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01Quality 02Manufacturing 03Clinical 04Regulatory 05Supplier 06Product Development 07Postmarket

Quality Solution Overview Document Control Change Control Training Management CAPA Software Deviations Management Nonconformance Out of Specification Audit Management Quality Management Risk Management Data and Analytics Spark QMS for Small Business

Manufacturing Solution Overview Batch Records Device History Records Equipment Calibration Recipe Management System Variant Management Data and Analytics

Clinical Solution Overview Clinical Management Trial Master File Trial Software TMF Checklist

Regulatory Solution Overview Regulatory Information Management (RIM) Submissions for 510(K) and PMA Submissions for eCTD Submissions Management 510K Guidance CTD File

Supplier Solution Overview Supplier Management Bill of Materials Supplier Management Audits Vendor Management Supplier Scorecard Supplier Corrective Action Request Supplier Deviation

Development Solution Overview Design Control Change Control Software Change Management Software Change Order Change Management Tool

Postmarket Solution Overview Customer Complaints Medical Device Reporting (eMDR) Complaint Tracking System Complaint Example Device Reporting Software

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Integrated software solutions for a variety of industries.

Platform

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01Resources 02FDA 03ISO 04Global 05Platform Integrations 06Templates and Guidelines

Resource Center Quality ROI Calculator Manufacturing ROI Calculator Blog - GxP Lifeline Customer Stories Customer Awards

21 CFR Part 11 21 CFR Part 111 21 CFR Part 1270—1271 21 CFR Part 210—211 21 CFR Part 606 21 CFR Part 820

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ERP Software System MRP Software System MES System Manufacturing Resource Planning Production Operations Management LIMS System

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About Us

Who We Are

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