Abstract

“Validating a process means establishing Documentary Evidence to ensure that a product conforms to a specific process, predetermined specifications, and quality characteristics.”

Why and When to perform Validation?

To comply with obligations related to:

• Product quality
• Performance of the production process
• Legislative obligations.

This presentation outlines the Fundamental and Procedural Aspects of the analysis required to carry out validation, the relative Technical Writing and Management of the specific Documentation and provides the elements necessary to define the fields in which validation is most applicable.

This presentation also illustrates the approach and methodology for Risk Analysis as a fundamental step to perform Validation in an appropriate and objective manner by highlighting some of the most common errors in the technical writing of documentation and test specifications.

During this presentation the analysis of the relationship between Technical Communicator and Validation: where does the Technical Communicator fit into this process? What type of documentation is produced and how is it managed?

Speaker

Fabio Farneti