Back to:

Automation Portals

Rockwell Automation News

Rockwell Automation Successfully Completes PDA Pharmaceutical Industry Software Supplier Audit

Audit eliminates need for customers to conduct costly and time-consuming individual validations with Propack Data enterprise production management software

INTERPHEX, March 31, 2003 Rockwell Automation today announced that its Propack Data product and development systems and procedures have successfully passed the rigorous Parenteral Drug Association (PDA) pharmaceutical industry software supplier audit. Completion of the audit signifies that Rockwell Automation customers can now quickly and cost-effectively evaluate and implement Propack Data enterprise production management software.

Under FDA regulations, pharmaceutical, biotechnology and medical device manufacturers must select software suppliers that meet a predefined set of standards. During the audit, PDA examined the Propack Data software development lifecycle to verify that it uses documented quality management procedures, adequately tests software before release, and has sound support processes in place.

We always have been committed to delivering solutions that help our customers reduce the time-consuming and expensive measures needed to remain consistent with FDA standards, said Karl Linder, president, Propack Data. Our successful completion of this audit allows customers to realize these benefits while streamlining and accelerating their overall validation and procurement process.

Four PDA-qualified pharmaceutical companies, with experience and in-depth knowledge of regulatory procedures, jointly conducted the audit. The six-step process for PDA audit execution is outlined in PDA Technical Report #32. The report provides a standard method to assess the structural integrity of software and defines the framework for conducting audits. Prospective customers can easily access Propack Data audit results through the PDA Audit Repository Center.

PDA is a non-profit international association of more than 10,000 scientists and technologists involved in the development, manufacture, quality control and regulation of pharmaceuticals and related products. The association is a recognized source for global technical and regulatory information about the pharmaceutical industry. PDA also provides educational opportunities for government and university sectors that have a vocational interest in pharmaceutical sciences and technology.

Rockwell Automation (NYSE: ROK) is a world-leading provider of industrial automation power, control and information solutions that help customers meet their manufacturing productivity objectives. The company brings together leading brands in industrial automation for Complete Automation® solutions, including Allen-Bradley® controls and engineered services and Rockwell Software® factory management software, Dodge® mechanical power transmission products, and Reliance Electric® motors and drives. The company also is a leading provider of contact management technologies and applications that help companies more efficiently manage interaction with their own customers. Headquartered in Milwaukee, WI, USA, the company employs about 22,000 people in more than 80 countries.

For more information on the Propack Data completion of the PDA audit, please contact the Rockwell Automation Response Center, 10701 Hampshire Avenue South, Bloomington, Minn., 55438, 800.223.5354, Ext. 1614.

For more information, please visit www.rockwellautomation.com

Automation.com Real-time Information for the Automation Professional May. 25, 2012

Cart

Automation.com

NOTICE: Your use of Automation.com constitutes your agreement to the Legal Notices, Policies, Terms, and Conditions governing its use. You should review these terms before proceeding.Copyright © 2000-2010 Automation.com - automation.com, automationtechies.com, automationtechies, automationtechie, and Member-Match are all trade and service marks of Automation Resources, Inc. All Rights Reserved.