cGXP and 21 CFR Part 11 compliant.
  • Adherent to requirements for ongoing validation. We can provide all IQ and OQ documents, while our 3rd party validation provider can partner on developing PQ to ensure easy validation of the system.

With Tempo, you’ll get a fully validated platform that’s:

  • Consistent with ALCOA+ Principle
  • Executed independently by an experienced third-party partner, CompliancePath
  • Assessed against regulatory guidelines for the control and integrity of electronic data
  • Built to provide execution and documentation of IQ & OQ to every customer
  • Able to apply a streamlined strategy for PQ for customer-specific configurations

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Looking for More FDA Resources?

If so, we’ve got you covered. Check out our content library for more resources on achieving and maintaining FDA compliance: