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PRACS Institute, Leading CRO for Pharmaceutical and Biotech Companies, Chooses MasterControl™ to Boost FDA Compliance
SALT LAKE CITY Nov. 1, 2006 MasterControl Inc. today announced that PRACS Institute, Ltd., a leading contract research services organization for pharmaceutical, biotech, and skin-care companies, recently selected the MasterControl™ quality management suite to further strengthen its FDA compliance program and increase overall efficiency.
PRACS Institute, Ltd., based in Fargo, N.D., is a full-service CRO that offers in-house clinical trials, bioanalytical, pre-clinical dermatology, medical writing, and statistical research services in a variety of therapeutic areas. The 23-year-old company has research facilities in two states representing 17 study units. In late 2006, PRACS will add four more study units, which will increase the total in-house beds to 900. PRACS Institute, Ltd., is experienced in conducting all phases (Phase I-IV) of clinical trials for research studies involving prescription and non-prescription drugs, cosmetic, dermatology, and personal care products.
PRACS Institute, Ltd., research follows the guidelines of FDA regulations, which involve extensive document control requirements, ranging from protocol development to source documents, data documents, and final reports. "The company was looking to automate and improve its document revision and tracking process, as well as streamline staff training in addition to enhancing document control," said Rick Wanderi, associate director of Quality Assurance at PRACS Institute, Ltd. The company created a Document Control Task Force to evaluate different software applications. The Task Force narrowed the selection to four vendors before making a decision.
?The primary reasons we decided to go with MasterControl was the logic of the system and its adaptability,? said Wanderi. ?With a new program, you want people to be able to pick up and learn it quickly or they won't use it at all. MasterControl has a format and system that made sense to the task force. It also has the ability to adapt to the needs we have that might not be typical.?
PRACS Institute, Ltd. will be implementing the MasterControl quality management suite, consisting of:
Under the FDA's 21 CFR Part 11, companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems. MasterControl will provide PRACS Institute, Ltd. with IQ/OQ protocols and a Validation Toolkit, which includes SOPs, templates, and risk assessment forms, to facilitate validation of its system.
PRACS Institute, Ltd., which takes pride in its excellent track record in FDA audits, expects that MasterControl will optimize the company's quality management system and make it even easier to sustain compliance. ?In the end, we expect an efficient, cost-saving program that meets the requirements of the FDA,? said Wanderi.
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