Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have …

This video is about How Documents can be presented in a Regulatory Inspection for Better Representation and To Avoid Uncomfortable Scenarios during an Inspection     Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube…

Definitions:  System :-   A group / part of things that work together, in other words "A set of ideas or rules or component for organizing the things in a particular way that called system. Computerized System :-  Computer system is a set of in…

Previous Chapter: Discussed about the preparation of Installation qualification document and test.  Lets discuss about, How to prepare Operational Qualification Document and tests.  Many peoples are facing the issue for preparation of OQ and tes…

Many peoples are facing the issue for preparation of IQ and what are the tests to be performed in IQ. So Ugine are recommended the following test steps and script testing for Computer System Validation, Which is Helpful for preparing the Computer …

SOP For Preventive Maintenance Equipment   1.0 Purpose :-   The Purpose of the SOP is to Provide Procedure of Plant Preventive maintenance of Equipment. 2.0  Scope :- This Procedure is applicable for Preventive Maintenance of Equipment. 3.0 Respons…