INSIGHTS ON QUALITY ASSURANCE

• The Impact Of The FDA's New CSA Draft Guideline

  Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

• Accelerating Technology Transfer Through Unified Recipe Management

  See how a unified recipe authoring workflow can reduce technology transfer times in manufacturing, enhance validation efficiency, and streamline operations by integrating process control systems.

• Why Choose The Identifier Software?

  Unlock Pharma 4.0 for injectable drug inspection. Learn about a system that transforms data management, offering immediate access and global regulatory compliance.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• When And How To Implement Process Intensification

  10/3/2025

  Explore when to intensify your processes, what challenges to expect, and how to prepare for a successful transition with expert insights to help guide your strategy and ensure smoother implementation.

• Fast-Tracking Regulatory Submissions: How To Cut Review Time By 65%

  7/14/2025

  Discover how leading Biotech teams are eliminating SharePoint headaches, streamlining document reviews, and accelerating submission timelines without the chaos of version confusion or email overload.

• Closed Sampling: Crucial For Aseptic Processing

  6/26/2025

  Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.

• A Powerful Non-Destructive Tool For Tablet Characterization

  10/6/2025

  Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.

• Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation

  9/17/2025

  Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.