Regulatory Compliance White Papers & Case Studies

  1. FDA-Approved 3D Printed Drug Paves Path For Precision Care In Patients
    11/2/2018

    3D printing allows drug companies to not only boost efficacy and adherence but also contribute to their brand longevity by expanding and capturing market share with other dosage form options. 

  2. Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids
    10/17/2018

    Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.

  3. The Hidden Value Of Instrument Manufacturers
    7/2/2018

    Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible.

  4. The Case For A Facility Monitoring System
    3/27/2018

    While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.

  5. Inspecting On The Edge – Understanding Punch Tip Wear
    3/26/2018

    Avoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.

  6. Enhancing Process Safety In The Pharmaceutical Industry
    3/23/2018

    This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.

  7. How Fit Is Your Biopharmaceutical Manufacturing Facility?
    9/7/2017

    How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.

  8. Improving Documentation Change Control Process
    8/25/2017

    Changing and creating documentation involves many disciplines and long lead times. This case study explains how to improve Global Documentation Change Control Processes quickly and easily.

  9. Improving Compliance And Manufacturing Efficiency In Life Sciences
    8/7/2017

    Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. 

  10. Medical Device Manufacturer Improves Product Quality Control
    6/27/2017

    Osstem Implant adopted an integrated business framework that helps it eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.