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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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What FDA Expects to See as Part of Your CAPA Process Cheatsheet

what-fda-expects-to-see-as-capa

If an FDA inspector is coming into your facility for an audit, you can bet they will want to look over your CAPA paperwork and processes. Here's what they expect to see. 

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