INSIGHTS ON QUALITY CONTROL

• Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance

  Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• QC Lab Program And Project Management

  A client aimed to consolidate quality control laboratory operations into a singular facility and operate as one organization. Gain insight into the services that helped deliver the project on schedule.

• Building A Connected Quality And Manufacturing Ecosystem In Life Sciences

  Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

• Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences

  1/13/2025

  Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

• Consolidating The Supply Chain For mRNA

  2/12/2024

  Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.

• Achieving Licensing For A Healthcare Solution

  6/16/2025

  Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.

• Water Activity: A Better Approach For Lyo Moisture Determination

  3/24/2025

  Explore why residual moisture content is crucial for freeze-dried pharmaceuticals and how water activity measurement can enhance product safety and stability with innovative laser-based methods.

• Improving Bioprocess Monitoring And Control With Multivariate Data Analysis

  12/9/2024

  Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.