ValGenesis opened a new avenue of opportunity with a leading Plasma based product company that has implemented the paperless Validation Lifecycle Management System (VLMS) into their plasma donor collection centers.
The Blood Services industry must ensure compliance with several agencies including the Food & Drug Administration, (FDA), the Center for Biologics Evaluation and Research (CBER), and the American Association of Blood Banks (AABB). The FDA has recently enhanced their enforcement by putting stricter requirements in place, such as inspecting facilities every 2 years, as well as ordering recall or legal action. ValGenesis’s FDA Compliance Validation Lifecycle Management Software solution fully complies with the FDA and other regulations such as 21 CFR Part 606, 21 CFR Part 11, 21 CFR 211.68, 211.100(a), 606.100(b) (15), 606.160(b)(5)).
ValGenesis VLMS supports all types of validation processes related to the plasma donation centers, as it provides centralized validation lifecycle management, workflow management, and reporting for all critical business processes. By consolidating redundant systems, eliminating paper based manual operations, and implementing best-of-breed technology, ValGenesis enables blood banks to achieve “best in class” results. Further, ValGenesis ensures that data created, modified and stored within the application is capable of withstanding internal and regulatory audits while improving the overall efficiency of the validation program.
“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,” commented Narayan Raj, Vice President of ValGenesis Inc. “ValGenesis enables Blood organizations to efficiently manage the validation process and enforce current good documentation practices (cGDP), organizational SOPs and compliance guidelines from regulatory agencies and industry associations such as the AABB. We are very pleased to offer our Validation Lifecycle Management system to such an esteemed organization that must meet stringent validation requirements in the blood industry.