System validation with Experion PKS

For manufacturers subject to regulations enforced by the U.S. Food and Drug Administration (FDA) and other agencies worldwide, it is critical that processes and systems are validated. This white paper by Honeywell Process Solutions provides a description of the validation process and discusses how Honeywell systems and services can assist clients with project validation. Additionally, it discusses the requirements of 21 CFR Part 11-Electronic Records, Electronic Signatures  including Honeywell system features and services that assist clients in meeting this requirement. 

The intent of this white paper is to provide a broad view of the required elements for supporting the system validation to the pharmaceutical regulated industry. As no two projects are identical, detailed responses are supported on a project basis as part of the functional specification.

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