News

MasterControl Selects Epitome Technologies as International Partner

SALT LAKE CITY – Oct. 24, 2006 – MasterControl Inc. today announced that it has selected Epitome Technologies as a distributor of the MasterControl™ quality management software solution in India and the South Asian region.

Epitome Technologies, based in the city of Ahmedabad in Gujarat, India, provides consulting, engineering, and technology services, as well as software solutions to pharmaceutical and other industries. The firm's expertise includes Good Automated Manufacturing Practices (GAMP®) and the U.S. Food and Drug Administration's (FDA) 21 CFR Part 11.

The firm has a track record of successfully completing GAMP® projects involving top-notch pharmaceutical companies in India and has assisted clients in complying with regulations enforced by the FDA, Australia 's Therapeutic Goods Administration (TGA), the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA), and quality standards applied by the World Health Organization (WHO). It also assists clients with international audits for computerized systems validation.

?Epitome Technologies' expertise and its focus on customer satisfaction are very impressive,? said Greg Beeber, MasterControl's vice president, global alliances. ?We are confident that Epitome Technologies will help us gain a foothold in India, a powerful, emerging market for MasterControl.?

MasterControl launched its International Partnership Program last year to form strategic relationships with organizations that offer complementary products and services to diverse industries worldwide. In addition to Epitome Technologies, the program has attracted firms in the United Kingdom, Australia, 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, nonconformance 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.

About MasterControl Inc.
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 800-825-9117.

About Epitome Technologies Pvt. Ltd.
Epitome provides enterprise-wide technology and compliance solutions to regulated indus­tries in the life science sector. The firm delivers a comprehensive suite of computerized system validation, technology, regulatory, and business solutions and services. In addition to expertise in software validation, the team has the knowledge of U.S. FDA, MHRA, MCC, TGA regulations and the experience in applying best practices to help pharmaceutical companies meet their qual­ity and compliance goals methodically and cost-effectively. Epitome's professional services include GAMP® 4 based Computer System Validation (CSV), FDA's 21 CFR Part 11 compliance, integrated quality and compliance management solutions, and support for virtually all aspects of software testing. Epitome applies risk analysis throughout each engagement to establish practical priorities consistent with business objec­tives and regulatory guidelines. For more information please write to info@epitometech.com or visit www.epitometech.com .