FDANews

BloodSource Taps MasterControl Software for Part 11 Compliance

BloodSource, a regional nonprofit community blood center serving 39 hospitals in 25 counties in northern and central California, has chosen the MasterControl quality management suite to facilitate FDA compliance, foster efficiency, and increase effectiveness, MasterControl announced last month.

BloodSource has a history of innovation in blood transfusion therapies and scientific advancements. Its human leukocyte antigen (HLA) laboratory is one of the most highly acclaimed in the world, and its reference laboratory is one of only 50 accredited laboratories in the U.S. to handle complex blood compatibility testing for patients.

Blood establishments depend heavily on paper forms to comply with FDA regulations. Automating and streamlining the document-control process was a main concern for BloodSource, which is covered by FDA 21 CFR Parts 606, 210–211, and 11. “We believe that control of the physical paper and control of the information on that paper — its integrity — could be managed effectively by an electronic document control system,” said Bill Collard, project consultant for BloodSource.

Collard said BloodSource chose MasterControl based on the product’s maturity and stability, overall functionality, and cost effectiveness; and the vendor’s ability to serve as a partner.