Plasma Services Group Automates Donor Management and Facilitates Regulatory Compliance with IT Solutions' FileMaker Experts

Plasma Services Group (PSG) is a leader in the specialty antibody collection process for the medical diagnostic and pharmaceutical industries. By providing assay-specific data for their product, they are able to offer cost-effective methods for supplying biological materials for research, development, and manufacturing. With an unwavering commitment to understanding the individual requirements of suppliers and customers, the firm has established a relationship for quality and service that affirms the company’s role as a vital and valued partner for sourcing disease state plasma for the worldwide in vitro diagnostic (IVD) industry.

• When PSG opened its doors in 2004, company leadership selected Claris FileMaker as its database software. Over time, the implementation had expanded to five FileMaker databases, which were integrated to communicate with each other.
• Claris FileMaker also became integral in helping the firm maintain numerous certifications, including ISO-9001, Institutional Review Board, and FDA.
• PSG management was ready to make system upgrades but was also cognizant of the need for existing activities to continue seamlessly as part of the new solution.

PSG leadership was confident that IT Solutions would be the best choice to develop its FileMaker-based donor database, which would streamline operations and integrate with the firm’s new web portal, psgdonors.com.

• The donor database developed by IT Solutions eliminated the cumbersome task of collecting samples, calling donors, and conducting surveys by phone. Capturing this level of detail and data not only made the samples more valuable, but also reduced the associated labor, which was costly and time-consuming.
• The new donor database enabled the firm to automate the transmission of donor form information directly into the database. Once data was collected, PSG could qualify each prospective donor and track everything related to them, from their consent forms to their samples.
• As a provider of testing material to the medical diagnostics industry, PSG is required to maintain several certifications, including ISO-9001, Institutional Review Board, and FDA. The FileMaker database helped the firm track the data necessary for certifications related to its work.

• The FileMaker-based database not only provided important verification but also reduced donation processing time by enabling PSG to track donor processing effectively. This ensures that PSG can reconnect with donors in six to eight weeks and mitigates questioning about why the process took so long.
• With the FileMaker solution, PSG can also facilitate FDA approvals for its clients. Firms requesting clearance from the FDA must undergo a “premarket notification or 510(k) submission” — a long and intense process. PSG has become a valued partner in this effort, working with manufacturers to test the kits, provide samples, or both.
• The FileMaker database is enabling PSG to expand with the goal of becoming an all-encompassing resource for the diagnostic industry. The firm has created its own donor network with hundreds of people in the FileMaker database, specializing in those with autoimmune conditions. The database enables PSG to help other companies with diagnostic needs from start to finish; PSG provides the samples, helps clear their kits, validates them, and more.
• PSG has also leveraged FileMaker to manage work order routing and expedite the shipment process. PSG management can track when they received an order, when they committed to shipping it, and when it ultimately ships.