Designed for CFR 21 part 11 Compliance

SOLABS QM system is a web-based quality management software enabling companies to improve regulatory compliance and productivity; reduce cycle time and costs by centralizing data, issues and actions. The QM lets you handle all processes and events using just one flexible and user-friendly system. This unique consolidation and streamlining eliminates repetitive work, reduces data entry errors and makes compliance traceability easier than ever.

What Makes SOLABS QM Quality Management System Unique?

• One system including 3 inter-linked modules for Processes, Document Management and Training Records.
• Connection with other systems such as ERP or LIMS system.
• Unlimited number of users.
• Designed specifically to meet Life Science requirements.
• Entirely configurable to adapt to company-specific requirements for processes.
• Access to system from day one.
• Complete validation package as per GAMP5.
• Fast Track deployment based on good Project management practice (roll-out guide available)
  

	Processes: CAPA, Complaints, Deviations, Change Control, etc. The Process inter-linked module allows you to track and monitor quality events such as CAPA, Deviations and Change Control using a flowchart approach clearly assigning responsibilities and time lines at each step. Documents and processes can easily be linked.
	Document Management The Document Management inter-linked module is designed to manage any document types and formats and to setup and track reviews/approvals and publication of official documents such as SOPs.
	Training Records The Training Record inter-linked module lets you setup and manage multiple course outlines and materials, job requirements, as well as track trainings with evaluations.

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