A guide to the validation of vision systems used in the pharmaceutical industry using Omron components
The main objective of this document is to provide a guide for final users and integrators, to help you understand the regulatory burden and achieve compliance with the applicable regulations.
Regulations vary across different industry sectors (e.g. pharmaceutical finished products / active ingredients, medical devices, biological products, blood products, vaccines, etc.), each having its own set of regulation, variable country by country.
In this document for simplicity we cover only manufacturing processes in the pharmaceutical industry (finished products) and the regulations applicable in the European Union and United States. Very similar considerations are nonetheless applicable for other regulated industries, processes and countries.
Among the many requirements, almost all regulations worldwide require the validation of processes and the qualification of supporting equipment. This document deals with validation of computerized systems used in pharmaceutical processes. It refers to the entire equipment for completeness, but is focused on the control system and is further specialized on vision systems as application examples.