Featured Pharma Online Editorial

1. Fostering A Quality Software Culture 11/24/2025

   Transforming the quality culture should include the adoption of software quality engineering (SQE), but what is it, and how can it impact the quality of your products and processes?

2. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

   The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

3. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

4. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

   Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

5. Shaping The Future Of GLP-1 Quality 11/4/2025

   Three experts—Doug Bakan (CTO of Kailera), Hyung Heon Kim (CEO of MetaVia) and Deepa Nagpal (Founder of SygnifyQ)—joined us on Oct. 15, 2025, to explore this topic, find out the most common quality failures, learn what innovation is occurring and find out what business decisions can help support both quality and quantity.

6. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

7. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

   Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

8. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

9. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

   The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

10. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.