Compliance

PRODUCTS

  • Pharmaceutical labeling and kitting are critical for ensuring drug safety, compliance, and efficiency. Explore advanced technology and regulatory adherence to streamline these processes.

  • The MM1-0626SSM is a highly linear passive GaAs double balanced MMIC mixer suitable for both up and down-conversion applications.

  • As cell and gene therapies continue to transform modern medicine, Cryoport Systems evolves its products and solutions to meet the needs of the industry and the patients it serves.

  • Qorvo's QPA0015 is a powerful Ku-Band MMIC amplifier fabricated using their advanced GaN-on-SiC process. Designed for Satcom applications, it delivers 3 Watts of linear power with excellent intermodulation distortion performance.

  • New to the TrialKit platform, TrialKit PACS enables researchers to access, engage with, and oversee clinical trial imaging seamlessly within the same system utilized for managing all other study data.

WHITE PAPERS AND CASE STUDIES

  • Eliminating Data Integrity Errors Through Digitization

    Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.

  • Continuous Flow — An Emerging Alternative

    Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

  • 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.

  • Accelerated Development Of Solid Oral Dosage Formulation For IND Submission

    This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

  • 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.

  • Petzl America Ascends To The Next Level Of Distribution Petzl America, a leading distributor of climbing, mountaineering and safety equipment, needed to streamline distribution operations in order to continue to meet customer compliance requirements and changes in order fulfillment characteristics. Submitted by Cornerstone Solutions
  • How To Survive An FDA Audit

    Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

  • Expectations On The Pathway To GMP For Gene-Modified Cell Therapies

    Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.

  • GFI Case Study: Elgin Community College Uses GFI MailArchiver To Comply With E-Discovery Laws Elgin Community College is an educational institution in Elgin, Illinois offering first-class education from certificate to degree level. Changes to compliance and e-discovery regulations meant that the college required a system that allowed it to be in a position to provide electronic data should it be required as evidence in a civil or criminal legal case. To this end, the College installed GFI MailArchiver, an email management and archiving software.
  • A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
  • Intelligent Workflow From Farm To Processing At Dobler & Sons

    Dobler & Sons has incorporated a fleet management system to comply with the recent ELD mandate and to improve overall efficiency in managing it’s fleet and team of drivers.

  • How ABB's Flow And Digital Technologies Help Bawat With Smarter Ballast Water Compliance

    The International Maritime Organization (IMO) sets strict global standards for ballast water management to prevent the spread of harmful aquatic organisms. For companies like Bawat, a Danish innovator in ballast water management, being able to verify ballast water flow measurements quickly, accurately, and from anywhere in the world is essential.

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