INSIGHTS ON REGULATORY COMPLIANCE

• Are You Aligned With FDA's Computer Software Assurance Methodology?

  Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

• The Ex-Regulator's View On Small Surface Contamination Control

  Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. ​Learn about the critical steps, techniques, and validation needed to ensure product safety.

• Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2

  Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.

• Navigating The Evolution Of EU Health Technology Assessment (HTA) Regulation

  The future of pharmaceutical access in Europe is being shaped by the new EU HTA regulation. Insights from Pharma 2025, featuring Herbert Altmann and Alexander Natz, shed light on this pivotal shift.

• 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.

• How To Easily And Quickly Monitor Cleanrooms

  5/6/2024

  Discover a portable particle counter for quick and easy cleanroom monitoring that features automated alarms and reporting to help you ensure compliance.

• Characterizing The Effects Of Moisture On Pharmaceutical Materials

  12/30/2024

  Moisture impacts pharmaceutical ingredients’ stability and efficacy, causing phase changes and hydrate formation. Discovery SA enables humidity and temperature profiling for improved drug formulation.

• MilliporeSigma's 97-Day Implementation Success Story

  3/19/2025

  Discover how MilliporeSigma transformed validation processes with a digital validation system to achieve efficiency and compliance in just 97 days as well as learn key takeaways from their swift transition to digital validation.

• Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

  5/16/2025

  All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.