Compliance

WHITE PAPERS AND CASE STUDIES

• Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing

  Discover how adhering to strict GMP guidelines and advanced equipment design ensures that complex, sterile cell and gene therapies are safely and effectively delivered.

• Case Study: Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
• Replacing A Paper-Based GMP System With An Electronic Monitoring System

  As a trusted source of innovative solutions in clinical diagnostics, Fujirebio Diagnostics' sought to replace an its paper-based GMP record system and manual process with an electronic monitoring system.

• PCI Compliance: Xirrus Releases Wi-Fi And Payment Card Industry (PCI) Compliance Whitepaper And Tools Xirrus, Inc., the only provider of high-performance, long-range Wi-Fi products, announced recently the availability of a new tool and whitepaper explaining the PCI (Payment Card Industry) Data Security Standard for companies that use Wi-Fi and handle payment card information.
• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• 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
• 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...
• 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.

• New EH&E White Paper Evaluates Web-based Environmental Health & Safety Training For Laboratory Applications A new free white paper entitled “The Role of Web-based Health and Safety Training in Laboratory Facilities,” is available to help companies, institutions, and universities evaluate the efficacy of using web-based environmental health and safety (EH&S) training to meet their compliance requirements
• Ensuring Compliance With Part 11: A Site's Perspective

  As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

• 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.

• 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)