NetRegulus Quality

Complaints

  • Manage the investigation and resolution of customer complaints
  • Maintain customer and product information
  • Provide a workflow and review process with issue resolution and system notifications
  • Configure decision tree elements for Regulatory Reporting Decisions, Risk Assessments and other key functions
  • Generate form letters and regulatory reports using pre-populated templates
  • Associate multiple products, manufacturing sites, vendors or classifications to each complaint
  • Attach electronic files, photos and other documents
  • Generate standard regulatory reports including MedWatch, Vigilance, and Canada PRF
  • Support MedWatch Alternative Summary Reporting
  • Maintain a library of standard text phrases to be used anywhere across the Complaints record
  • Track product movement within the organization
  • Add workflow elements on the fly from a library of optional actions, including decontamination, product evaluation, failure investigation, disposition and others
  • Manage activities, cancel or reassign actions and change due dates. The powerful workflow engine maintains a full audit trail and rationale documentation
  • All field labels, tab labels, menu items, form text (warnings, errors, etc) are user/administration configurable to match your own terminology
  • Powerful and fully-integrated Reporting Tool lets users generate their own data sets and export to Excel or other commonly used data files
  • User configurable reports with e-mail distribution, scheduling and graphing capabilities

Corrective and Preventive Actions / CAPA

  • Link multiple issues from various sources to each corrective or preventive action including complaints, nonconformance, audit findings and other quality issues
  • Design your own classification schema to facilitate trend analysis
  • Add multiple classifications to each CAPA record and use data to follow trends
  • Includes multiple decision trees for risk assessment, investigations and effectiveness checks
  • Generate a Corrective Action or Preventive Action request
  • Generate multiple reports automatically
  • Assign and track all tasks through closure
  • Provide notifications and alerts of overdue investigations

Nonconformance Reporting

  • Manage all steps in the nonconformance process
  • Generate Corrective Actions and track them through completion
  • Classify nonconformances easily and consistently
  • Add multiple lot numbers, serial numbers, materials, parts or products
  • Assign and track action items for each activity and role
  • Electronic approvals and signatures

Audit

  • Manage internal and external audits with the scheduling tool
  • Document findings and actions directly to the issue record to ensure data integrity
  • Identify trends before they become nonconformance or customer complaints
  • Links to CAPA module for corrective action follow-up
Adverse Events Manager

Manage adverse events, including initiation, triage, validation, medical review, submissions and closure. Query and mine data and conduct analyses of similar events. Adverse Events can also be launched directly from the Study Data Manger or the Complaints modules.

NetRegulus Technical Support