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Company description

Scilife is a smart Quality Management System (QMS) software platform purpose-built for the life sciences industry. Trusted by leading quality-focused organizations, Scilife helps companies digitize and automate quality processes, eliminate complexity, and achieve end-to-end traceability and data integrity compliance — all within a unified, collaborative workflow. The platform is designed to eliminate up to 80% of complex quality assurance tasks, turning quality into a strategic asset rather than a burden.

Scilife serves a broad range of life sciences sectors, including Pharma and Biotech, Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), Medicinal Cannabis producers, Medical Device and IVD manufacturers, and Advanced Therapy Medicinal Product (ATMP) developers. Each industry segment benefits from tailored capabilities that address its unique regulatory and operational challenges.

Smart QMS Solution

• Document and Record Management: Digitalize document processes and maintain consistent, reliable records across the organization, eliminating spreadsheet chaos and creating a unified data repository.
• Compliance Training Automation: Automate training cycles to ensure staff are always up to date with the latest procedures and regulatory requirements.
• CAPA, Deviations, and Nonconformities: Manage corrective and preventive actions, deviations, and nonconformities seamlessly to maintain audit readiness at all times.
• Change Control and Risk Assessments: Integrate change control processes and risk assessments for comprehensive quality oversight and reduced compliance risk.
• Quality Metrics and KPIs: Monitor real-time quality metrics to hit performance targets, foster collaboration, and promote shared ownership of quality initiatives across teams.

Smart QMS Solution for Medical Devices

• Design and Development Traceability: Eliminate confusion in tracking design and development elements, accelerating time-to-market by up to 35% through streamlined workflows and version control.
• Traceability Matrix: Automatically link risk assessments and connect thousands of items with a single click, showing how design inputs relate to user needs and assessing the impact of design changes on validation and verification processes.
• ISO 13485 Compliance: The platform is fully compliant with ISO 13485, supporting simplified regulatory submissions and rapid approvals for medical device manufacturers.
• Efficient Validation Workflows: Streamline validation processes to reduce time and effort while maintaining rigorous documentation standards.

Controlled Printing and Reconciliation (P&R) Solution

• FDA 21 CFR Part 11 Compliance: Ensure fully compliant controlled printing by integrating essential applications for easy tracking and flawless audits in line with FDA 21 CFR 11 requirements.
• Audit Trail: Maintain a spotless, complete audit trail by tracking who printed what, when, and why, with automatic recognition of reprints for full traceability of every print action.
• Barcode-Based Reconciliation: Use unique barcodes to speed up and digitize the reconciliation process, enabling quick identification and resolution of missing documents.

Core Platform Capabilities

• Automated training cycles to keep teams continuously compliant
• Streamlined document and record management processes
• Continuous audit readiness across all quality functions
• Elimination of spreadsheet-based quality management
• Real-time quality metrics and performance dashboards
• Consistent and reliable records with full data integrity
• Efficient validation workflows for regulated environments
• Unified data repository for centralized quality information
• Simplified regulatory submissions and rapid approval cycles
• Reduced overall compliance risk across the organization

Industries Served

• Pharma and Biotech: Nurture a company-wide quality culture and drive continuous improvement across the organization.
• CRO and CMO: Accelerate operational efficiency and ensure clinical trial deadlines are consistently met.
• Medicinal Cannabis: Comply with stringent and rapidly evolving regulatory requirements in this emerging sector.
• Medical Devices and IVD: Bring high-quality medical devices to market faster with robust design control and traceability tools.
• ATMPs: Standardize and track materials and manufacturing processes for advanced therapy medicinal products.

Scilife positions itself as the number one QMS software for life sciences, offering an integrated, intelligent platform that brings clarity, integrity, and compliance to quality management — empowering organizations to make quality their most competitive advantage.

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Software attributed to Scilife

• Smart QMSView
• Smart QMS for Medical DevicesView
• Controlled Printing & ReconciliationView

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