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Xcellerex Selects MasterControl to Facilitate 21 CFR 11 and CGMP Compliance and Support Mission of Accelerating Development of Cutting-Edge Pharmaceuticals

Jun 28, 2017, 20:45 PM by System


Xcellerex Selects MasterControl™ to Facilitate 21 CFR 11 and CGMP Compliance and Support Mission of Accelerating Development of Cutting-Edge Pharmaceuticals

SALT LAKE CITY – July 5, 2005 – MasterControl Inc. today announced that Xcellerex, a leader in the cutting-edge field of biopharmaceutical development and manufacturing, has chosen MasterControl™ quality suite to facilitate FDA compliance and help achieve its overall mission of accelerating the process of bringing life-saving medicines to patients.

Xcellerex, based in Marlborough, Mass., offers contract services for bioprocess development and manufacturing. Process development services include the full range of process optimization activities using the PDMax? platform, manufacturing using the FlexFactory? platform, as well as GMP cell banking, management of cell line testing and assistance with preparation of documentation for IND or other regulatory filings.

?With a primary mission of speeding up delivery of medicines to people through high throughput process development tools and manufacturing systems, Xcellerex recognized MasterControl's numerous features as a complementary application that would further enable our company to execute our business and its mission,? said Michael Fisher, vice president for operations

Xcellerex chose MasterControl because it provided all the features the company was looking for, said Fisher, such as:

  • Security and 21 CFR 11-compliant capabilities
  • Rapid configurability
  • Clean user interface
  • Flexibility to suit multiple department needs and document types
  • Web-based remote access for better customer involvement

?MasterControl offered all of the functionality we desired and also possessed the infrastructure to meet the quality, validation, training, and technical support needs that we have,? said Fisher. He also noted the thoroughness of the product training provided by MasterControl's Professional Services Team, which greatly enhanced the ability of Xcellerex to install and deploy MasterControl rapidly and effectively.

Xcellerex, which conforms to stringent FDA requirements such as Current Good Manufacturing Practices (CGMP) and other quality standards applied by the European Union and World Health Organization, uses MasterControl throughout the organization. In May, Xcellerex received the 2005 Technology of the Year Award in Biologics Manufacturing from the global consulting firm Frost and Sullivan.

?We are excited to partner with Xcellerex in its quest to speed medicines to people. MasterControl has been developed for quick deployment and ease of use ? it will be very effective in helping Xcellerex improve the speed and quality of process development and quality control. We are committed to make sure that MasterControl supports Xcellerex customers' needs,? said Jon Beckstrand, CEO of MasterControl .

About MasterControl Inc.
MasterControl Inc. has been at the forefront of providing quality management software solutions since 1993. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, implementation, and validation services. For more information, visit, or call 800-825-9117.


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