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Therac 25 :- The Therac-25 was a computer-controlled radiation therapy machine produced by Atomic Energy of Canada Limited (AECL) in 1982 after the Therac-6…

Software Development Life Cycle Use full for Pharmaceutical Industrious. Software Development Process work is 6 Phase 1. Planning Phase 2. Analysis Phase  3. D…

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Data management refers to all those activities performed during the handling of data including but not limited to data policy, documentation, qual…

Computer system Validation (Basics) are related to current regulatory requirement for use of Computer in GXP environment.                           …

Regulatory Agencies, like the FDA and EudraLex require companies to audit software vendors of their critical software and systems. Regulated companie…

This vedio is related to describe the Food and Drug Administration's (FDA’s) current thinking regarding the scope and application of part 11 of Ti…

Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can relia…

Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliab…

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 hardwa…

How to Qualify Analytical Instrument, Different Qualification approch.                                                                        Please Subsc…

Each country has its own regulatory authority, which is responsible to enforce the rules, regulations and issue the guidelines to regulate the drug developm…

Helpful for Pharmaceutical Software Compliance (CFR 21, Part -11) Topic- 1 Introduction Next Topic :- Different Regulatory Bodies and their name (Full Form…

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This Video is How To Prepare User Requirement Specification Document.                                                                        Please Subscribe …

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…

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 s…