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

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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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

Get a personalized demo of Greenlight Guru Clinical today.

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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FREE ON-DEMAND WEBINAR
September 5, 2023

How to Validate an Electronic Data Capture Setup for a Medical Device Clinical Investigation

System validation and study setup validation are integral to maintaining the highest standards of quality and regulatory compliance in the medical device industry.

While these two processes differ in scope, they are equally important. In this free webinar, we explore key differences between system validation and study validation and why they are both foundational to creating and maintaining high-quality, effective, and safe medical devices.

Join us and discover best practices to validate an EDC system as well as your study setup to avoid discrepancies, compliance issues and ensure data integrity and accuracy.

 
 

Watch the webinar
GG_ST_Validation Webinar 09-05-2023
Specifically, this webinar will cover:
  • System Validation vs. Study (setup) Validation (UAT)
  • IQ vs OQ vs PQ
  • Why a pre-validated system saves time and resources
  • Study Validation templates, SOPs, WIs
Who should attend? 
  • Clinical Affairs/Operations Professionals & Management
  • Regulatory Affairs Professionals & Management
  • Medical Device Executives
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Hosted by

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Moderator:
ETIENNE NICHOLS

Medical Device Guru,
Greenlight Guru
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Presenter:
RASMUS BLENDAL

Product Manager,
SMART-TRIAL by Greenlight Guru
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Presenter:
KIMBERLEY LAU

Solutions Engineer,
SMART-TRIAL by Greenlight Guru

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

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About SMART-TRIAL by Greenlight Guru

The only Electronic Data Capture (EDC) platform designed for Medical Devices & Diagnostics. SMART-TRIAL by Greenlight Guru offers the ideal Electronic Data Capture for clinical investigations, performance studies, and PMCF/PMPF activities - including registries and surveys. Our solution is built to empower clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.

Visit our page to learn more.

Since June 2022, SMART-TRIAL is a Greenlight Guru product.

 

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