Compliance

PRODUCTS

  • Compliance solutions for product development agility and audit readiness.

  • Companies are under constant pressure to accelerate drug development while managing tight budgets and headcount restrictions. Many turn to temporary staffing, but this model often falls short for long-term needs.

  • PHCbi brand’s 23.7 cu.ft (671 L) upright pharmaceutical refrigerator offers a high-capacity solution for clinical and biomedical storage. Five pull-out drawers provide organized access, while fan-forced air circulation help helps ensures uniform temperature control from 2°C to 23°C. A microprocessor system with alarms helps maintain stability and safety. The shelves can be arranged to accommodate different configurations. The unit is deep and strong enough to hold processing equipment and most devices. It offers optimal performance without compromising efficiency.

  • Expedite your development with our comprehensive suite of GMP services specifically designed to streamline regulatory and get you to market faster.

  • Planning to launch a patient-centric decentralized clinical trial? Give your clinical trial patients an app that makes it easy to participate—from anywhere at any time.

    Simplify clinical trial participation with an integrated eCOA and ePRO solution

    TrialKit’s electronic clinical outcome assessment (eCOA) and electronic patient-reported outcomes (ePRO) platform integrates with all currently available wearables, mobile operating systems, and web applications. Whether you collect data in the clinic, with provisioned devices, or take a bring-your-own-device (BYOD) approach, you can count on seamless data sharing and efficient study execution.

WHITE PAPERS AND CASE STUDIES

  • LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
  • Improving Global Labeling Workflow

    One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.

  • Operationalizing Disclosure Intelligence For Go-To-Market Success

    Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.

  • Green Communication: A Polycom Commitment To The Planet Polycom high definition telepresence, video, and voice solutions are changing the way organizations communicate. And that's a good thing for our planet. Although we may be geographically distant from our fellow workers, customers, and partners, we no longer have to travel to be effective. Thanks to high definition...
  • Case Study: DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
  • Catalent's Journey Of Continuous Improvement For CSV Excellence

    Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

  • Comparative Analysis For Non-IND Sites

    A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.

     

     

  • 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.

  • Bertucci's Proactively Secures Its Point Of Sale Systems And Corporate Computers With Bit9 Whitelisting And Device Control

    Bertucci’s has become a beloved destination for Italian food since its formation in 1981.With more than 2,000 employees in over 90 restaurants, managing unauthorized software downloads on their growing computer systems became a daunting task.

  • Advancing Compliance And Digital Strategy To Align With Pharma 4.0

    AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.

  • 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.

  • PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland

NEWS