By Start Staff
Start Magazine
May 23, 2005

Government regulations are climbing the ladder of manufacturers’ priorities. But the burden is lessening as more and more respected software vendors are offering solutions designed specifically for the growing need for compliance.

In order to help manufacturers comply with the European Union’s (EU) Restriction of Hazardous Substances (RoHS) and Waste Electrical and Electronic Equipment (WEEE) measures, Omnify Software, www.omnifysoft.com, Wilmington, Mass., has released new solutions to help. According to the company, Omnify can help original-equipment manufacturers (OEMs) meet the regulations by providing a mechanism to identify parts that do or do not meet the guidelines, allow OEMs to easily export data into a bill of materials report for analysis of pass/fail parts, offer the ability to store all compliance declarations/certificates associated to a part, and finally, to properly maintain records of products in a “technical file” required by EU authorities.

A word of advice from Richard Paul, vice president of business development for Omnify, “While compliance with these regulations is crucial for companies in the electrical manufacturing industry, organizations should seek solutions that simultaneously provide opportunity to increase effectiveness in the overall product development process. Omnify’s solutions enable companies to meet the new standards set forth by the EU, while also increasing collaboration in the product development cycle and reducing costs and time spent on delivering products.”

Specifically for the life sciences industry, Rockwell Automation, www.rockwellautomation.com, Milwaukee, Wis., has introduced software designed to help OEMs minimize project risk, and accelerate system development while remaining compliant called OEM-specific Regulatory Compliance Services (RCS).

The services address compliance issues like system design consulting, computer system validation, protocol execution, qualification planning, risk assessments and audits, quality system consulting, 21 CFR Part 11 compliance, process analytical technology, electronic records management, and GMP training.

“Life sciences OEMs must have the knowledge, resources and application expertise to meet their customers’ unique application and regulatory requirements, including the ability to provide the tools, plans, and procedures to improve the efficiency and reliability of the customers’ complete system lifecycle,” says Gerhard Werling, manager of regulatory compliance services, Rockwell Automation.

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