FEATURED ARTICLES

• 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.

• 4 Conversations To Drive Your Business Case For Digital Validation

  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.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Discover how organizations like Catalent must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• MilliporeSigma's 97-Day Implementation Success Story

  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.

• Digitalizing Pharma Control Strategies: A Roadmap

  Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

• Move Beyond Manual CQV Challenges With Digital Solutions

  Review how digitalizing commissioning, qualification, and validation (CQV) with a new software streamlines processes, enhances compliance, and reduces time to drive efficiency and sustainability.

• Building Control Strategies: It's Time To Go Digital

  Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.

• Validating Pharma 4.0 For Smart Manufacturing

  Explore the digital evolution of manufacturing control and management, the building blocks of Pharma 4.0, and how the life sciences industry can realize the full potential of Pharma 4.0.

• Avoiding The Pitfalls Of PQR

  Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

• What Changes When Your CPV Goes Digital

  Explore the advantages of digitalizing Continued Process Verification (CPV) through the experience of a pharmaceutical company step-by-step.

• Bypassing The Challenges Of Paper-Based Validation

  Gain insight into why a biotechnology startup and CDMO views investment in a digitized validation lifecycle management system as crucial for accelerating innovation and reducing time to market.

• Seizing The Opportunity To Go Paperless

  Learn how specialty pharmaceutical company Noven Pharmaceuticals successfully launched a new computer system validation by upgrading their enterprise resource planning system.

• Combining Digital Platforms And QbD Principles

  How can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?

• The Shift From CSV To CSA

  Explore current industry challenges, the urgent need to implement Computer System Assurance (CSA), and an approach to aid the pharmaceutical sector in understanding and embracing this essential shift.

• The Path To Digital CPV

  Learn to embrace a digital CPV approach to proactively detect and address process deviations, ensuring continuous improvement and enhanced quality throughout the product lifecycle.

• Revolutionizing Manufacturing For Pharma And Biopharma

  Explore the evolution of Industry 4.0 in pharmaceutical manufacturing, the benefits and implications of Smart Factories, and the challenges along the road toward implementing a Smart Factory.

• Risk Management Processes For Cell And Gene Therapies

  Delve into several considerations of risk and knowledge management in the cell and gene therapy environment, providing essential insights for effective product development.

• Real-Time Monitoring: Why Have It And How To Get It

  Uncover how automation and real-time monitoring across all process steps provide the rapid response and control needed for successful continuous manufacturing.

• ICH Q12 Implementation: Regulatory Intelligence And PACM Agility

  Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

• Best Practices In Commissioning And Qualification

  An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.