Latest Insights

FemTech

The Critical Role of Data in Advancing FemTech

Discover how clinical data, AI, and technology are transforming FemTech to close the gender health gap and enable personalized care for women

CSV & Data Integrity

Why Computer Software Assurance (CSA) Is the Future of Validation in Life Sciences

CSA: the future of validation in life sciences—smart, risk-based, and patient-focused

GxP Compliance

FDA Expands Surprise Inspections: What Foreign Manufacturers Need to Know

The FDA expands unannounced inspections to foreign manufacturers: find out what this means for your company and how to prepare yourself

Clinical Research

How ICH E6 Revision 3 Is Redefining Our Understanding of Clinical Trials

Discover how ICH E6(R3) is redefining clinical trials with a modern, flexible, and patient-centric approach

GxP Compliance

The Pharmaceutical Industry’s Path to Sustainable Development

This article covers the pharmaceutical industry's push for sustainability through ethical sourcing, innovation, and supply chain challenges.

Artificial Intelligence

The Role of the Quality Professional in the Evolution of AI in BioPharma and Medical Devices

AI is transforming biopharma—learn its impact on Quality professionals and why preparation starts now.

Annex 1

New GMP Annex 1: How to Stay Ahead in Sterile Manufacturing

Stay ahead with the new EU GMP Annex 1—discover key updates on QRM, CCS, and cleanroom monitoring for compliance and product safety.

GxP Compliance

Embracing Paperless Validation in a Fast-Evolving Life Sciences Industry

Embrace paperless validation to streamline workflows, enhance compliance, and reduce costs while meeting evolving regulatory standards in life.

Commissioning, Qualification and Validation (CQV)

Why Equipment Qualification & Validation are Non-Negotiable in Life Sciences

Equipment Qualification & Validation: essential for quality, safety, and compliance in Life Sciences manufacturing

Artificial Intelligence

Why Life Sciences Needs Responsible AI use with Human Validation

Learn how AI validation, ethics, and oversight ensure safe, effective AI in life sciences under the EU AI Act.