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DocQC™ is a tool for automation of Quality Control (QC) checks that have historically required multiple, time-consuming cycles of manual review. Checks of various complexities are programmed leveraging cutting-edge technologies. These checks are augmented with Artificial Intelligence and Machine Learning algorithms guided and trained by your document subject matter experts to increase efficiency and effectiveness of your QC process with each use. DocQC™ enables your Medical Writers to maintain their focus on the science, analyses, and presentation of results.

DocQC™ streamlines the document QC process automating the execution and reporting of standard checks. This enables Medical Writers to focus on the science, analyses, and generation of results.

Key Features

  • User-friendly interface for viewing and managing your QC check repository across several levels (Global Study)
  • Repository contains standard checks “out of the box”
  • Real-time and batch/scheduled execution options
  • Checks executed automatically on new versions/updates of documents
  • QC Reports generated to detail failed checks, instances and locations for the QC reviewer
  • Performance Metrics Reports to track quality of your documents and your processes across QC phases (i.e., initial through final)

Functionality

  • Ability to execute complex QC checks on items referencing source information in other sections of the document and/or other documents altogether
  • Ability to compare documents to source:
    o Tables/Figures/Listings (TFLs)
    o Datasets (e.g., SDTM, ADaM)
    o Patient Safety Narratives
    o High-Level Summary documents
    o Clinical Study Reports (CSRs)
    o Risk Management Plans (RMPs)
    o Publications and posters
  • Flexibility to accommodate documents of different types, e.g., PDF®, MS Word®, etc
  • Ability to automatically apply standard QC checks
  • Custom checks can be added to make your QC process more powerful and tailored to meet the specific needs of your organization’s standards/templates:
    o Taxonomies
    o Configurable QC checks engine
    o Ability to add new/custom QC checks
  • Configurable Rule Engine