Automation plays a key role in regulated industries like pharmaceuticals, finance, and healthcare, where it aligns closely with regulatory requirements. Ensuri…

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

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…

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.…

This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of …

Data integrity refers to the accuracy, completeness and consistency of GxP data over its entire lifecycle. The steps that need to be overseen i…

Previous Chapter: Discussed about the preparation of Installation qualification document and test.  Lets discuss about, How to prepare Operational Qualific…

Introduction :-   A software requirements specification (SRS) is a detailed description of a software system to be developed with its functional and non-functi…

User Requirement Specification: - User Requirement Specification is the Documentation Process of  System Requirement of  Different Parameter i.e Business, P…