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:

  • MasterControl Documents? ? 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. MasterControl tracks all document changes and provides automatic revision control to ensure that only the current version of a document is available. This core application integrates other quality processes such as training control, change control, customer complaints, corrective/preventive action, and audits for a closed-loop solution.
  • MasterControl Forms? ? Automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. This solution offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs. MasterControl is Web-based, so employees, customers, suppliers, and others can participate in forms-based processes from virtually anywhere.
  • MasterControl Training? ? 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 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.

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.

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, or call 800-825-9117.