INVENSYS has announced a comprehensive program to help pharmaceutical companies using Wonderware products comply with 21 CFR Part 11 U.S. Food and Drug Administration (FDA) regulations for electronic records and signatures.
This initiative unites the expertise of Validation Technologies -- a part of the Invensys Pharmaceutical Solutions group -- with Wonderware, a business unit of Invensys.
Together they plan to offer solutions enabling pharmaceutical customers to achieve regulatory compliance faster, and with greater cost effectiveness.
Validation Technologies is working as an auditor and consultant for Wonderware and is contributing its knowledge of specific FDA requirements that the pharmaceutical industry must follow.
The combination of Validation Technologies' FDA-compliance expertise and Wonderware's extensive background in the industrial control software field will facilitate the business unit's customer efforts to more easily comply with 21 CFR Part 11 and other regulatory requirements.
The Validation Technologies and Wonderware alliance is one example of Invensys' recent efforts to help companies using Wonderware products lower the costs of qualification, re-qualification and development of pharmaceutical applications.
Validation Technologies has actively consulted with Wonderware on 21 CFR Part 11 requirements to help the business unit establish software development standards that meet and exceed regulatory requirements.
The collaboration of these two industry leaders will result in continued Wonderware product enhancements, which will enhance customer FDA-compliance strategies.