Is CSA Really a Game Changer for the Life Science Industry?

Computer System Assurance (CSA) is a framework designed to help manufacturers within the Life Sciences industry achieve computer system validation (CSV). CSA clarifies the stance and methodology used to determine what high risk is and what is not, therefore minimizing misinterpretation by manufacturers (fact source – Computer System Validation vs. Computer Software Assurance (ISPE). It identifies common pain points; FDA’s current thinking puts patient safety and product quality at the heart of the risk assessment process.

When you are in Quality, you have two choices. First, you can decide to continue with no innovation. Second, you and your team can lead by industry regulating standards by having your validation and testing be fun and functional.

In the same way, CSA principles align with all Life Science companies. Computer Software Validation in pharmaceuticals can be considered an outdated practice. With the rise of CSA, medical device and biotechnology companies are partaking in FDA Computer Software Assurance.

Primarily, its industry knowledge of the FDA Guidance Computer Software Assurance Manufacturing, Operations, and Quality System Software, the FDA CSA guidance is currently delayed due to COVID-19. This delay has driven many in-depth industry discussions in the meantime.

However, the 21 CFR Part 11 computer system validation regulations haven’t changed over two decades. Computer System Validation doesn’t line up with modern-day technology. It’s time to revamp the Life Science Industry validation and testing approaches.

For this purpose, it may spark your team’s interest to discover an updated and digitized testing approach by viewing automation as a risk-reducing opportunity and not as a liability. The transition from CSV to CSA is to help you shift focus from creating documents to efficient testing cycles that will help reduce your firm’s overhead costs.

Five things you need to know about CSA:

1. Risk is based on the impact on patient and product quality measured against requirement complexity.
2. It calls for the least burdensome Doc. approach.
3. It reduces paperwork by 80% with unscripted and ad-hoc testing.

Unscripted testing does not mean un-documented.

4. It results in fewer issues encountered during production.
5. FDA & ISPE endorsed.

In addition, in knowing about CSA’s competitive advantages. You may be asking yourself why I should implement CSA at my organization now. The most common fallacy about CSA is not implementing it because the guidance hasn’t been released.

It is true; why are you waiting until the FDA Draft Guidance is officially released? The CDRH has the CSA Draft Guidance on their A-List Prioritized Documents to publish during the fiscal year of 2022. The FDA doesn’t want you to fear. Instead, invest in automation to help your company to keep growing.

Why Move from CSV to CSA?

• CSV is identified as a barrier by the FDA.
• 20% spent on documenting, 80% spent on testing vs. CSV 80% documenting, 20% testing.
• The FDA has found CSV principles too much and too expensive for companies.
• Easier to validate and test anywhere.
• Over 60+ Life Sciences companies have implemented CSA globally.

To illustrate, the FDA’s new approach to CSV, CSA, represents a game-changer in computer system validation, placing critical thinking at the center of the CSV process.

Transitioning from CSV to CSA:

• Change the culture of your organization from a compliance-centric mindset to quality-focused culture
• Leverage your software suppliers existing activities (perform supplier audits)
• Consider using computer system validation tools to automate assurance activities
• Know the intended use of your computer system(s).
• Know the computer system’s high-risk features, operations, and functions (s).
• Review and update your current policies to align with the CSA approach.

Most importantly, as you are following the proper transition steps. It’s imperative to leverage training after deploying any paradigm-changing methodology. We have noted from our many implementations here at Compliance Group. “Workshop” based training with real-life case studies are the most effective in bringing cross-functional groups together.

FInally, your firm can optimize CSA to automate your framework inside a life cycle management tool. ALM is the management of the entire application lifecycle. Siemens Polarion helps you define, build, test, and manage complex systems in a unified 100% browser-based solution that ensures seamless collaboration across disparate teams of all sizes. Polarion will ensure Automated Full Traceability, Accelerated Productivity & Automated Proof of Compliance regardless of the complexity of the size of your project and environment.

In summary, when we have a risky computer application, higher documentation and testing are mandatory. The soon-to-be-released CSA guidance will give the companies that are currently using automation, will lower their patient’s risks and a higher caliber of medicine.

Compliance Group is here to guide you through the new FDA CSA critical thinking approach. One of our CSA industry experts will gladly discuss your current state and recommendations. Call us at (847) 327-3167, ext. 406 or email sales@complianceg.com