Articles

Medical Device Process validation

by anil chaudhari Medical Device project Consultant

Operon Strategist guides manufacturers & validation service providers on the validation activity & documentation.We study the product & the production facility & accordingly design the validation master plan which outlines the validation activities to be performed & timeline for the same.

Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages. In particular, we provide the following validation services.

Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Since a wide variety of procedures, processes & activities need to be validated.


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About anil chaudhari Junior   Medical Device project Consultant

2 connections, 0 recommendations, 15 honor points.
Joined APSense since, January 16th, 2017, From pune, India.

Created on Mar 1st 2018 06:31. Viewed 385 times.

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