An Introduction to Software Validation

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What is software validation and why is it important? Who does the validating and how is it accomplished?

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.

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 following deliverables document all validation activities and provide objective inspections 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 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.

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.

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.

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.

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