Automation plays a key role in regulated industries like pharmaceuticals, finance, and healthcare, where it aligns closely with regulatory requirements. Ensuring Compliance : Automated tools promote uniform processes, precise data management, and co…

Why " Risk Assessment "is required in  Computer system validation (Learning with some observations). How can we control the issues of data integrity and How can controls require in electronic system.

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…

Webinar Session Discussed with Following Topic 1. What is FMEA and FMECA. 2. What is Risk. 3. How to Evaluate Risk . 4. How to metegate risk 5. Risk RPN no. 6. Many more >>                                                     Please Subscribe…

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 …

Data integrity refers to the accuracy, completeness and consistency of GxP data over its entire lifecycle. The steps that need to be overseen include the initial generation and recording, the processing (incl. analysis, transformatio…

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…

Introduction :-   A software requirements specification (SRS) is a detailed description of a software system to be developed with its functional and non-functional requirements. The SRS is developed based the agreement between customer and contracto…

User Requirement Specification: - User Requirement Specification is the Documentation Process of  System Requirement of  Different Parameter i.e Business, Process, Legal, Safety , regulatory performance and quality aspects of the future system as…