Bioprocessing White Papers

  1. Foolproof Investigations: A Proven Approach For Root Cause Analysis In A Regulated Environment

    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.

  2. Effective Nonconformance Management Key To FDA And ISO Compliance

    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.

  3. Selecting An Electronic Lab Notebook: 7 Things You Must Know

    Electronic lab notebooks (ELNs) are one of the primary scientific informatics solutions for helping scientists design, execute, analyze and report on experiments—but selecting the right ELN can be a challenge.

  4. The Top 5 Benefits Of Electronic GLP Audit Management

    Since science and management industries are industries running at breakneck speeds, it’s no surprise that life science companies such as non-clinical research laboratories are maintaining business at uncomfortable warp speeds.

  5. Automating Training Control Processes

    FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training.

  6. How Effective Document Management Helps Pharmaceutical Companies Accelerate Time To Market

    This white paper will discuss common challenges pertaining to document control encountered by most drug companies from the preclinical stage through the post-market phase, and how the MasterControl™ GxP process and document management software solution addresses such challenges to accelerate time to market and improve product quality.

  7. Automating Document Control Processes

    The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMP) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. 

  8. Simplifying CAPA: Seven Steps

    Troubleshooting problems and attempting to identify and prevent potential problems is a typical activity for most businesses.

  9. Quality Audit - A Tool For Continuous Improvement And Compliance

    The word “audit,” in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

  10. Does Your CAPA Need A CAPA?

    Conceptually, performing corrective and preventive actions (CAPA) sounds like a very good idea.