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

Vendor assessment as per GAMP 5 involves a comprehensive evaluation of vendors who supply software, hardware, and services that can impact the quality and comp…

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

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.…

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Your Queries: 1. Media Fill Failure Investigation 2. Media failure 3. Aseptic filling 4. Investigation 5. How to investigate media Fill Failure 6. Asep…

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

Lets discuss about analytical instrument qualification.    Please Subscribe my You tube Channel   Watch Full Section Click Link …

Analytical Balance are highly sensitive lab instruments designed to accurately measure mass. Their readability has a range between 0.1mg - 0.01mg…

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

ICH Quality Guideline                                         Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube But…

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…

we are here to discuss about the current regulatory requirement in pharmaceutical industry                                                           …

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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…