KMI/PAREXEL Introduces GMPware Intelligent Software Tools

<%=company1%> (Belmont, MA) is pleased to announce the introduction of its GMPware Intelligent Software Tools. This suite of integrated software applications includes a validation protocol module (VPM), an engineering specification module (ESM) and a change control module (CCM). Created for industries that employ Good Manufacturing Practices (GMP) and Food and Drug Administration regulations, GMPware authors validation protocols and helps to organize, document, interrelate, share and control GMP specification information in one structured, visual database.

"This software has been needed by the industry for many years, " said Paul McKim, Director, KMI/PAREXEL and former FDA expert. "Finally, we have a series of software tools that can reduce the high costs associated with validation, change control and implementing the GMPs."

Each GMPware module is designed to operate independently or as part of an integrated product suite.

The VPM is the first and only database system that automates the generation of validation documents for the GMP industry using standardized validation methodologies and provides users with a clean and crisp way of managing corporate knowledge.

ESM collects all GMP specification information for a facility, its equipment systems and processes and organizes this information in an intuitive and logically structured database.

"GMPware has already begun to revolutionize the way regulated companies do business by reducing the cost to produce GMP documentation, standardizing complex methodologies, controlling and documenting the change process and easing the burdens associated with managing complex specification data," said Jon Voss, President, KMI Systems.

KMI/PAREXEL is a global compliance and validation services and technology company. A subsidiary of PAREXEL International Corporation, it has provided consulting and innovation to FDA-regulated companies for 10 years.

For more information, contact Pat Masterson at 617-484-9920, ext. 509.