Compliance

WHITE PAPERS AND CASE STUDIES

• Software Automation In The Blood And Biologics Industry

  Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

• Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

  Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

• California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
• Sporting Goods Retailer Takes Safety And Product Testing To A New Level

  This U.S.-based retailer is an omni-channel sporting goods powerhouse offering a broad assortment of top-brand sporting goods equipment, apparel and footwear. They operate 645 locations with a blend of dedicated associates, in-store services and unique specialty shop-in-shops. As a producer of reliable, high-quality products that their loyal customers have come to expect, product safety and compliance are major focuses for this sporting goods retailer.

• WIMAX With Differentiation By Elvis Tucker, Aperto Networks The WiMAX Forum defines the profiles that any WiMAX-compliant broadband wireless access systems must support in order to achieve inter-operability. But while inter-operability is an important goal for any WIMAX-compliant system, it will not ensure optimization. Submitted by Aperto Networks
  
  
• Electronic Informed Consent: Considerations For Implementation In Clinical Trials

  In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.

• Successfully Delivering Critical Stem Cell Samples Across The Globe

  To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.

• A Guide To Pharmaceutical Quality Management

  Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

• Liquid Handling Solutions For Bulk Drug Substance Management

  How modern containment technologies optimize and streamline bulk drug substance management workflows while ensuring substance integrity and safety.

• Focus On Your Core Business Strategy

  Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.

• The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• Distribution Of The First Commercial CAR-T Therapy From USA To Japan

  Examine the first commercial live shipment of temperature-critical autologous final CAR-T drug product from a USA manufacturing site to a hospital in Japan.