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  • Digitalisasi

    Penjelasan Detail dan Implementasi GAMP 5 dalam Area GxP

    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...

    by • 28 Apr 2025
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    Kecerdasan Buatan (Artificial Intelligence): Penjelasan Mendalam Mengenai Konsep, Teknik, Implementasi, Tantangan, dan Masa Depan (Perspektif 2025)

    1. Pendahuluan: Mendefinisikan Lanskap Kecerdasan Buatan Kecerdasan Buatan (Artificial Intelligence – AI) telah menjadi kekuatan transformasional di abad ke-21, meresapi hampir setiap aspek kehi...

    by • 28 Apr 2025
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    Good Laboratory Practices (GLP) within the GxP Framework for Vaccine Manufacturing Implementation

    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...

    by • 20 Apr 2025
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    Penilaian Risiko Fungsional (Functional Risk Assessment – FRA) Menurut GAMP® 5 di Area GMP: Panduan Komprehensif

    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...

    by • 20 Apr 2025

    Penerapan Integritas Data ( Data Integrity )pada GxP Farmasi dan Life Science.

    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...

    by • 31 Mar 2025

    Designing a Library Application Using Google AppSheet

    Introduction: The Power of No-Code in Modern Library Management In an increasingly digital world, libraries are continually seeking innovative ways to enhance their services and streamline their opera...

    by • 31 Mar 2025

    Laboratory Information Management Systems (LIMS) in GxP Manufacturing

    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...

    by • 25 Mar 2025

    Proses Digitalisasi pada Area Produksi Berbasis GMP

    1. Pendahuluan: Imperatif Digitalisasi dalam Produksi Teregulasi GMP Dalam beberapa dekade terakhir, manufaktur farmasi telah memperluas jangkauan globalnya secara signifikan. Permintaan akan produk f...

    by • 25 Mar 2025

    ISO 27001 Information Security Management System: A Strategic Imperative for Organizations in Bandung, West Java

    1. Executive Summary In an era defined by increasing digital connectivity and sophisticated cyber threats, the security of information has become paramount for organizations across the globe. This rep...

    by • 23 Mar 2025

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