February 2026
Organizations operating in regulated industries such as life sciences, pharmaceuticals, and medical devices rely heavily on computerized systems to support critical processes. Ensuring these systems are compliant, reliable, and fit for the intended use is not optional. FDA computer system validation guidance defines how companies should structure validation activities, manage risk, and demonstrate ongoing control over systems that directly impact product quality and patient safety.
Why does regulatory validation of computerized systems still matter?
Computerized systems play a central role in manufacturing, quality management, laboratory operations, and data-driven decision making. Failures, misconfigurations, or uncontrolled changes can lead to compliance gaps, audit findings, and in severe cases, product recalls or patient risk.
Regulatory expectations are not limited to proving that a system works at go-live. They focus on maintaining confidence throughout the entire system life-cycle, including:
● Clear definition of the system’s intended use and regulatory impact
● Understanding how the system affects product quality and patient safety
● Controlled change management and documented release decisions
● Ongoing assurance of data integrity across system updates and integrations
When applied correctly, this approach shifts validation from a one-time activity to a continuous discipline that evolves alongside the system.
How does FDA computer system validation guidance align with modern risk-based thinking?
FDA computer system validation guidance has evolved alongside technology. Traditional validation models relied heavily on exhaustive documentation and manual testing, regardless of system complexity or risk. While thorough, this approach often created inefficiencies and slowed innovation, especially as cloud platforms, SaaS solutions, and agile development became standard.
To address this, the FDA promotes a risk-based mindset that prioritizes what truly matters. Systems and features that pose higher risk to patient safety or product quality require deeper testing and stronger controls. Lower-risk functionality can be validated using streamlined methods without compromising compliance. This shift allows organizations to focus effort where it delivers the most value.
FDA computer software assurance for production and quality system software
The introduction of Computer Software Assurance (CSA) represents a significant step forward for regulated companies. CSA encourages critical thinking, supplier leverage, and right-sized testing instead of checklist-driven validation. The goal is to ensure systems are fit for use, reliable, and well-controlled without generating unnecessary documentation.
Within this context, the FDA’s computer software assurance for production and quality system software provides practical direction for organizations that rely on computerized systems to support GxP activities. It reinforces the need to focus validation effort on critical functions, data integrity, and process impact, while allowing flexibility in how lower-risk functionality is assessed and documented.
This guidance clarifies expectations for systems that support core GxP processes. These include quality management systems, laboratory software, manufacturing execution systems, and other platforms that influence product release and compliance decisions.
In manufacturing environments, FDA computer software assurance for manufacturing and quality system software highlights the importance of assessing system impact on process control, traceability, and data integrity. Where software directly affects manufacturing outcomes, validation activities must be proportional to that risk.
What are the validation challenges in cloud and SaaS environments?
Cloud-based systems introduce new validation considerations. Frequent vendor updates, shared responsibility models, and limited access to underlying infrastructure require a different approach compared to on-premise systems. Organizations are expected to validate configuration, intended use, and business processes rather than the vendor’s source code.
Supplier assessment, review of vendor documentation, release impact analysis, and change management become critical components of compliance. Ongoing monitoring ensures that updates do not introduce unintended risk. These activities must be repeatable, traceable, and audit ready.
How can organizations build a sustainable validation operating model?
A sustainable validation model integrates compliance into daily operations. Risk assessments should be living documents that evolve alongside systems and processes. Validation activities should align with quality management, change control, and system governance rather than exist in isolation.
Organizations that succeed in this area typically rely on structured methodologies, standardized risk models, and automation to maintain consistency. Centralized documentation, clear traceability, and scalable processes reduce manual effort while improving inspection readiness.
Turning regulatory expectations into business advantage
Implementing regulatory validation requirements effectively requires more than interpretation. It demands practical execution, consistency across systems, and the ability to scale as technology evolves. This is where the right validation partner becomes critical.
Validify supports regulated organizations by translating regulatory expectations into efficient, risk-based validation workflows. Through automation, structured risk assessment, and intelligent documentation, Validify enables teams to adopt CSA principles without slowing innovation.
If your organization is looking to modernize validation, reduce manual effort, and stay aligned with evolving FDA expectations, Validify provides a clear path forward. With the right tools and expertise, compliance becomes not just a regulatory obligation, but a strategic advantage.
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.
Want to hear more or book a demo? Click here
