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.
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.
We provide guidance for preparing validation protocols & reports in the correct format so as to meet the regulatory requirements including DQ, IQ, OQ & PQ protocols & PQ report.
Medical Devices Validation services Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Validation of a machine or a process is carried out to ensure that products of consistent quality are manufactured and required level of compliance is met at every stage. Since a wide variety of procedures, processes & activities need to be validated; validation is divided into the following sub-sections: •HVAC validation •Equipment validation •Process validation •Facilities validation •Cleaning validation •Analytical method validation •Personnel validation •Packaging validation •Computer system validation Being a medical device consultant, Operon Strategist guides manufacturers & validation service providers for the validation activity & documentation. The product and the production facility are studied to document the validation master plan according to which validation activities will be performed as per the defined timeline.
Name: Clean Room Design