Software Tool Validation
With software continuing to drive incredible advancements in MedTech, device regulations are placing more emphasis on the management of software tools. We will help you understand the implications for your business with a customized roadmap designed to take you through the validation process, successfully.
TOOL VALIDATION IN SAFETY-CRITICAL AREAS
With regulatory scrutiny now extending beyond the end product and its development processes to the tools used during the development life cycle, software tool validation is critical to both your development process and overall business. How are you preparing to demonstrate and document that the software tools meet the guidelines for compliance and quality management? We offer a proven framework for software tool validation that removes doubt and uncertainty and ensures you are well prepared.
Tool validation plan
Starting with the who, what and where of the validation project, we develop a comprehensive plan that documents and describes the critical components of the validation effort: intended use, software features included in the planned use cases, test environment, tool validation methods, and specific testing procedures. A risk analysis is performed on each tool relative to its intended
use to identify and assess potential hazards that could impact product
quality and safety.
Adhering to proven processes, the validation test procedures we create outline each tool’s capabilities (and limitations) relative to their impact on the product under development. Test plans include test cases for each tool that focus on the critical functions that can affect product quality and safety, expected results, and assumptions.
Guided by a comprehensive test plan, we run the test protocol and document all test results, including successes, errors, and failures.
TOOL VALIDATION REPORT
All evidence of the execution of the validation protocol is methodically captured in a comprehensive tool validation report that becomes part of the design history file.
SOFTWARE TOOL VALIDATION
A COST OF DOING BUSINESS IN HIGHLY REGULATED ENVIRONMENTS
Our technical know-how, industry expertise, and extensive knowledge of relevant FDA regulations makes us uniquely qualified to develop a comprehensive tool validation plan for your next development effort. By including tool validation in project plans, you will achieve an overall validation process that is easier to manage. And it may even help accelerate regulatory approval.