Validation, Commissioning & Design White Papers & Case Studies

  1. Streamlining Change Control To Increase Efficiency And Compliance 2/27/2024

    Here, we outline a holistic approach to streamline the change control process, aiming to increase efficiency and compliance, improve quality, and shorten time-to-market.

  2. Streamlining Change Control For CDMOs 2/26/2024

    Here, we outline a holistic approach for CDMOs to streamline the change control process, aiming to enhance quality, compliance, and time-to-market.

  3. Building A Compelling Business Case For Quality Transformation 2/26/2024

    Discover the key to a successful quality transformation, explore the business value of modern quality systems, and learn how quality leaders can build a compelling case for change.

  4. Optimizing Process Loads For VHP Decontamination 2/20/2024

    Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.

  5. The Most Significant Quality Measurement For Manufacturers 1/22/2024

    Learn how a life sciences manufacturer generated a contextualized data set that eliminated the manual effort required to curate production data and improved their process in real time.

  6. Advancing Compliance And Digital Strategy To Align With Pharma 4.0 11/21/2023

    AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.

  7. Reliability Assessments And Benchmarking In Life Sciences 11/7/2023

    Gain insight into how a prominent medical device manufacturer observed a significant improvement in its plant-wide OSHA recordable rate and cost of goods savings of over $100,000/year in just one year.

  8. The Role Of The Technical Transfer Executive Sponsor 10/30/2023

    Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

  9. Regulatory And Quality Consulting, Operational Readiness Services 10/5/2023

    Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.

  10. Meeting An Aggressive Go-To-Clinic Timeline 9/27/2023

    Finding an outsourcing partner capable of giving your company proper attention and meeting project milestones on schedule is crucial to ensuring patients in need receive treatment in a timely manner.