Bioprocessing White Papers

  1. The Lean Supply Chain – Electronic Kanban And Collaborative Supply Portals

    Lean manufacturing has become the de facto best practice across most manufacturing companies. Companies that have embraced lean principles have reduced their lead-times, improved quality, lowered inventory and engaged their employees. By Bill Swisher, Director of Business Development, Ultriva Inc.

  2. Controlled Environment Storage: The Case For Outsourcing Gets Stronger

    Anyone in business in the current economic climate knows that life is a constant struggle. Financial constraints, limitations on capital budget spend, and the ever-increasing need to reduce costs are all adding to the burden of trying to stay in business – and stay competitive. Inevitably, we all share some common challenges. By Patrick Jackson, Vindon Scientific

  3. Brand Protection Strategies: Defending Against Gray Market Diversion

    In this rapidly changing global economy, gray market diversion has become an ever increasing issue facing many brand owners today.

  4. The Invisible Component Of Cold Chain Management

    The practice of cold chain management continues to evolve rapidly.

  5. Reducing Laboratory Fume Hood Energy Consumption

    There is an ever-increasing demand for laboratories to have a reduced impact on the environment, as well as a lower cost to operate. With this continuing push for reduced energy consumption in laboratories, lab planners, architects, engineers, and lab managers are leaving no stone unturned. By Luke Savage, LEED Green Associate

  6. Six Ways To Optimize Your Quality Management System And Ensure FDA And ISO Compliance

    How much does quality cost? Most companies would be hard-pressed to translate “quality” into dollars and cents. What they realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.

  7. 5 Ways MasterControl Ensures System Compliance With 21 CFR Part 11

    Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems.

  8. Noncompliance To FDA Quality Standards: What's The Risk To Executives?

    Just imagine. Your company — hypothetically speaking — is now a successful and growthoriented organization. Thus far, you’ve kept governmental regulations in check, quality is steadily improving, and you’ve even managed to lower the cost of production. Then one day, the FDA shows up for an unannounced inspection of your facility. By Michael S. Heyl, J.D. Hogan & Hartson LLP

  9. How To Kick-Start Your CAPA Process

    The medical device industry faces the challenge of delivering safe and cost-effective products on time, every time. By Ken Peterson

  10. 21 CFR Part 11 Risk Of Non-Compliance

    When 21 CFR Part 11 took effect in August 1997, it was considered one of the most important regulations affecting pharmaceuticals, biotechnology, medical device, and other industries regulated by the FDA.