Where Engineers and Quality Managers Come to Learn About Process Validation

Free Resources for conducting process validation

The following links take you to a series of free documents that help you further understand the requirements and expectations for process validation.

Start with "Process Validation Guidance" by GHTF.  The latest edition was published in 2004.  It explains the concepts of IQ, OQ, and PQ very well.  For standard terminology you should utilize in your own procedures and protocols, reference the "Definitions" section in this document. There is also useful information about process design and other six sigma tools in the Annex. 

Although not written for medical devices, the latest FDA Guidance Document is an excellent place to study the FDA's current thinking on process validation.  The importance of scientific data analysis and a holistic approach to process validation is presented. In my opinion medical device manufacturers should take the same approach.

Learn more about Software Validation here. This OSHA site provides non mandatory guide lines for machinery and machine guarding.

This FDA preamble provides some insight why process validation is required.  Use Ctrl F and type validation into the search window.  Read all the comments and thoughts regarding validation and verification.

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