Navigating FDA Compliance: A Guide to 21 CFR Part 210 and Part 211

In the pharmaceutical industry, ensuring the safety and quality of drugs is paramount. Manufacturers must adhere to stringent regulations set forth by the U.S. Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards.  For companies in the manufacturing, processing, packing, or holding of drugs, compliance with 21 CFR Part 210...

Unlocking Success: How the Right eQMS Can Be a Game Changer

In the highly regulated landscape of the life science industry, upholding uncompromising standards of quality is not just an option; it’s a necessity for achieving and sustaining success.  Whether you’re operating in the realms of pharmaceuticals, biotechnology, or medical devices, the quest to streamline operations, mitigate risks, and optimize efficiency is a constant pursuit.  Fortunately,...

The Evolution of Document Management Systems

Embracing the digital age, modern Document Management systems have evolved into powerful tools that streamline and enhance how organizations handle their crucial information.  In this era where efficiency, collaboration, and compliance are paramount, these systems have become indispensable for businesses across the life science industry. In this post we dive into the intricate components that...

How to Choose the Right QMS – The Ultimate Guide

In the highly regulated life sciences industry, quality management is crucial for ensuring product safety, regulatory compliance, and operational excellence. Choosing and implementing the right quality management software is a strategic decision that can significantly impact your organization’s success.  This guide provides a step-by-step process to help life sciences professionals navigate the selection of quality...

CAPA in the Age of Generative AI

Generative AI can revolutionize different processes in your business thanks to its many advantages. Once implemented, it can make your business more efficient, productive, and sustainable. Let’s go over some of its advantages:

How the use of AI is impacting life sciences manufacturing

The digital evolution of life sciences has opened the door to the implementation of advanced technologies. They are already revolutionizing how companies develop, manufacture and deliver products into the hands of clinicians and patients. Today, 45% of life sciences companies’ technology investments are made in three analytics-related technologies – applied AI, industrialized machine learning (ML),...

4 steps to speed value and minimize risk when deploying AI in quality management

While leveraging generative AI in BioPharma and MedTech manufacturing in a heavily regulated environment presents its challenges, there are ways manufacturers can minimize risk and maximize compliance.  Here are four critical steps to take when preparing for the use of generative AI within your eQMS to enhance enterprise-wide quality management.  1. Be strategic with structure...

5 ways AI will change the life science industry

Artificial Intelligence (AI) has revolutionized many industries, and the life science industry is no exception. AI will change the way we discover, develop, and deliver healthcare. Here are five ways AI will change the life science industry: 1. Drug Discovery Drug discovery is a complex and expensive process that involves identifying potential drug targets, designing...