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Importance of Computerized System Validation in the Current Regulated Environment

Introduction In today’s heavily regulated pharmaceutical, biotech, medical device, and healthcare sectors, computerized systems have become pivotal in ensuring the control of such critical operations as production, quality control, regulatory submissions, pharmacovigilance, and clinical research. As companies have transitioned from paper-driven systems to totally electronic systems, reliance on these computerized systems has escalated exponentially. Although […]

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A Newcomer’s Guide to Understanding LIMS Software

Introduction A Laboratory Information Management System, or LIMS, is a computer-based application developed to support laboratory operations through the management of samples, associated data, workflows, and laboratory information. It is a centralized system for storing, tracking, and analyzing laboratory data that permits workflow automation, regulatory compliance, and resource management with ease. LIMS is essential for

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Virtualization and Containerization: A Detailed Overview

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Virtualization and Containerization: A Detailed Overview Virtualization Virtualization is a foundational technology in modern computing that allows the creation of virtual replicas of physical computing resources. These resources can include servers, storage devices, networks, and applications. The central idea behind virtualization is to enable multiple virtual machines (VMs) to operate independently on a single physical

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Soft Skills That Make a Successful Regulatory Affairs Specialist

Introduction A Regulatory Affairs Specialist’s main job is to ensure that businesses adhere to all laws and regulations for their line of business. Mainly working in the pharmaceuticals, medical devices, biotech, and food production industries, these individuals must prepare, submit, and maintain regulatory files needed for product approval and stay compliant over the life of

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Why CSV Matters in Regulated Industries

Introduction Computer System Validation consists of the activity necessary to confirm that computer systems perform their intended functions reliably, accurately, and consistently in a regulated environment. The testing and documentation of software and hardware systems are included in this, ensuring they meet predefined specifications and regulatory requirements. CSV is not only meant to confirm system

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Regulatory Affairs in India: Trends and Opportunities

Introduction Regulatory affairs in India are core in the pharmaceutical and healthcare industries, positioning products to meet the high standards both nationally and globally. The apex regulatory organization is the Central Drugs Standard Control Organization, which monitors the approval, quality assurance, and regulatory compliance of drugs and medical devices. Regulatory affairs have gained prominence with

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Change Control in CSV: Handling System Updates Without Risk

Introduction Change control is one of the most important elements of CSV, which provides assurance that changes to validated systems are examined systematically, documented, and implemented without compromising the system’s integrity, compliance status, or intended function. In regulated industries like pharmaceuticals, biotechnology, and medical devices, where computerized systems manage data impacting product quality and patient

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Understanding SAP S/4HANA: A Complete Beginner’s Guide for the Pharmaceutical Industry

Introduction The pharmaceutical industry faces serious pressure regarding enhancing operational effectiveness while strictly observing regulatory standards in continuous development. For many organizations, balancing these imperatives within an environment that is highly competitive and driven by innovation is a challenge. Consequently, more pharmaceutical companies have begun taking advantage of advanced digital solutions to streamline operations, maintain

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Validating Excelsheets: Effective Approaches to Improve Data Accuracy

Data integrity is everything in today’s modern world. Whether it deals with financial reports, sales forecasts, or inventory tracking, several business outcomes are hinged on data accuracy. Excel sheets, being versatile, are used across industries to handle data. However, human error and incorrect formulas and inconsistency in data entry can jeopardize the accuracy of the

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Continuous Validation: Is It the Future of CSV?

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Introduction Explanation of Continuous Validation (CV) and its relevance in the context of Computer System Validation (CSV). Continuous Validation (CV) is an advanced approach to ensuring that computerized systems remain in a validated state throughout their lifecycle. Unlike traditional Computerized System Validation (CSV), which follows a one-time validation process at a specific point in time,

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