News

Community Blood Center of the Carolinas Selects MasterControl™ Quality Management Software Suite

SALT LAKE CITY – May 15, 2006 – MasterControl Inc. today announced that Community Blood Center of the Carolinas (CBCC), an independent, nonprofit organization, has selected the MasterControl™ quality management suite to facilitate FDA compliance and enhance efficiency.

CBCC supplies blood and blood products to 14 hospitals serving residents in 11 North Carolina counties and three South Carolina counties. The center, based in Charlotte, N.C., emphasizes regulatory compliance and quality assurance standards in its organizational mission.

CBCC was looking for a quality management solution with powerful document management, revision control, and training control features. The center needed a solution that will accurately capture the history of document revisions as well as employee training requirements and competency, said Beth Kinard, director of operations at CBCC. The center chose MasterControl over four other software providers.

Kinard said MasterControl's competitive edge included reasonable pricing, robust functionality, good reputation, and positive comments by other users. ?We also were able to do an onsite visit and see the program in action,? said Kinard, referring to CBCC's pre-selection audit of MasterControl's operations in its Salt Lake City headquarters.

Blood establishments are covered by the FDA's Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Parts 606 and 210-211. The center will be implementing a fully integrated MasterControl suite, consisting of:

 

  • MasterControl Documents™ ? The essential building block within the MasterControl suite, this application manages and controls documents in a secure environment. It automates task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. Document types, vaults, lifecycles, routes, and users' roles are all configurable.
  • MasterControl Forms™ ? This module automates forms-based processes, such as audits, nonconformances, deviations, and customer complaints. It makes the transition from a manual/hybrid system to an automated solution easy because it allows users to create electronic forms identical to their existing hard-copy forms. Companies can also design new forms to suit their needs.
  • MasterControl Training™ ? This software automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. It also provides group sign-off feature for verifying training of large groups of employees. Training control can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

 

CBCC expects to strengthen its compliance and accreditation efforts and foster efficiency with the help of MasterControl, said Kinard. The center is accredited by the American Association of Blood Banks (AABB), an international group that promotes the highest standards for blood establishments.

Under 21 CFR Part 11, FDA-regulated companies such as CBCC, which choose to maintain electronic records to meet predicate rules, are required to validate their electronic record-keeping systems. MasterControl will provide IQ and OQ protocols and a Validation Toolkit, which includes SOPs, templates, and risk assessment forms, to facilitate the center's validation efforts.

About MasterControl Inc.
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. MasterControl provides a configurable, easy-to-use, and integrated system to help companies effectively manage document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other forms-based quality processes under a single Web-based platform. It offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. For more information, visit www.mastercontrol.com, or call 800-825-9117.