Kelly leads Qualio’s in-house quality team and spearheads our Qualio+ offering. Kelly has built over 20 years of experience working with quality teams at Abbott, Sandoz, Cochlear and more, before becoming Qualio's Director of Quality.
Articles by Kelly Stanton
Podcast
Ernie Wallerstein, Jr., CEO of Mental Health Technologies
How can technology be used to treat - and even model and predict - mental health? Ernie Wallerstein, CEO of Mental Health Technologies, thinks he has the answer.
Kelly StantonApr 18, 2023
Podcast
Enabling the next generation of biomarker discovery with Dr. Mo Jain, CEO of Sapient
The best lifesaving drugs only work 50% of the time. The reason? Broad-stroke treatments that gloss over the individual variations in our bodies. Dr. Mo Jain's Sapient wants to change all that.
Kelly StantonApr 5, 2023
Podcast
Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health
Today we’re talking to Mehdi Maghsoodnia, Co-founder of 1Health which is a personalized precision medicine powered by a lab testing platform that...
Kelly StantonDec 20, 2022
Podcast
Modernizing the Lab with Nathan Clark Cofounder of Ganymede
Nathan Clark of Ganymede talks about how the biotech lab of the future will look like on From Lab to Launch
Kelly StantonDec 9, 2022
Computerized System Assurance
Qualio launches new validation approach
We've updated our validation approach to stay aligned with best practice and give our customers a faster, stress-free experience. Find out what we've changed!
Kelly StantonOct 19, 2022
Medical Devices
What is a bill of materials? A guide for medical devices
A bill of materials is a list of components needed to manufacture your medical device. Learn why you need a BOM, how to create one and different BOM types.
Kelly StantonSep 15, 2022
Podcast
Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn
Ever wondered about your genes and overall health? In today's episode, we will talk about just that. with Dr. J Dunn. We go over wholistic kinesiology...
Kelly StantonSep 9, 2022
Compliance
21 CFR Part 11: Compliance in the supply chain [Checklist]
Manufacturers must comply with 21 CFR Part 11, which includes documentation for supplier and logistics companies. Learn more and get our compliance checklist.
Kelly StantonAug 30, 2022
Compliance
21 CFR Part 11: A guide for clinical trial compliance
Compliance with 21 CFR Part 11 is always required throughout the clinical trial process. Learn how sponsors, CROs and sites can comply with 21 CFR Part 11.
Kelly StantonAug 10, 2022
GxP
What is an electronic batch record?
An electronic batch record is a system that substitutes the use of paper by digitizing said records. Find out the benefits of using electronic batch records and going paperless.
Kelly StantonAug 1, 2022
Pharmaceutical
Biotech vs pharma: Differences and similarities
Explore the differences in biotech vs. pharma companies when it comes to regulations and approvals. And learn how to start a pharma or biotech startup.
Kelly StantonJun 16, 2022
Podcast
The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies
Lyn Yaffe, M.D., was instrumental to the development of the concept of EPR during the research and development work at the Safar Center of Resuscitation...
Kelly StantonMay 6, 2022
eQMS
Tips for moving from a paper-based QMS to an eQMS
Make the switch from a paper-based quality management system to a digital eQMS. Follow these tips to make a painless transition from paper to digital.
Kelly StantonFeb 22, 2022
iso9001
The Risks of ISO 9001 Nonconformance
In this post, you'll learn how to identify the nonconformance discoveries that matter, common issues with ISO 9001:2015 standards and more.
Kelly StantonAug 24, 2021
eQMS
Identifying the 4 Most Common Problems With Your CAPA Process
What are the most common problems that occur within CAPA processes? Learn how to identify issues before they start and how to avoid them...
Kelly StantonJul 22, 2021
eQMS
5 Major Total Quality Management Principles for Medical Device Startups
What are the most vital total quality management principles for medical device startups to follow? Learn how successful new medical startups...
Kelly StantonJul 20, 2021
Medical Devices
Regulatory Expectations for Software as a Medical Device (SaMD) Startups
What are the regulatory expectations for software as a medical device (SaMD) startup companies? Learn which requirements SaMD companies...
Kelly StantonJul 15, 2021
Pharmaceutical
What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?
What are the key differences between biopharmaceutical and pharmaceutical startups? Biopharma and traditional pharma startups both share...
Kelly StantonJul 8, 2021
Medical Devices
3 Important FDA Medical Device Guidance Documents to Bookmark
What are the most important medical device guidance documents that your life science organization should bookmark? Start by...
Kelly StantonJun 3, 2021
Pharmaceutical
The Top 3 Pharmaceutical Venture Capital Firms
Are you in investment banking for the pharmaceuticals industry? Here are the top companies to watch, including...
Kelly StantonMay 20, 2021
ISO 13485
What is the ISO 13485 Quality Manual?
An ISO 13485 Quality Manual is critical for medical device manufacturers to prove compliance with...
Kelly StantonMay 13, 2021
Pharmaceutical
Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance
Proper biopharma quality management can guarantee regulatory compliance. Follow these 5 steps to...
Kelly StantonMay 11, 2021
Medical Devices
4 Major Class II Medical Device Requirements
Looking for Class II medical device requirements? We've compiled the largest requirements that send many teams back to the drawing board...
Kelly StantonMay 6, 2021
FDA
What is the FDA 21 CFR? Requirements Overview
Need information on FDA 21 CFR? Simply put, the Code of Federal Regulations, Title 21 is...
Kelly StantonMay 6, 2021
eQMS
How to Build a Document Control Procedures Manual
Is your life sciences organization struggling with document control? Learn how to build a document control procedures manual to...
Kelly StantonApr 29, 2021
Pharmaceutical
How to Master Pharmaceutical QA in 4 Simple Steps
Are you struggling with pharmaceutical QA? Follow these simple steps to master pharmaceutical QA and...
Kelly StantonApr 6, 2021
Updates
Qualio is Officially ISO 9001 Certified!
Qualio is officially ISO 9001 Certified.
Kelly StantonFeb 1, 2021
Pharmaceutical
What Are The 4 Phases of Clinical Trials? (And How to Guarantee Quality Assurance During Every Step)
Learn about the 4 phases of clinical trials and what mistakes many life science companies make..
Kelly StantonMay 7, 2020