SWAT helps companies navigate the complex world of FDA Validation.
FDA compliance is critical to the success of regulated companies. All software used in conjunction with a Quality System must be validated per regulations such as 21 CFR Part 11 and Part 820.
Independence of Review
The FDA suggests that validation activities, especially for higher risk applications, be conducted by an independent party. SWAT helps companies by being that trusted independent resource.
Internal or external audits may expose compliance gaps that require validation efforts. SWAT helps companies with both preventative validation as well as remediation and corrective actions.
What We Do
SWAT Solutions can help you assess risk and conduct validation planning to minimize the overall effort while ensuring the software meets the intended use and detailed requirements.
Our team will provide you expert planning services to effectively and comprehensively verify and validate a variety of requirement types. We have extensive experience gathering and documenting Installation, data migration, functional, performance requirements, and more.
Protocol Development & Execution
Test protocol development and execution is the bulk of the work. Our teams design, document and execute test protocols that enable compliant results and summary reports that prove your application has been validated.
Results & Reporting
Detailed reports with objective evidence will be organized to easily trace tests with expected results to requirements and indicate any failures that were encountered. Summary reports reconcile the validation plan.
How We Help
SWAT has been conducting FDA software validation activities/projects since our inception in 1997. With a strong presence in the medical device industry over the years, SWAT has the knowledge and tools to get the job done right.
SWAT has FDA software validation templates that can be tailored to your project’s needs including Master Validation Plan (MVP), Validation Plan (VP), Risk Assessment, User Requirements Specification (URS), Functional Requirements Specification (FRS), Test Protocols, Requirements Traceability Matrix (RTM), Validation Reports, and Summary Validation Report (SVR).
SWAT handles Validation projects of all sizes. From a single on-site resource to multiple off-site resources our team can scale to meet your validation project needs.