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...
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...
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...
Introduction: The Critical Role of Electronic Batch Records in GxP Compliance for Pharmaceutical Manufacturing In the highly regulated pharmaceu...
1. Pendahuluan: Imperatif Digitalisasi dalam Produksi Teregulasi GMP Dalam beberapa dekade terakhir, manufaktur farmasi telah memperluas jangkau...
Tutorial pembuatan aplikasi laboratorium klinik dengan menggunakan Microsoft Access
1. Introduction: The Importance of Business Continuity in Today’s Landscape The modern operational environment is increasingly characteriz...
As the timeline of technology perpetually accelerates, 2023 emerges as a testament to human creativity and ingenuity. The realm of gadgets is no...