GMP/QSR design control, parexel methodology, medical device validation, valpro intelligent protocol software, regulatory compliance, product lifecycle

KMI provides the highest quality compliance and validation services reflecting the most current technology and a thorough understanding of FDA's GMP requirements. This has been the foundation of our rapid growth. Now the largest compliance and validation services company in the world, KMI has clients throughout the United States, Puerto Rico, Canada, Europe, Mexico, Africa, and Japan. Kemper-Masterson, Inc. (KMI) was founded by Dr. Clarence A. Kemper and P.Michael Masterson to address the validation requirements of computer-controlled processes in FDA-regulated pharmaceutical, biotechnology, and medical devices industries. Subsequently, they added a GMP Compliance Consulting group under the leadership of Dr. Ronald Tetzlaff, who is now President of the Company.

Today, KMI is recognized worldwide as the leader in validating computer-controlled GMP, GCP, and GLP processes, and as the only firm having both an outstanding GMP Compliance Consulting group of experts with prior FDA experience and a strong Validation Services group of experienced process and software engineers. KMI merged with PAREXEL International Corporation, LLC, in December, 1997. PAREXEL is a global contract research organization. Serving the pharmaceutical, biotechnology, medical device, and diagnostic industries, PAREXEL designs and manages worldwide, multi-site clinical trials required for regulatory approval and product marketing support. Consulting Services at KMI include Validation Services Consulting, Compliance Services Consulting, Information Systems Consulting and Quality Systems Services Consulting. Project Plan Development, Project Planning, Protocol Development, Project Implementation and Scheduling/Administration for all aspects of the validation effort, including Cleaning Validation, are among the services provided for regulated industries. Prior to joining the company, most of our Compliance Consultants were FDA experts in various disciplines, such as bulk pharmaceutical chemicals, sterilization, medical devices, computer systems compliance and enforcement procedures. We are qualified to address and evaluate compliance issues in FDA-regulated companies; and to monitor international and GMP/QSR standards, track inspection methods and tactics and implement this knowledge for our clients.

The Information Systems Consulting Group is the leading source of effective and efficient Computerized System Validation, Software Quality Assurance and Compliance Consulting Services for FDA-regulated industries and Computerized System suppliers. Our 21 CFR Part 11 Compliance Methodology helps clients sustain a compliant and high-quality regulatory environment. The evolving Quality System Regulations (QSR) and increased FDA enforcement have often required companies to utilize professional consulting services to augment their organization's skills and expertise. We believe substantial QSR compliance is achieved through dynamic integration of Good Engineering Practices, Quality System Programs and Quality Engineering Methodology. Also, throughout the drug/device industry, GMPware tools developed by KMI Systems are being used. These tools automate processes and provide productivity tools for engineers.

Finally, KMI specializes in developing and presenting in-house CGMP training programs for personnel within the pharmaceutical, biopharmaceutical and medical device industries that address various GMP/Quality System Regulation (QSR) compliance, Quality Systems and validation-related issues. The course materials are specifically designed to aid personnel in understanding the regulatory requirements of FDA, current industry standards and the integration of these requirements and standards into associated Quality Systems Programs.