2003-04 Premium Technology Providers Named By Audit Repository Center -ARC-.

Business Editors/High-Tech Writers

POTTSTOWN, Pa.--(BUSINESS WIRE)--Sept. 8, 2003

World Renowned Technology Companies Recognized for Most-Commonly Requested Product Audits In Compliance with FDA Regulations

A list of Premium Technology Providers(TM), including several of the most well-known and respected vendors, was released today by the Audit Repository Center. ARC is a unique clearing-house for standardized industry evaluations of commercial off-the-shelf (COTS) software and hardware products used by firms engaged in FDA-regulated industries.

According to Harvey Greenawalt, ARC President, "The ARC organization is pleased to announce that Agilent Technologies, Documentum, Inc., Fisher Rosemont Systems, MERANT, Inc., Mercury Interactive, and Sparta Systems, Inc. are 2003-04 Premium Technology Providers. Audits of their software and systems in compliance with FDA regulations, including 21 CFR Part 11, continue to be the most popular requested by ARC subscribers."

"Members of ARC," explained Mr. Greenawalt, "include Bristol-Meyers Squibb Company, Eli Lilly & Co., Novartis Pharmaceuticals Corporation, Pfizer, Schering-Plough and dozens of other leading pharmaceutical companies.

Pharmaceutical industry members now - at significantly reduced cost - can obtain this data for the computer services and products they use. The PDA Process repository administrated by ARC for PDA provides the means to share data collected in accordance with the industry standard process defined in PDA Technical Report #32 between and among participating companies.

About ARC and PDA

PDA - An International Association for Pharmaceutical Science and Technology -- has teamed up with ARC to provide the industry with audits that prove good evidence of the structural integrity of computer products and services used by the regulated industry. PDA Technical Report #32 (TR-32) "Auditing of suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations" (PDA Process) is designed to provide pharmaceutical and biotech companies with the maximum benefit of that verification using a global industry-endorsed program.

Benefits of ARC at-a-glance;

Subscribers to ARC Repository services report the following benefits:

-- 80% reduction in time to obtain and evaluate audit data

-- 50% reduction in cost of doing audit

-- 400% increase in number of audits that can be managed by a

single person

-- Enterprise-wide sharing of audit information

-- Standardization of method for analysis and consistent look and

feel to reports

-- Seamless integration with acquisition and existing System Life

Cycle practices

-- Fulfillment CFR Part 11 expectations of computer validation

and use of COTS products

-- Substantial reduction in employee travel

Participating Technology Providers benefit from:

-- Audits performed in an expedient, positive and professional

manner by experienced personnel

-- Data Collection Tool providing a clear and thorough

examination, probing the supplier's practices and determining

if they meet industry expectations

-- Time efficient method to reduce cost, satisfy regulatory

requirements and provide shareable data, reducing impact on

development

-- Reduced product cost to clients

-- Reduction of upfront cost to clients by eliminating

duplication; continuous improvement of the audit process

-- Secure environment for sharing audit data with pharmaceutical

and biotech clients

The Audit Repository Center is headquartered in Pottstown, PA, 19464; phone [phone]; fax [phone]; or www.auditcenter.com.

PDA is located at 3 Bethesda Metro Center, Suite 1500, Bethesda, MD 20814; phone [phone]; fax [phone]; or www.pda.org.