Regulatory Articles

  1. Six Ways To Optimize Your Quality Management System And Ensure FDA And ISO Compliance
    9/5/2013

    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.

  2. 5 Ways MasterControl Ensures System Compliance With 21 CFR Part 11
    9/5/2013

    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.

  3. Noncompliance To FDA Quality Standards: What's The Risk To Executives?
    9/5/2013

    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

  4. How To Kick-Start Your CAPA Process
    9/5/2013

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

  5. 21 CFR Part 11 Risk Of Non-Compliance
    9/5/2013

    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.

  6. Managing Change Control To Comply With FDA And EU Regulations
    9/5/2013

    When properly implemented, change control is a potent force for improving the efficiency and effectiveness of a quality system. Many organisations find change control management to be a major problem because of the extensive documentation it generates, and the difficulty of managing the large number of interrelated elements and departments that are often involved.

  7. 21 CFR Part 11 Industry Overview: Ready For An FDA Inspection?
    9/5/2013

    The U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 in 1997 to establish criteria for the use of electronic records and electronic signatures by organizations that comply with the federal Food, Drug, and Cosmetic Act and the Public Health Service Act. 

  8. How To Successfully Manage Your Suppliers And Ensure Product Safety And Compliance
    9/5/2013

    The more advanced manufacturing has become, the more streamlined it has gotten. Parts come from various suppliers throughout the world; certain functions or entire processes are outsourced.

  9. Foolproof Investigations: A Proven Approach For Root Cause Analysis In A Regulated Environment
    9/5/2013

    The life science industries face the challenge of delivering safe and cost-effective products on time, every time. The pressure to put products into the marketplace is undoubtedly intensified by the strict guidelines enforced by the FDA and other regulatory bodies worldwide.

  10. Effective Nonconformance Management Key To FDA And ISO Compliance
    9/5/2013

    A product’s quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved.