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Stage of Commercialization

Pre-Market

Post-Market

Average / Expected annual revenue per new product

Number / expected number of FTE needed to manage quality and compliance documentation

Number of team members involved in development/design documentation

Time spent on development/design documentation per team member (hours/month)

Average number of internal audits per year

Average number of external audits per year

Average number of findings per external audit

Average / Potential number of quality events per year

How Greenlight Guru Can Help You

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	Increase Operational Efficiencies
	Reduce time to set up a QMS by 75%	$76,387
	Reduce number of FTE required to manage quality and compliance documentation by 1.0	$309,637
	Reduce time spent on product development and design documentation by 50%	$262,292
	Reduce QA/RA FTE time spent on mandatory training by 75%	$84,344
	Mitigate Risk
	Reduce time spent preparing for quality audits by 50%	$101,437
	Reduce number of audit findings by 40% and time to address findings by 25%	$298,876
	Reduce time spent managing quality events by 30%	$67,926
	Reduce labor hours needed per recall/ return/ adverse event by 35%	$0
	Grow/Protect Revenue
	Accelerate time to market by 35% ( 10% attributable to Greenlight Guru eQMS)	$175,000
	Reduce risk of in-market revenue loss by 0.5% ( 30% attributable to Greenlight Guru eQMS)	$0
	Total value over 3 years	$1,375,899

Overall 3-year value created:

$1,375,899

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The Return-on-Investment (ROI) and other financial calculations performed by this tool are based on data provided by Greenlight Guru eQMS customers, and various assumptions, and produce estimates only. The actual ROI realized by customers may vary from the estimates provided. Greenlight Guru offers this tool to assist customers with evaluating their eQMS solution; however, Greenlight Guru and Hobson & Company (the firm that created the tool) are not responsible for the accuracy of any estimates.

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