Compliance Management White Papers & Case Studies

1. Optimal Microbial Sampling Criteria 6/24/2025

   Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

2. Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing 6/13/2025

   Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.

3. 5 Steps To Completing A Successful Root Cause Analysis 5/30/2025

   Discover how Root Cause Analysis transforms manufacturing by addressing underlying issues, improving quality, and preventing future failures, which empowers teams to move from reactive fixes to strategic solutions.

4. How Manufacturers Navigate Labor Shortages, AI, And Quality Challenges 5/30/2025

   Review a survey that reveals key industry challenges such as labor shortages, skills gaps, and safety risks, while also spotlighting AI adoption and rising investment in quality innovation.

5. Guide To Navigating The Complex And Expanding Regulatory Landscape 5/30/2025

   In today’s complex landscape, organizations face growing compliance demands from diverse sources. Learn how a strong compliance system and culture of accountability drive sustainable growth and protect long-term success.

6. Top 10 Pharma Company Uses Validation Technology To Streamline CQV 5/14/2025

   Discover how a Top 10 global pharma company saved over $900K using validation technology, as well as explore their digital CQV transformation to learn how you can achieve similar results.

7. 2025 State Of Validation: Key Insights 5/14/2025

   Discover what’s driving change in validation in your industry in 2025 by exploring key Insights for a first look at this year’s top trends, challenges, and opportunities in validation.

8. The Impact Of Annex 1 (2022) On Sterility Assurance 4/24/2025

   Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.

9. Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements 6/19/2024

   Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

10. Selecting, Implementing, And Using FDA Compliance Software Solutions 2/28/2013

    We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”