Updated January 2026
As part of its mission, the Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. The FDA also advances public health by helping to speed innovations that make medical products more effective, safer, and more affordable.
Title 21 CFR Part 11, originally released in 1997, set the standard for how regulated companies manage electronic records and signatures. In 2003, the FDA released additional guidance to clarify the scope and application of these regulations. For nearly two decades, these documents were the strict rulebook for Computer Software Validation (CSV) practitioners.
However, the technology landscape has shifted dramatically since those early codes were written. In the past, most IT systems were custom-built bespoke solutions. Today, most regulated companies choose configurable, off-the-shelf cloud solutions that adapt easily to their needs while minimizing costs.
The Challenges of Traditional CSV
Over time, it became apparent that the traditional CSV methodology, while functional, posed significant challenges. It produced massive amounts of documentation and testing overhead while often ignoring risk priority.
The old "test everything" approach consumed vast resources. Being a manual process, it was error-prone and often required multiple iterations due to documentation errors rather than actual software failures. Costs frequently escalated to 30-50% of overall project budgets.
Worse, traditional CSV was often perceived as a burden—a "check-the-box" activity to pass audits rather than a driver of quality. Companies would delay adopting new technologies to avoid the validation headache. In the era of modern cloud computing, where vendors push updates regularly, this resistance to change became a critical risk in itself.
The Arrival of Computer Software Assurance (CSA)
The industry has finally moved forward. The pivotal shift began with the FDA's release of the "Computer Software Assurance for Manufacturing, Operations and Quality System Software" (CSA) guidance. This marked the official transition from document-centric validation to critical thinking.
The transformation from Validation to Assurance encompasses changing the focus from documentation to critical thinking and the encouragement of automation. The emphasis is now on identifying critical items that actually impact product safety based on the intended use of the system.
Once high-risk items are identified, the impact of failure is assessed to determine necessary assurance activities. Only then are appropriate test steps compiled and documented. This risk-based approach has proven to deliver enormous time savings, financial benefits, and improved quality.
How Companies Have Successfully Transitioned
There is no longer any reason to wait. The guidance is established, and the benefits are proven.
Validify is a Salesforce partner with a unique application designed to streamline risk assessment, validation, and assurance activities for regulated companies. Validify was built for CSA, allowing companies to work according to modern guidance using a risk-based approach immediately.
Leveraging Validify comes with all the advantages of using a modern tool. The platform automates the agonizing validation activities that used to be manual. This saves time and money while producing consistent, high-quality deliverables.
Automating the Future of Compliance
Using Validify's automated tool eliminates deliberation on when to start a validation cycle. Every run takes minutes and identifies exactly what configuration changes were introduced. Whether it is a Salesforce update, an internal process, or a third-party application, we analyze and validate it instantly.
Why contact us today for a free trial?
Validify does not require any IT infrastructure apart from your existing Salesforce Org, as we offer a full SaaS model. The application can be installed in 10 minutes from the Salesforce AppExchange. No heavy services are required, and all training and support are handled remotely by our expert team.
The application will analyze your Salesforce org within minutes and immediately identify potential risks and mitigations. Upon approval, a set of validation documents will be created and ready for your review. All documents can be edited online, and the application will save any edits for the next run, removing the need to amend them again.
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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