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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 and Therac-20 units (the earlier units had been produced in partnership with CGR of franc…

Software Development Life Cycle Use full for Pharmaceutical Industrious. Software Development Process work is 6 Phase 1. Planning Phase 2. Analysis Phase  3. Designing Phase 4. Coding Phase 5. Testing Phase 6. Deployments Phase or Maintenance Phase …

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…

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

Data management refers to all those activities performed during the handling of data including but not limited to data policy, documentation, quality and security. Good data management practices influence the quality of all data generat…

Computer system Validation (Basics) are related to current regulatory requirement for use of Computer in GXP environment.                                         Please Subscribe my You tube Channel   Watch Full Section Click Link and You…

Regulatory Agencies, like the FDA and EudraLex require companies to audit software vendors of their critical software and systems. Regulated companies include several industries – Pharmaceuticals, Biologics, Medical Devices, Clinical Studi…

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 Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 C…

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…

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 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                              …

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…

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

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…

This Video is How To Prepare User Requirement Specification Document.                                                                        Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube Button Video        Watch…

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…

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 …