Compliance

WHITE PAPERS AND CASE STUDIES

• 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.

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• 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
• Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Physicians Medical Group of Santa Cruz County (PMG) cut its claims processing time by more than half and provided faster access to data, fewer compliance concerns, happier employees and more satisfied customers with an integrated solution from Datacap and Bowe Bell & Howell. Submitted by Datacap
• Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

  Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

• Q&A: Payment Processing With Precidia Technologies Precidia has issued several press releases, through late 2008 and early 2009 regarding the TransNet solution. What is your strategy with this product? In introducing TransNet, we are offering the market an alternative to the established integrated payment model. Our solution addresses some of the limitations of the...
• GFI Case Study: GFI MailEssentials & GFI MailArchiver Machine Solutions Inc. an Arizona-based manufacturer of medical product testing equipment, was faced with two email-related issues: first, the ever-increasing volume of spam that was reaching the company and second, the problems associated with cumbersome .pst files and the lack of a real-time archiving system.
• How Social Technologies Are Creating A New Paradigm For Addressing Business Objectives

  This case study investigates how Within3 supported a culture of innovation by introducing three pharmaceutical companies to secure, regulatory-compliant virtual advisory boards. By Within3

• Solutions To Global Pharmaceutical Supply Chain Challenges

  The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and speed to market.

• 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.

• Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine

  As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.

• Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

  Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.