INSIGHTS ON REGULATORY COMPLIANCE

• How Digital Procedures And E-Logbooks Are Transforming Manufacturing

  Paper-based processes slow down life sciences manufacturing and introduce compliance risks. Discover how digital procedures and electronic logbooks can boost accuracy, speed, and traceability.

• Advanced Aseptic Filling Assembly Helium Integrity Testing

  Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.

• Revolutionizing Pharma Validation With AI

  Validation in GxP environments is often the bottleneck in digital transformation—manual, repetitive, and complex. One company's Intelligent Agents are transforming that process.

• The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

  In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

• Demolishing Doubts About AI In Pharma

  1/15/2025

  The FDA and PDA's recent initiatives provide frameworks and guidance for integrating AI into pharmaceutical manufacturing, emphasizing innovation, and safety.

• Leverage Apps To Reduce Line Changeover Time From 14 Days To 3

  6/26/2025

  A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

• At-A-Glance Monitoring: Inside The TSI FMS Web Client Dashboard

  8/4/2025

  Understand your environment quickly with real-time, customizable data and interactive controls, whether you manage a single site or multiple locations.

• Validation Of A Sterilization Process: Part 1

  9/9/2025

  Gain essential insights into sterilization by exploring microbial inactivation kinetics, bacterial spore resistance, and key terminology—critical knowledge for ensuring product safety and compliance.

• 4 Conversations To Drive Your Business Case For Digital Validation

  3/19/2025

  Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.