Establish a new direction for enterprise compliance with the proven QUMAS solution

Addresses manufacturing/ quality issues and delivers packaged submissions management with best practices and built-in compliance features for:

• Quality Management Solutions
  • SOP Management (Policies and Procedures)
  • CAPA
  • Customer Complaints
  • Deviation Management
  • Change Control
  • Policy Training and Certification
• R&D
  • eCTD Management
  • Submissions Management
  • Enterprise Scanning Solution

Addresses the needs of the compliance department with an integrated view of all compliance activity and enables a risk-based approach across the enterprise for:

• Regulatory/Legislative Change Control
• Policies and Procedures
• Exceptions Management/Investigations/Issues Tracking
• Compliance Training Management

Provides a comprehensive framework to achieve sustainable compliance supporting the most stringent requirements such as:

• 21 CFR Parts 11; 210; 820; 600
• ISO standards (9000; 1400)
• GxP practices

Provides a comprehensive framework to achieve sustainable compliance supporting the most stringent requirements such as:

• AML / Patriot Act/3MLD/JMLSG
• Basel II
• Control Room
• Fed Examination Manuals
• Governance
• Regulatory Capital
• SRO requirements, MiFID, TCF
• Sarbanes-Oxley/Listing Rules
• SEC Rules