Compliance

WHITE PAPERS AND CASE STUDIES

• The Potential Return On Investment Of Using ePROs Over Paper In Clinical Trials

  Industry perception is that the start-up costs of implementing an ePRO platform may dwarf the cost of printing and distributing paper diaries by as much as 10 times. However, this does not take into consideration the significant value and return on investment that adopting ePRO technology has had on overall clinical trial costs and timelines due to improvements in data quality and completeness, participant retention and compliance, and study and site efficiency.

• Turning New Regulations Into IoT Opportunity: How To Become A Trusted Business Partner

  In this edition, learn how a technology vendor recognized a need in the market after new industry regulations were introduced and transformed into a trusted business advisor and broader tech expert.

• 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.
• Bertucci's Proactively Secures Its Point Of Sale Systems And Corporate Computers With Bit9 Whitelisting And Device Control

  Bertucci’s has become a beloved destination for Italian food since its formation in 1981.With more than 2,000 employees in over 90 restaurants, managing unauthorized software downloads on their growing computer systems became a daunting task.

• White Paper: The 5 Pitfalls Of Implementing Project And Workflow Management Software The benefits of implementing an end-to-end project and workflow management system may seem like a panacea to executives and senior managers. Operational efficiencies and increased collaboration among employees may result, along with improved compliance and a comprehensive real-time view of operations for rapid executive decision making.
• 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.

• 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.

• USP <665> Becomes Official On May 1, 2026. Are You Ready?

  With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.

• California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
• Safety First In The Field!

  Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.

• 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.

• Developing An Organizational Roadmap For Post Authorization Safety Studies

  Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.