SALT LAKE CITY — Sept. 5, 2006 — MasterControl Inc. today announced that it has selected PharmOut, a leading Australian consulting firm for pharmaceutical, veterinary, and medical device industries, as a distributor of the MasterControl™ quality management software solution in Australia, New Zealand, and the Pacific region.
“PharmOut and MasterControl share a common goal: to provide the very best quality management solution to regulated industries,” said Greg Beeber, MasterControl’s vice president, global alliances. “The Australian market offers tremendous opportunities, and we’re excited about this partnership. PharmOut has the expertise to carry out full implementation of a MasterControl project.”
PharmOut, based in Melbourne, Australia, caters to multinational companies in the region. Its clients include GlaxoSmithKline, Mayne Pharma, and Chemeq. The firm offers best-practice solutions in the areas of Good Manufacturing Practice (GMP), regulatory, validation, and process improvement for companies seeking compliance with regulations enforced by the U.S. Food and Drug Administration (FDA), European Agency for the Evaluation of Medicinal Products (EMEA), Australia’s Therapeutic Goods Administration (TGA), and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).
“MasterControl meets the needs of both large and small pharmaceutical and biotech companies. Its modular approach allows them to implement a document control solution on a budget that can be expanded to meet changing requirements,” said Trevor Schoerie, PharmOut’s managing director. “Even in Australia, the MasterControl brand is well-known. It lends credibility to our complete offering.”
MasterControl launched its International Partnership Program last year to form strategic partnerships with organizations that offer complementary products and services to diverse industries worldwide. In addition to PharmOut, the program has attracted firms based in the United Kingdom, the Netherlands, and Israel.
The MasterControl quality management suite is a configurable, easy-to-use, and off-the-shelf software solution that helps companies attain “continuous compliance” with FDA regulations, ISO standards, Sarbanes-Oxley Act, and other regulatory requirements. MasterControl automates and effectively manages document and change control, training, audits, corrective/preventive action (CAPA), customer complaints, non-conformance disposition, and other quality processes.
For FDA-regulated companies, MasterControl offers a “continuous validation” approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl’s line of validation products and services address different levels of needs based on individual risk assessment. They are designed to make validation of software upgrades easier, faster, and more cost-effective.
MasterControl Inc. has been at the forefront of providing quality management software solutions since 1993. Hundreds of companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-211, 820, 606; ISO standards such as ISO 9000, ISO 13485, and ISO 14000; and Sarbanes-Oxley Act requirements. 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 www.mastercontrol.com, or call +1 800-825-9117.
PharmOut is an Australian firm consulting to the pharmaceutical, veterinary, and medical device industries. It offers best practice solutions for complex quality or GMP, regulatory, validation and process improvement problems. For more information call 03 86 400 933.
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