SALT LAKE CITY - August 1, 2005 ?MasterControl Inc. today announced that the Institute for Transfusion Medicine (ITxM) has gone live with MasterControl quality suite as part of its FDA compliance initiative and to help ensure the safety of its blood supply.
ITxM, based in Pittsburgh , consists of two blood banks, a diagnostic center, a network of transfusion centers, and a consulting group. ITxM's Central Blood Bank distributes more than 400,000 blood products to over 40 hospitals in western Pennsylvania and northern West Virginia . LifeSource Blood Services, also owned by ITxM, distributes more than 750,000 blood products, operates 22 community donor centers, and provides services to 94 percent of Chicago-area hospitals.
"Document control is extremely critical for us. We must ensure that every employee is using the correct documents at all times, and this is where MasterControl can really help us," said Roxanne Tata, vice president and chief quality officer of ITxM.
Previously, ITxM used paper-based processes and a server to store electronic documents in directories. The organization wanted a fully automated system to increase efficiency, implement the use of electronic signatures for document review and approvals, and maintain regulatory compliance. ITxM evaluated and reviewed three software providers and conducted a pre-selection audit of MasterControl's operations in its Salt Lake City headquarters before making a decision. ?We chose MasterControl because it best suits our needs, in terms of features, functionality, and cost,? said Tata.
The two blood centers were the first to use MasterControl, going live on July 8. Approximately 900 of the organization's 1,250 employees will be using MasterControl when full deployment takes place later this year.
"The mission of the blood industry hits home to many of our employees and employees' families. It is easy to understand the critical need for quality in blood products and MasterControl is proud to support the great team at ITxM in its worthwhile mission,? said Jon Beckstrand, CEO of MasterControl.
ITxM complies with strict FDA regulations such as 21 CFR Parts 11, 210, and 600. With MasterControl Documents, the core application within the MasterControl suite, the organization ensures compliance by managing thousands of documents in a secure and centralized repository, using a 100 percent Web-based platform that gives access to employees, vendors, and customers from virtually anywhere.
MasterControl provides advanced routing, approval, reporting, and version control. It maintains a time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record, when the action occurred, and the changes made to the record.
MasterControl also conducted onsite qualification tests for ITxM, including IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) for a full validation of the system as required by Part 11.
About MasterControl Inc.
MasterControl has been at the forefront of providing innovative electronic quality management systems since 1993. It provides a configurable, easy-to-use, and integrated system to help companies effectively manage change control, training control, audits, corrective/preventive action (CAPA), and other forms-based quality processes under a single Web-based platform. MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. More than 400 companies worldwide use MasterControl to consistently meet FDA regulatory requirements and industry quality standards, including ISO and QS/TS. For more information, visit www.mastercontrol.com , or call 800-825-9117.