Validation Associates and Trusted Integration Collaborate to Deliver Cutting-Edge 21 CFR Part 11 Assessment and Remediation Project Management Tool

Validation Associates and Trusted Integration collaborate to deliver 21 CFR Part 11 Assessment and Remediation Project Management Tool to life sciences companies.

Raleigh, North Carolina, July 11, 2002 -- Validation Associates Inc., 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, today announced that the company has reached a consulting and marketing agreement with Trusted Integration, a provider of quality information security solutions in the area of GISRA compliance, security engineering, and security assessment and mitigation.

The agreement formalizes a joint development and marketing effort to bring forth a technology assessment and remediation project management tool, named 21 CFR Part 11 Analyst, to accelerate the implementation of 21 CFR Part 11 Compliance Initiative for small to mid-size life sciences companies. Validation Associates, whom already has extensive experience in the 21 CFR Part 11 arena, will be providing the analytical data required to perform the gap assessment and the remediation. Trusted Integration will be responsible for the technology tool development to be modeled from the companys successful product, the GISRA Compliance Tracker.

21 CFR Part 11 compliance of existing and new systems are critical issues for FDA-regulated companies," said Tuan Phan, President of Validation Associates. 21 CFR Part 11 Analyst will allow our life sciences customers to rapidly and cost-effectively implement 21 CFR Part 11 Compliance Initiative, in addition to the retention of 21 CFR Part 11 professional services from VAI."

Software licensing for the 21 CFR Part 11 Analyst tool will be based on a per system basis. Currently, 21 CFR Part 11 Analyst is only available to selected life sciences companies. VAI expects that the tool will be widely available at the start of the fourth quarter of 2002.

About Validation Associates, Inc.
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

About Trusted Integration, Inc.
Trusted Integration, Inc. provides quality information security solutions in the area of GISRA compliance, security engineering, and security assessment and mitigation. As a technology innovator, Trusted Integration has been setting benchmark standards in both government and commercial enterprises with practical solutions engineered through repeatable and automated methodologies.

On the Net: Trusted Integration site: http://www.trustedintegration.com