News

ICTI, Leading Clinical Trial Technology-Based Services Provider, Successfully Migrates to Web-based MasterControl™ Quality Management System

SALT LAKE CITY – April 18, 2006 – MasterControl today announced that Interactive Clinical Technologies Inc. (ICTI), a leading provider of technology-based services that help pharmaceutical companies accelerate clinical trials and improve data quality, has successfully migrated its quality management system from a client/server application to a Web-based MasterControl™ platform.

ICTI, a part of Almac Sciences, is based in Pennsylvania . Almac Sciences also has facilities in North Carolina, California, London, Edinburgh ( Scotland ), and Northern Ireland . A customer since 2002, ICTI switched to a Web-based MasterControl system to allow a global approach to quality management and to take advantage of the MasterControl Training™ module, an integrated part of the Web-based suite, according to Tom Barlow, QA audit manager at ICTI.

?We wanted a user-friendly document control system that would have global acceptance and we needed an effective training system to replace our manual process,? said Barlow.

Among ICTI's best-known products and services is the Interactive Voice Response Systems (iVRS), which enable real-time randomization in clinical trials, patient tracking, and clinical supply inventory management. ICTI solutions have been used in more than 80 countries and 750 clinical trials, spanning all clinical trial phases and all therapeutic areas.

ICTI migrated 24,000 documents to its Web-based MasterControl system within three days in February. ?The migration was very successful,? said Barlow. ?MasterControl was very responsive to any questions and issues we had.?

The company went live with MasterControl Training on Feb. 21. By integrating training control into its quality management system, ICTI is able to connect employees to any document and other changes that require training 24 hours a day, seven days a week.

MasterControl Training is a configurable, easy-to-use solution designed to effectively manage the training process and integrate it with other processes critical to FDA and ISO compliance, such as CAPA, change control, audit, and customer complaints. Its robust features include:

• Online Exams: Regulatory bodies are increasingly seeking proof of personnel competency through testing. This solution automates the assignment and follow-up of training tasks and even grading of online exams
• Training Curriculum: Allows development of a progressive training program through sequencing of training courses. As soon as a trainee completes a prerequisite, the next course is automatically launched.
• Group Sign Off : For companies with hundreds of employees being trained at once, verifying and signing off for each trainee can be time-consuming. With this feature, the course instructor or verifier can sign off once for large groups of trainees.
• Revision Control: Automatic revision control ensures that only current version of training courses are available to users.
• Advanced Analytics and Reporting: Automatically performs gap analysis for all training tasks ? all the time.

ICTI, which complies with stringent FDA regulations, validated its new software system as required by 21 CFR Part 11. MasterControl assisted in the validation process, providing IQ and OQ protocols.

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 quality standards such as ISO 9000, ISO 13485, 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.