Summary
Software validation is how an FDA-regulated organization demonstrates and documents that a software product fulfills its intended use and meets the user's software requirement specifications. This article walks through USDM's structured validation approach for customers: defining user specifications and intended use, performing a risk assessment, producing the core validation deliverables, executing IQ/OQ/PQ testing, and maintaining the validated state after go-live.
What Is Software Validation and Why Is It Important?
Software validation is the process of evaluating a software product to ensure that it fulfills its intended purpose and that it meets the software requirement specifications (SRS) of the user. Similarly, FDA software validation is when an FDA-regulated company demonstrates and documents that their software can accurately and consistently produce results that meet predetermined guidelines for compliance and quality management. In this blog, we will address end-user validation requirements.
For FDA-regulated companies, validation is also foundational to electronic records and electronic signatures. A validated system is a prerequisite for demonstrating 21 CFR Part 11 compliance, where the trustworthiness and integrity of records depend on a system that has been shown to work as intended.
Who does the validating, and how is it accomplished? Validation is a collaboration between trained validation personnel and the customer's subject matter experts. It is accomplished through documented, objective evidence — specifications, risk assessments, test scripts, and a traceability matrix — that confirms the software performs reliably across all anticipated situations.
USDM's Approach for Customers
USDM's approach to software validation starts with defining user specifications and the software's intended use. We can then move on to the risk assessment to determine if the product is appropriate for the customer's needs.
USDM's validation plan document defines what will be validated and the approach to be used. It also defines roles and responsibilities along with the most important aspect, which is the acceptance criteria.
The acceptance criteria are the most important aspect of the validation plan — they define, in advance, what "working as intended" actually means.
The following deliverables document all validation activities and provide objective inspection evidence to confirm that the software will work in all anticipated situations.
- User Requirements Specification (URS) and Functional Requirements Specification (FRS)
- Risk Assessment
- Architectural Design Specification
- Configuration and Design Specification
Validation personnel and the customers are consulted during the requirements and configuration phases. During this time, validation personnel can begin preparing and planning for the validation testing. Once a full development environment has been set up, the validation team can engage directly in preparing the required validation documentation. The documentation produced in this phase typically includes:
- Installation Qualification
- Operational Qualification / Performance Qualification (user acceptance testing of software)
- Scripts: How to go about the qualification (test scripts)
- Traceability Matrix: Ensure specs are listed, accounted for, and verified
- Summary Report: Summarizes the testing results and provides confirmation that all acceptance criteria have been met and the software is ready for deployment
The Software Validation Lifecycle at a Glance
- Define — Capture user specifications and the software's intended use (URS/FRS).
- Assess — Perform a risk assessment to confirm the product fits the customer's needs.
- Plan — Author the validation plan: scope, approach, roles, responsibilities, and acceptance criteria.
- Specify & Design — Produce architectural, configuration, and design specifications.
- Test — Execute IQ/OQ/PQ with test scripts; record all results and any deviations.
- Approve — Sign and approve all documentation; summarize results against acceptance criteria.
- Maintain — Train users, implement SOPs, release the system, and keep it in a validated state.
The test scripts record all results and deviations (if any). On completion of the validation process within the validation environment, all documentation is signed and approved by the stakeholders.
Provided there are no deviations or exceptions that violate compliance regulations, the production environment can be installed and qualified.
Learn more about USDM's Computer Software Validation and Computer Software Assurance methodologies. For teams managing many systems, a programmatic view of validation lifecycle management helps keep deliverables consistent and audit-ready across the portfolio.
After the Validation Is Complete
When the software validation is complete, we assist with data migration and validation of spreadsheets, if needed. After the system has been accepted, customers are trained for daily operations. Along with training, guidance for the related SOPs implementation and official release of the system is provided.
Because data migration and ongoing operations directly affect record trustworthiness, validation activities should reinforce data integrity throughout the system's lifecycle — not just at go-live.
Additionally, we can maintain the validated state of any system or SaaS application with our proprietary Cloud Assurance subscription that ensures continuous GxP readiness.
The USDM Life Sciences assessment methodology is extensive and we can help you assess, plan, and execute the changes and enhancements necessary to meet global regulations for your preferred methodology – CSV or CSA. To learn more about the FDA's upcoming Computer Software Assurance guidance, watch our on-demand webinar with the FDA or read our recent white paper.
As organizations introduce automation and AI into validated environments, the same evidence-based discipline applies. Extending established AI governance and compliance practices to new technologies keeps innovation within a controlled, auditable framework.
FAQ: Software Validation
What is software validation?
Software validation is the process of evaluating a software product to ensure it fulfills its intended purpose and meets the user's software requirement specifications (SRS). For FDA-regulated companies, it means demonstrating and documenting that the software can accurately and consistently produce results that meet predetermined guidelines for compliance and quality management.
What are the core validation deliverables?
Key deliverables include the User Requirements Specification (URS) and Functional Requirements Specification (FRS), a Risk Assessment, an Architectural Design Specification, and a Configuration and Design Specification. Testing then produces Installation Qualification, Operational/Performance Qualification, test scripts, a traceability matrix, and a summary report.
What is the role of acceptance criteria in the validation plan?
Acceptance criteria are the most important aspect of the validation plan. They define, in advance, what successful performance looks like, so that test results can be objectively measured against a predetermined standard before the software is approved for deployment.
What happens after validation is complete?
Once validation is complete, USDM assists with data migration and spreadsheet validation if needed, trains customers for daily operations, provides guidance on related SOP implementation, and supports the official release of the system. The validated state can then be maintained over time, including for SaaS applications.
How is the validated state maintained over time?
The validated state of any system or SaaS application can be maintained through USDM's proprietary Cloud Assurance subscription, which is designed to ensure continuous GxP readiness as systems, vendors, and regulations evolve.
Ready to Validate with Confidence?
Whether you are validating a new system, migrating data, or maintaining a validated state across your portfolio, USDM can help you assess, plan, and execute under your preferred methodology. Contact USDM to talk through your software validation needs.
About the Author
Najiba Baig is a Validation Engineer at USDM Life Sciences. She has worked in the pharmaceutical and biotech industry for several years in validation roles.