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.

• Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

  As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

• Software Automation In The Blood And Biologics Industry

  Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

• 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.

• Security In The Supply Chain

  When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical

• AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor
• 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?

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• Protect Your Health Records And Meet Your Compliance Obligations Compliance claims made by vendors concerning their products can be misleading. Below are excerpts from HIPAA’s Technical Safeguard’s that refer to requirements that a compliant storage solution should address. In violet are the capabilities Nexsan Assureon provides its customers. Submitted by Nexsan Technologies
• Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Case Study: Physicians Medical Group
• 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...
• 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.