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Practical guides on 21 CFR Part 11, electronic signatures, audits and digital SOPs for pharma and life sciences teams.
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Guides from the MSB Docs compliance team.
USP & FDA to Make Critical Updates to Good Storage & Distribution Practices
This blog post will discuss the proposed updates to Good Storage and Distribution Practices from the United States Pharmacopeia (USP) and the Food and
Equip Your Drug Launch with Nitrosamine Regulations: Essential Guide
This guide is designed to help organizations understand and comply with the nitrosamine regulations related to marketing applications for new drug pro
Need to Respond to FDA 483s? Here’s What You Need to Know
FDA 483 observations (or "Form 483s") are issued by the Food and Drug Administration (FDA) when findings of a GMP (Good Manufacturing Prac
Learn to Uncover Value from Clinical Trials in Australia
Australia is home to world-class medical research, and clinical trials are a major part of this. Clinical trials are federally regulated studies that
Transform Healthcare: Learn How AI & Automation are Changing Medicine
With the introduction of Artificial Intelligence (AI) and automation, the medical information industry is undergoing a radical transformation.
Unlock the Potential of Clinical Research: Why Decentralized Clinical Trials Are the Future
Decentralized clinical trials (DCTs) are a new approach to conducting clinical research that shifts the traditional model in significant ways.
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