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CSV in Pharma

Comparative Overview of Drug Regulatory Systems: FDA, EMA, and CDSCO

Introduction Regulatory systems play a vital role in ensuring that medications are safe, effective, and of high quality before reaching the public. These frameworks protect public health by enforcing stringent requirements for the approval, monitoring, and distribution of pharmaceutical products. Through comprehensive evaluations of clinical trial data, manufacturing standards, and post-marketing surveillance, regulatory authorities work […]

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Understanding and Avoiding Common Mistakes in Computerized System Validation (CSV) Files

Introduction In regulated industries such as pharmaceuticals, biotechnology, and healthcare, Computerized System Validation (CSV) is a critical process that ensures computer systems used to store, process, or generate regulated data are functioning correctly, consistently, and in compliance with relevant standards. CSV files play a central role in this validation process, documenting essential system activities and

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Exploring the Impact of CSV Vacancies: Trends, Challenges, and Opportunities in the Pharma and Healthcare Industry

Introduction Overview of the significance of Computer System Validation (CSV) in the pharma and healthcare industry :- Computer System Validation (CSV) is a critical process in the pharmaceutical and healthcare industries, ensuring that computer systems used in the development, manufacturing, and distribution of medical products are reliable, accurate, and compliant with regulatory standards. CSV involves

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What Is Computer System Validation (CSV) and Why It’s Crucial for Compliance

Introduction Definition of Computer System Validation (CSV). Computer System Validation (CSV) is the process of ensuring that computer systems and software used in regulated environments consistently produce accurate, reliable, and compliant results. This involves a series of documented activities that confirm the system meets its intended purpose and complies with relevant regulations and standards. CSV

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USFDA 483 on Access Management of Computerized System

USFDA 483 on Access Management of Computerized System

Observation   1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm manufactures over-the-counter (OTC) drug products, including alcohol-based hand sanitizers[1]. During the inspection of your facility, our investigator attempted

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Top online institutes to get your "Computer system Validation training & certification"

Top online institutes to get your “Computer system Validation training & certification”

Our annual ranking on Computer System Validation (CSV) training institute aims to highlight the best providers of CSV training in India and Outside of India. The ranking is concluded after an in-depth analysis and a detailed process of vetting through various training institutes in India, US, Ireland, China and Rest of the word. We reached

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Category Of Software & Hardware As Per GAMP Guideline & their Validation

Category Of Software & Hardware As Per GAMP Guideline & their Validation

Category of software Application are categorized into following software categories as per GAMP 5 guideline 1. Category 1 – Infrastructure Software:- There are two types of software in this category: A. Commercially available layered software: – Software upon which applications are built or applications are developed to run under the control of this kind of

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