Validation Associates to Provide Technology Companies with Comprehensive Technical Analysis of Software Solutions for Compliance with 21 CFR Part 11

Validation Associates to Provide Technology Companies with Comprehensive Technical Analysis of Software Solutions for Compliance with 21 CFR Part 11

Raleigh, North Carolina, August 7, 2002 -- Validation Associates Inc. (VAI), a global provider of regulatory compliance services including 21 CFR Part 11 gap and remediation support, software and computer system validation, process validation, and vendors audits to life sciences companies, announced today the release of VAIs Part 11 Product Compliance Assessment offering. This new service utilized VAIs proven techniques and tool set provides technology providers a comprehensive gap assessment of their systems or applications to determine how well they have meet the technical and procedural requirements of 21 CFR Part 11 and GAMP.

21 CFR Part 11 compliance of new systems are critical issues for FDA-regulated companies," said Tuan Phan, President of Validation Associates. Life sciences companies want to purchase and use 'out-of-the-box Part 11-complied systems. Our innovative Part 11 Product Compliance Assessment service allows technology solution providers to build better products that comply with the requirements of 21 CFR Part 11. Not only will we assist our technology partners with the identification of the gap areas, we will also awareness training to design staff and provide remediation plan to close out the chasm." Some existing VAIs technology partners include Pilgrim Software, NotebookMaker, and Trusted Integration.

21 CFR Part 11 issues are not new to VAI. Since inception, the Company has been providing 21 CFR Part 11 related services to several of its clients and partners, including gap assessments, remediation plans, and vendor audits. In addition, VAIs professionals are active participants and presenter of industry seminars and conferences, and contributed to various industry magazines and journals. To explore partnership opportunities with VAI, please visit our web site, or contact us at 800-908-8230.
   
About Validation Associates
Validation Associates Inc. (VAI) provides regulatory compliance consulting services including 21 CFR Part 11 gap assessments, software and computer system validation, process validation, system and vendors audits, and strategic regulatory management to life sciences companies through its network of highly qualified consultants and industry experts. Validation Associates is headquartered in Raleigh, North Carolina.

On the Net: Validation Associates site: http://www.validationassociates.com