ValGenesis, Fremont, Calif, has implemented a paperless validation life cycle management system within the company’s software application for plasma collection centers.
Companies in the blood services industry must ensure that their operations are in compliance with standards and regulations established by several agencies, including the American Association of Blood Banks (AABB), and the FDA Center for Biologics Evaluation and Research. FDA has recently enhanced its enforcement activities by putting in place stricter requirements—such as inspecting facilities every 2 years—as well as by ordering recalls and taking legal actions.
The ValGenesis system supports all types of validation processes related to plasma donation centers, as it provides centralized validation life cycle management, workflow management, and reporting for critical business processes. By consolidating redundant systems and eliminating paper-based manual operations, ValGenesis enables blood banks to achieve ‘best in class’ results. Further, ValGenesis ensures that data created, modified, and stored within the application are capable of passing internal and regulatory audits while improving the overall efficiency of the validation program.
Narayan Raj, ValGenesis.
“The blood industry is continuously growing, and our new customer focuses on maintaining quality in all of its donation centers, for which validation is a critical aspect,” says Narayan Raj, vice president of ValGenesis Inc. “ValGenesis enables blood organizations to efficiently manage the validation process and enforce current good documentation practices, organizational standard operating procedures, and compliance guidelines from regulatory agencies and industry associations such as AABB. We are very pleased to offer our validation life cycle management system to organizations that must meet stringent validation requirements in the blood industry.”
For more information, visit ValGenesis.
