LAKE FOREST, Calif., March 5, 2002 – Wonderware, an operating unit of the Production Management Division of Invensys plc, today announced that the company has reaffirmed its commitment to meet the needs of regulated industries that must comply with U.S. Food & Drug Administration (FDA) requirements, specifically 21 CFR Part 11. Several major product and support initiatives will soon be underway from the California-based software developer.
"Historically, Wonderware has always been a leader in providing enabling software tools for implementing FDA validated applications," stated John Nichols, senior vice president/general manager for Wonderware. "In 1995, with our InBatch™ product, we added a Security Manager which was developed in coordination with our customers in the food and pharmaceutical industries. Two years later, 21 CFR Part 11 was issued and our InBatch product was already capable of meeting the regulation requirements.
"This past year, we had a major release of our flagship product, InTouch® software version 7.11, which introduced significant new enhancements to alarm logging and the ability to configure runtime audit trails. With our new InBatch 8.0 product, we continue to add value with enhancements to the Security Manager and by adding recipe security with verified writes and 'Checked By' designations.
"In 2002, we continue that tradition with upcoming major enhancements for FDA validation in our InTouch, InBatch, and IndustrialSQL Server™ products," he said. This commitment also includes the development of applications and tools to help the regulated industries achieve and maintain compliance with 21 CFR Part 11 with minimum life cycle costs, Nichols said.
One of the key elements of working in the FDA-audited environment is that producers want to maximize their project lifecycles. If users can enhance and improve their applications while reducing the amount of new validation work, then they can save a lot of money. The product improvements that Wonderware has been working on are focused on lowering the implementation and maintenance costs of FDA-validated applications.
To support its customers, Wonderware plans to launch a full-fledged FDA resource center on its website to offer assistance on how Wonderware products can be applied and deployed in implementing and maintaining 21 CFR Part 11 validated applications, third party supporting tools, and general FDA links to validation companies serving the market. "As our products evolve, this area will be continually reviewed for improvement. We are dedicated to making FactorySuite® tools the most sophisticated and easiest to use, all while reducing development and lifecycle costs," Nichols said.
