Blood Bank system validation is required, and enforced, by the FDA. The FDA regards Blood Bank systems as critical medical devices that can have real and substantial safety risks if not managed with the highest quality standards.
The FDA requires significant levels of validation testing and test documentation in order to clearly demonstrate “patient safe” results from interactions with Blood Bank systems. The agency has published clear guidelines to help organizations that are striving to comply with Blood Bank system regulations.
In order to comply with the FDA, healthcare organizations must meet the following requirements:
- perform a risk assessment
- test and assure correctly defined system security
- test and validate all interfaces – including HIS and LIS.
- Validate the output of system reports
- create and maintain a validation report – including summary test results, including variances, failed tests, amendments to test cases, outcome evaluation, sign-offs and approvals by management
- Validate after changes – perform regression testing to ensure changes and system still function as intended
Validating systems to meet these requirements is time consuming and resource-intensive. Many healthcare organizations struggle with the task of achieving thorough validation while maintaining system availability with the lowest possible risk. TestStream leverages decades of healthcare industry experience to provide the comprehensive testing by enabling you to:
- understand all the configuration variables and code or database changes
- evaluate ALL patient/product compatability and Interpretations interaction permutations for every validation
- utilize our Scenario solutions to provide detailed typical patient workflow journeys throught the applications
- implement Scenario solutions to validate worst-case, requirements-based patient and product journeys throughout the applications
- produce screen image captures for every significant validation workflow step
- provide digital signature support for test results review
- leverage built-in error analysis and risk-assessment tools to quickly and easily prepare your systems for production
- provide detailed reports, mapping validation test results to requirements
Once initial testing and validation is completed, organizations can continue to take advantage of TestStream’s powerful capabilities in an ongoing basis for patch management regression testing as well as re-testing and re-validation cycles, all at a fraction of the cost of any other option.
If you are faced with the challenge of meeting FDA system requirements, contact us today to learn more about how Vedant can help you achieve compliance in a fraction of the time and cost of any other option.
Visit our resources page to learn more.