Compliance

WHITE PAPERS AND CASE STUDIES

• AIIM 2004: In Comes Compliance, Out Goes The Cash As he made the rounds at AIIM Expo 2004, Chief Editor Tom von Gunden found vendors offering — and end users ready to buy — ECM, BPM, and ILM solutions targeting compliance-driven needs.
• Set Up And Qualify GMP Laboratories

  See how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

• Have Confidence In Your Bio/Pharma Data

  The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.

• Online Total Nitrogen Analysis Of Reverse Osmosis Reject Water Reduces Permit Compliance Expense By $350,000 Annually At Beverage Bottling Plant

  Learn how a beverage plant cut its annual Reverse Osmosis reject water hauling volume by 50%. Real-time Total Nitrogen monitoring reduced compliance costs by $350,000 and eliminated discharge penalty risk.

• Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
• 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.

• Overcoming Obstacles To Deliver Critical Autologous Cell Therapy

  See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany

• 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
• Regulatory Compliance: Weighing In Pharma Manufacturing

  Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.

• Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot

  Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.

• 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.