FMD K&L offers a business accelerator, QPLUS, to check document quality and keep your program in high gear
Technology Solutions: Qplus

QPLUS provides the ability to effectively track key performance indicators and furnish real-time feedback and analysis. QPLUS can be applied and customized for use with many types of documents created by various different groups for reporting to both internal and external stakeholders.

For one client, QPLUS was used to check the quality of aggregate reports, including periodic risk/benefit reports (PBRERs), periodic adverse drug experience reports (PADERs), addenda to clinical overviews (ACOs), and ad hoc reports. For this project, FMD K&L developed a checklist confirming that all sections of the reports were complete and that all template and style guidelines had been followed. QPLUS provided feedback to the report writers as appropriate.

Key QPLUS features include:
  • Excel import: enables user to change document verification checklist & verify any type of document ranging from clinical to regulatory to pharmacovigilance
  • Workflow engine: enables user to increase number of review parameters, aiding document review from a high-level to a detailed level
  • Email notification: informs document reviewers that a document has been assigned to them
  • PDF export: enables reports to be generated for analysis
  • Dashboard: enables managers to track team performance, milestones, periodic reviews, quality issues & review delivery