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Jan 3, 2024

21 CFR Part 11

The timeline of the 21 CFR Part 11 (Code of…

Dec 10, 2023

Embracing the Era of Digital Transformation

In today’s rapidly evolving technological landscape, digital transformation has become…

Nov 20, 2023

ICH Q8 – Quality by Design

The ICH Q8 guideline focuses on pharmaceutical development. It aims to establish a systematic approach…

Nov 10, 2023

From Simple to Spectacular: A Beginner’s Guide to Technical Drawings

Drawings are a graphical way of representing an idea, a concept, or…

Oct 26, 2023

The Complete CQV: Where to Start

Commissioning, Qualification, and Validation (CQV) in the life science pharmaceutical…

Oct 24, 2023

As-Built Data: A Vital Component of Construction Project Handover

Maintaining as-built information is critical throughout the lifecycle of a facility project. As-built…

Oct 9, 2023

Factory Acceptance Test: The Beginning of Quality Built Equipment

When a customer is purchasing new factory equipment, it is important to verify…

Oct 5, 2023

ICH Guidelines Decoded

The International Council for Harmonisation (ICH) is an organization that brings together…

Sep 25, 2023

Navigating the Regulatory Maze: How PSC Biotech Lights the Way

Regulatory affairs (RA) is a profession in the life science…

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