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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

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

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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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FREE ON-DEMAND WEBINAR
AUGUST 25, 2022

Connecting Computer System Validation to Daily Operations

Starting out in the medical device industry is made much more simple by using a tool like Greenlight Guru.

However, that doesn't mean your day-to-day operations are mapped to how your computer system validation states. Do thoughts of your next audit fill you with dread?

Register for this free, in-depth webinar where Carlos Almeida, District Manager & Vice President, Engineering at SPK and Associates, will walk you through how to manage electronic data in regulated manufacturing/laboratory/clinical environments in compliance with FDA’s 21 CFR Part 11 and map that to day-to-day operations.

Watch the webinar
SPK&Associates webinar 8-25-22
Specifically, this webinar will cover:
  • Learn the general process used to test, validate and document your computerized systems.
  • Gain knowledge around best practices by industry experts through years of CSV work. of CE marking documentation
  • Understand some tips and tricks to enhance your capabilities.
Who should attend?
Startups or those that have minimal knowledge of CSV process and operations related to medical device manufacturing. Register Now  

Hosted by

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Presenter: Carlos Almeida

District Manager & Vice President, Engineering,
SPK and Associates
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Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru

 

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About SPK and Associates

Headquartered in Scotts Valley, CA, SPK and Associates is a leading woman-owned Engineering & IT Services Company that serves product development teams. For over 20 years, SPK has helped clients harness technology to optimize engineering and attain their business goals. With extensive expertise in the medical device/medtech industry, SPK understands the systems, processes, data and applications critical to successful engineering. SPK’s core expertise covers four functional areas: Product Lifecycle Management (MCAD, PLM, PDM); Software Lifecycle Management (ALM, DevOps); Cloud for Engineering (Infrastructure, Security); Data Engineering and Insights. Visit their website to learn more.


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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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