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…

Vendor assessment as per GAMP 5 involves a comprehensive evaluation of vendors who supply software, hardware, and services that can impact the quality and compliance of a regulated system. The purpose is to ensure that vendors can consistently provi…

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 …

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…

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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. Aseptic process simulation 7. Laminar Air Flow 8. Aseptic filling failure                   Pl…

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 …

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

Analytical Balance are highly sensitive lab instruments designed to accurately measure mass. Their readability has a range between 0.1mg - 0.01mg. There should be compliance in minimum requirements of current regulatory. A short overvi…

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…

ICH Quality Guideline                                         Please Subscribe my You tube Channel   Watch Full Section Click Link and You Tube Button Video        Watch More Videos Click Here

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…

we are here to discuss about the current regulatory requirement in pharmaceutical industry                                                                        Please Subscribe my You tube Channel   Watch Full Section Click Link and You …

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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 reliably output products of a determined standard. Regulatory authorities like EMA and FDA have…