Records Management

WHITE PAPERS AND CASE STUDIES

• Pivot From A Struggling Industry To New Opportunities: How To Make Your Own Success

  In this edition, learn how a blockchain and AI application developer quickly adapted an existing solution focused on a challenged industry (oil and gas) to provide a much-needed solution for health care and other essential workers on the front line of the COVID-19 pandemic.

• Medical Device Sponsor Deploys Medrio EDC And Yields A Multitude Of Immediate Benefits

  Medi-Tate Ltd., a medical device company based in Israel, was regularly using a paper-based process for collecting and managing data in clinical studies of its flagship product, the iTind system for treatment of BPH. By choosing Medrio as their introduction to EDC, they were able to take advantage of rapid study build functionality, remote monitoring capabilities, and top-tier training and support.

• From Bench To Billions: Facilitating Scale-Up Of Adherent Cultures For Cell And Gene Therapies

  We review what researchers should consider when they are creating a risk-mitigating adherent culture process for cell and gene therapy scale-up.

• Digitizing Your Clinical Drug Development Process

  Review the usage of MES in pharmaceutical manufacturing, through the drug production lifecycle, from preclinical to commercial and consider MES capabilities in the context of clinical needs and priorities.

• Beautiful Bull Shoals — And The Wastewater Treatment Plant — Just A Stone’s Throw Away

  We all love it when a plan comes together. In July 1952 in Arkansas, when President Harry S. Truman dedicated the Bull Shoals dam on the White River, which created Bull Shoals Lake, it, as planned, brought about a boom in tourism — and how.

• Modernizing Stormwater Permit Inspections With Mobile Applications

  In Collierville, Tennessee, stormwater inspections relied on manually transcribing data from paper-based forms into a digitally managed database. When updates to the database form were needed, no one knew how to fix it, and the budget wouldn’t support hiring someone. An easy-to-use mobile data collection app supported a digital transformation of the inspection workflow, saving time, boosting data accuracy, and reducing inspection times more than 50 percent. 

• 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.

• Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy

  Learn about implementing automated technologies like robotics to overcome growing issues with sterility assurance and data integrity.

• Vanderbilt’s Advice For Sponsors: How To Make Working With Your EDC Easier For Sites

  Learn how research sites like Vanderbilt University Medical Center speed study timelines and drive higher quality data entry with a modern EDC.

• Embracing... Septage?

  Two things are perhaps certain about septage: it is highly variable; and, by its very nature — spewing odorous compounds and elements that can cause disease — it is ‘objectionable.’ Or is it?

• The Evolution Of The Modern Medical Monitor

  How to identify, hire, and empower a modern medical monitor to help your next study proceed toward submission more productively, and with greater data integrity, than ever before.

• Facilitating 21 CFR Part 11 Compliance With Bioprocessing Automation Software

  How Bio4C Orchestrator™ Software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.