DocuTrack™
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DocuTrack™ is an enterprise-grade Document Archival and Records Management System designed for Pharma, Biopharma, and Medical Device organizations. It delivers complete control over the lifecycle of physical documents while meeting stringent regulatory and compliance requirements.
Salient Features
Salient Features
Lifecycle Governance through Digital Identification
Intelligent Archival Management
Controlled Access & Workflows
Audit Trails & Monitoring
Compliance & Regulatory Readiness
Compliance & Regulatory Readiness
• US FDA 21 CFR Part 11 – Electronic Records & Audit Trails
• EU Annex 11 – Computerized Systems
• ISO 9001 – Quality Management Systems
• ISO 27001 – Information Security Management
• ALCOA+ Principles – Data Integrity
Validation & Inspection Support
Validation & Inspection Support
• Supports IQ, OQ, and PQ validation documentation
• SOP-driven system configuration
• Change control and configuration traceability
• Designed for regulatory inspections and audits
Business Benefits
Business Benefits
• Minimizes risk of document loss and data integrity issues
• Reduces audit preparation time
• Improves operational efficiency and compliance confidence
• Scalable for growing document volumes and regulatory demands
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