Healthcare

WHITE PAPERS AND CASE STUDIES

• Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination

  Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• Digitalizing Batch Records In Pharmaceutical Production

  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

• Understanding Biosafety Levels

  Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• MilliporeSigma's 97-Day Implementation Success Story

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

• Advances In Regulations For Viable Environmental Monitoring

  Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• Preparing The Next Generation Of Clinical Research Professionals

  Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.

• Improving Protocol Design With An Early Think-Tank Initiative

  Explore how a client's first-in-human trial for a cancer drug was improved by using a think-tank approach and gap analysis, accelerating protocol design and streamlining development.