Regulatory Articles

  1. Case Study: ImmucorGamma Goes Paperless With TrackWise 6/7/2006
    Implementation of TrackWise for Calibrations and Preventive Maintenance (Cal-PM) at ImmucorGamma
  2. Case Study: Acist Medical Streamlines CAPAs, MRBs, Incoming Inspections And Contract Management With TrackWise 6/7/2006
    ACIST Medical Systems manufactures state-of-the-art contrast injection systems used by operating rooms, radiology and cardiac labs for both diagnostic and interventional procedures
  3. How To Recognize Effective CAPAs And A Culture Of Quality

    When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.

  4. Successful Industrialization Requires Solid Foundations

    Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.

  5. The Benefits of Aqueous Critical Cleaning In Manufacturing

    The use of aqueous cleaning in medical device manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact and reduced residue potential, and easier cleaning validation.

  6. Demystifying Performance Testing: Strategies To Qualify Combination Products

    Explore applicable regulations and guidances, and performance risks identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses.

  7. Addressing Glass Particulates In Injectable Drug Formulations

    Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

  8. Create An Effective Risk Management Program

    Drug-device combination products are rapidly increasing in use, based on their numerous benefits. This article is a review of achieving performance and regulatory compliance for their successful development and commercialization.

  9. A 15-Minute Guide To Compliant Document Management For Life Sciences

    Life Sciences quality and manufacturing organizations face three critical industry forces:  increasingly stringent regulation; globalization; and virtualization of supply networks.

  10. A 15 Minute Guide To Efficient And Compliant Management Of GMP Controlled Documents

    Life Sciences quality and manufacturing organizations face three critical industry forces: increasingly stringent regulation; globalization; and virtualization of supply networks.