Compliance

WHITE PAPERS AND CASE STUDIES

• Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
• Serialization And Traceability Compliance In Pharma And Med Device

  Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

• Data Collaboration Helps Novavax Accelerate Vaccine Production

  How and why this late-stage biotech implemented a data collaboration platform, Driven by its COVID-19 vaccine development and manufacturing data management complexities.

• White Paper: The Impact Of The Internet On Compliance Education I sat with astonishment as the compliance officer of a large corporation told me that he had no idea what compliance education was being performed on a day-to-day basis within his organization. He went on to indicate that his company could not produce reliable documented evidence that its employees had in fact, completed federally mandated education
• 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...
• 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)
• 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: Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
• Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• Remote ECG Solution Enables A Fully Decentralized ME/CFS Phase 2 Trial

  Explore the transformative potential of digital health tools in addressing longstanding accessibility challenges in ME/CFS research and beyond.

• Making Money With Security Awareness Training

  How addressing human error reduces risk and bolsters your profitability.

• 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.