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Greenlight Guru Validation

The document discusses Greenlight Guru's Quality Management software and its approach to software validation. Greenlight Guru provides a comprehensive software validation package that includes intended use statements, validated test reports, test case summaries, templates, and an installation qualification protocol to simplify validation for customers. This risk-based approach aligns with FDA and ISO guidance and allows customers to more efficiently implement quality management systems while maintaining compliance.

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HDL Cravinhos
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77 views3 pages

Greenlight Guru Validation

The document discusses Greenlight Guru's Quality Management software and its approach to software validation. Greenlight Guru provides a comprehensive software validation package that includes intended use statements, validated test reports, test case summaries, templates, and an installation qualification protocol to simplify validation for customers. This risk-based approach aligns with FDA and ISO guidance and allows customers to more efficiently implement quality management systems while maintaining compliance.

Uploaded by

HDL Cravinhos
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Greenlight Guru

Quality Management (QMS) Software

SOFTWARE VALIDATION

Efficient & Compliant


System Validation
Software validation has been an extensive and cumbersome
“ The vast majority of software
platforms are not built for medical
device companies and therefore
process for even the most well-equipped companies. require painstakingly hard and
time-consuming validation
Greenlight Guru’s risk-based approach to validating our Quality processes. With Greenlight Guru,
Management (QMS) software embodies a modernized, we do not have to do any of that.”
automated software validation process. Our complete Software
Mary Head,
Validation Package enables teams to implement and adopt the ISO 13485:2016 Lead Auditor and
latest enhancements and functionality efficiently while assuring Document Control Team Lead at DNAe
compliance with evolving validation requirements.

Evolving Requirements: Computer Software Assurance (CSA) vs Computer System Validation (CSV)
The FDA’s latest draft guidance on software validation has signaled a major shift in the way FDA is thinking about
the process of software validation in MedTech. It’s part of a broad industry shift away from the older method of
software validation—computer system validation (CSV)—to the newer, risk-based approach known as computer
software assurance (CSA).

Computer system validation is a form of software validation that relies heavily on testing to provide the “objective
evidence” FDA requires to confirm the software meets its user needs and intended uses.

Computer software assurance is a risk-based approach to software validation. Rather than spending the same
amount of time testing every piece of software they use, CSA encourages companies to select more rigorous
assurance activities for software that poses higher risks. It also brings FDA guidance more in line with ISO
13485:2016, which also gives direction on leveraging a risk-based approach.

Computer Computer
Software Documentation System Documentation
Assurance Validation
Testing Testing

Software Assurance Software Assurance

Critical Thinking Critical Thinking

www.greenlight.guru
Greenlight Guru
Quality Management (QMS) Software

Modern Validation for Modern Software


Our platform is designed for medical device companies' specific
needs and considers applicable requirements defined in FDA 21
CFR Part 820 and ISO 13485:2016.
“ The shift from CSV to CSA is a
move toward a more balanced, risk-
based approach to software
validation. We’re excited to be
The platform is tested and validated in accordance with the modernizing our validation
approach at Greenlight Guru
FDA’s guidance for Computer Software Assurance (CSA) and
because it will allow us to release
ISO/TR 80002-2:2017 requirements and best practices for
software faster and improve the
software validation. pace of innovation without
jeopardizing compliance for our
What’s Included in Greenlight Guru’s Validation Package
customers. It also streamlines the
 Intended Use Statements implementation of our QMS
solution for customers, which is a
 Validated Test Reports
win for everyone.
 Test Case Summaries
 Memos/Templates Brian Gaffney,
CTO of Greenlight Guru
 Installation Qualification (IQ) Protocol

Greenlight Guru does the heavy lifting


Greenlight Guru is committed to taking on the heavy lifting of software validation for our customers by providing an
always-updated Validation Package with our software. This reduces the amount of time our customers need to
spend on validation, enabling them to get the most out of using purpose-built software solutions and focus on what
they do best: bringing life-changing medical devices to market.

Complete Software Validation


Automated Testing as part Ongoing communication and
GG of QMS development
Package with automated test
support with each update
results, memos, and templates

Greenlight Guru validated


and ready for use

Outline Master Validation Review & route Validation


Customer Plan for company needs
Complete IQ protocol
Report

www.greenlight.guru
Greenlight Guru
Quality Management (QMS) Software

With the provided intended use statements and our Validation Report, Greenlight Guru
customers have the ease of reviewing those to ensure they align with their use of the
Greenlight Guru software, then simply routing for approval in Greenlight Guru’s
Document Management workspace to provide objective evidence for compliance.

Key Benefits

Unlock Efficiency
Streamline the implementation of your electronic quality management system
(eQMS) with a comprehensive validation package that documented

Save Resources
Eliminate the time and resources spent on system validation documentation

Risk-based Compliance
Assure compliance assurance with FDA CSA guidance and alignment with other
global regulatory bodies; Continuous testing and routinely updated

Embrace the digital transformation


Benefit from continuous innovation offered by true SaaS-based technology
providers

Greenlight Guru Customers Experience

75% reduction in time Continued updates and Compliance


or QMS implementation validation done in minutes assured

Learn Why Every Customer Relies On Our Validation Package.


With Greenlight Guru, you can spend your time on the things that matter, rather than more compliance-heavy
paperwork and complex validation protocols for software intended to make your life easier. Our validation approach
does everything for you that software vendors should do while providing you the resources you need.

www.greenlight.guru

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