All about GxP regulation form Computerized Systems
Executive Summary Design Qualification (DQ) stands as the pivotal, foundational step in the Computer System Validation (CSV) lifecycle for systems operating within GxP-regulated environments. This rep...
I. Pendahuluan: GAMP 5 dan Kepatuhan GxP A. Keharusan Validasi dalam Industri Teregulasi Dalam industri ilmu hayati (life sciences), termasuk farmasi, bioteknologi, dan perangkat medis, validasi siste...
I. Introduction: Situating GLP within the GxP Framework for Vaccine Development A. Overview of GxP in the Pharmaceutical Lifecycle The development, manufacturing, and distribution of pharmaceutical pr...
1. Pendahuluan: GAMP® 5, GMP, dan Pentingnya Manajemen Risiko Lingkungan Good Manufacturing Practice (GMP) modern, termasuk manufaktur farmasi, laboratorium, dan uji klinis, sangat bergantung pada si...
1. Pendahuluan: Peran Penting Integritas Data dalam GxP untuk Farmasi dan Ilmu Hayati Kepatuhan terhadap Good Practices (GxP) mencakup serangkaian pedoman dan peraturan yang dirancang untuk memastikan...
The pharmaceutical and biotechnology industries operate under a rigorous regulatory landscape, where the integrity and reliability of laboratory data are paramount to ensuring the quality, safety, and...
1. Pendahuluan: Imperatif Digitalisasi dalam Produksi Teregulasi GMP Dalam beberapa dekade terakhir, manufaktur farmasi telah memperluas jangkauan globalnya secara signifikan. Permintaan akan produk f...
Executive Summary Good Practice (GxP) regulations are fundamental to the pharmaceutical industry, ensuring that medicinal products are safe, effective, and of high quality. These guidelines govern all...
1. Introduction: The Convergence of Operation Technology and GxP in Manufacturing Operation Technology (OT) is the practice of employing hardware and software to control industrial equipment, primaril...
Introduction: The Critical Role of Electronic Batch Records in GxP Compliance for Pharmaceutical Manufacturing In the highly regulated pharmaceutical industry, ensuring the safety, efficacy, and quali...
As the timeline of technology perpetually accelerates, 2023 emerges as a testament to human creativity and ingenuity. The realm of gadgets is no...
As the timeline of technology perpetually accelerates, 2023 emerges as a testament to human creativity and ingenuity. The realm of gadgets is no...
Good “x” Practice (GxP) is a broad term encompassing a collection of regulations and guidelines that govern various disciplines with...
Tutorial pembuatan Faktur pada Aplikasi Laboratorium Klinik sederhana
Introduction: The Power of No-Code in Modern Library Management In an increasingly digital world, libraries are continually seeking innovative w...