Process Manager™
Plan, monitor business activities to identify bottlenecks, measure effectiveness, control time and costs, improve processes and performance for regulatory compliance.

• Creates investigation questions from standardized or customized procedure
• Guides effective, accurate investigations with smart decision tree analysis
• Triggers to other system modules automatically for Adverse Event Reporting, CAPA, or Regulatory Reporting
• Provides extensive catalogue of US and international standard reports.  Standard reports include MDR, AER for MedWatch.  Upon request, additional reports are available as part of the offering: MDV, MedDRA, PSUR, and CIOMS I, NDA Periodic, IND Safety Update, Yellow Card, BfArM, and VAERS reports.
• Allows fast and simple report generation
• Tracks and archives submission reports to trace case submissions
• Automates and shortens reporting processes, send standard reports to regulators, distributors, and other involved parties with a few clicks

Risk incident inputs are extracted from other QS Labs product modules or from third party vendors of choice, including: TrackWise, IBM WebSphere, EMC Documentum, and Crystal Reports.

See products features and benefits to find out how QS Labs products can help your organization decrease uncertainty and reduce variability in manual driven processes:

For additional information about QS Labs products, please contact us for a product demonstration.