The Documents required during the activities of CSV are very important for the quality, safety, and efficacy of  the final product. As per regulatory requirements, what is the minimum documentation required during the activities summarized here in …

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Live Webinar Session On Dated 31.12.2021 for Computer Sytem Validation Topic for your Knowledge 1. Basic Regulerty Guideline 2. Basic CSV Approch 3. More Query                                                                        Please Sub…

This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities    Please …

Lets discuss about analytical instrument qualification.    Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube Button Video        Watch More Videos Click Here

How to Qualify Analytical Instrument, Different Qualification approch.                                                                        Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube Button Video        …

Each country has its own regulatory authority, which is responsible to enforce the rules, regulations and issue the guidelines to regulate the drug development. These different regulatory authorities are having different set of guidelines to ensu…

Video on How to write Simple SOP, Reduce Number of Entries, Reduce Checkpoints and Increase Productivity and Reduce Menpower                                                                          Please Subscribe my You tube Channel   Watch Fu…

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 …