Updated January 2026
September 2022 marked a pivotal moment for the life sciences industry. The FDA released its long-awaited guidance, "Computer Software Assurance for Production and Quality System Software" (CSA). This release confirmed what forward-thinking companies had anticipated for years: the era of paper-heavy, checkbox compliance was officially over.
Title 21 CFR Part 11, originally released in 1997, defined how companies should manage electronic records. For decades, this regulation and its 2003 follow-up guidance were treated as rigid rulebooks by Computer Software Validation (CSV) practitioners. The result was a culture of fear where every feature, no matter how low-risk, was tested with equal intensity.
Why the Shift was Necessary
By the time the CSA guidance arrived, the technological landscape had already transformed. Most regulated companies had moved from custom-built on-premise systems to configurable, off-the-shelf cloud solutions.
Traditional CSV methodology had become a bottleneck. It produced massive amounts of documentation that added little value to product quality. It ignored risk stratification, testing everything with a brute-force approach. This manual process was slow, expensive (often consuming 30-50% of project budgets), and prone to human error.
The Reality of CSA Today
In the years since the guidance was released, the "risk-based approach" has become the industry standard. Companies no longer validate to "tick a box." They validate to ensure quality.
Key Principles of the Modern Approach:
- Focus on Intended Use: Testing is concentrated on features that directly impact product safety and quality.
- Critical Thinking Over Scripting: Teams spend more time analyzing risk and less time writing "idiot-proof" step-by-step test scripts.
- Vendor Leverage: Companies now rely heavily on vendor qualification for low-risk features, avoiding redundant testing.
How Companies Have Progressed
The transition is complete. The "draft" phase is behind us, and the principles of CSA are now daily practice for efficient quality teams.
Validify was built for this exact reality. As a Salesforce partner designed specifically for regulated industries, our platform automates the risk assessment and assurance activities that CSA demands.
Automating the Assurance Process
Validify allows companies to apply the CSA risk-based approach instantly. Our automated tool eliminates the deliberation of when to start a validation cycle. Every run takes minutes, identifying exactly what configuration changes were introduced and which specific activities are required.
Whether it is a routine Salesforce update, a new internal process, or a third-party add-on, Validify analyzes and validates it without the manual overhead of the past.
Why contact us today?
- Zero Infrastructure: We offer a full SaaS model that requires no additional IT setup.
- Fast Implementation: Install from the Salesforce AppExchange in 10 minutes.
- Instant Analysis: Identify potential risks and mitigations immediately.
- Audit-Ready Documents: Automatically generate a complete set of validation documents that are ready for review.
Advance to the next level of computer software validation. Install Validify today!
About Validify
Validify Inc. is a Salesforce partner, the vendor of Validify, a Salesforce application that automates the risk analysis and computer system validation (assurance) processes for regulated companies, managing their product related processes on the Salesforce platform. Validify is an automated solution providing risk analysis of any Salesforce org and generating all necessary verification and validation documents based on risk and other predefined, configurable parameters. Validify also provides a real-time status of your org’s compliance and identifies changes in your org automatically.
About the author
Ido Raz is the co-founder and CEO of Validify. Ido has extensive experience in providing solutions for organizations in the life sciences and other regulated industries. He led global technological and implementation teams, specializing in providing IT compliance and quality applications. He is an experienced compliance and cGMP professional and a cloud technology enthusiast.
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