Qualio Plus - Quality as a Service

Qualio Plus offers customers our best-in-class eQMS software plus expert Quality Assurance support to help growing companies get to market faster.

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eQMS

Comprehensive eQMS to reach and maintain a state of audit-readiness.

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REGULATORY CONTENT

Pre-configured templates and pre-written documentation for FDA & ISO compliance.

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QA EXPERTS

Access to our team of quality experts to ensure you meet and exceed your QA goals.

Meet your Quality Advisors

Our best-in-class software is backed by a best-in-class team committed to your success.

 With 20+ years of experience, Kelly Stanton leads Qualio’s in-house Quality team and spearheads our Qualio+ offering. Kelly has worked with Quality teams at Abbott, Sandoz, Cochlear, and more.


Learn more about Kelly on LinkedIn.

Kelly Stanton
DIRECTOR OF QUALITY
Jerry has 15+ years of experience in pharmaceutical, biotechnology, and diagnostic laboratory environments. He joins Qualio after spending 3 years consulting for the CDC.
 

Learn more about Jerry on LinkedIn.

Jerry Adatsi
SENIOR QUALITY SPECIALIST
Ezra brings nearly 10 years of experience in Quality to his role at Qualio. He’s led teams across the industry through FDA compliance, audits, and build outs of full cloud-based Quality Management Systems.
 

Learn more about Ezra on LinkedIn.

Ezra Kelderman
QA ENGINEERING MANAGER
Meg has 10+ years as a Quality Assurance, Regulatory Affairs, and Compliance professional with a range of cross-functional skills and experience spanning nonprofits to startups.


Learn more about Meg on LinkedIn.

Meg Sinclair
SENIOR QUALITY SPECIALIST
Amanda has almost 10 years of experience in pharmaceutical, biotechnology, and medical device environments in roles from Engineering to Quality Assurance. Most recently Amanda was a Quality Assurance Manager with an SaMD startup. 
 
Learn more about Amanda on LinkedIn.
 
Amanda Inks
SENIOR QUALITY SPECIALIST
Molly brings 8 years of quality knowledge gained from working in the pharmaceutical, medical device and laboratory fields and has experience with FDA, HPRA, MDSAP and ISO 13845 audits. 
 

Learn more about Molly on LinkedIn.

Molly Calvey
SENIOR QUALITY SPECIALIST
Sumatha has 18 years of industrial experience in Quality assurance, Regulatory Affairs. Established quality management system for Medical Devices, Pharmaceutical Analytical, Bioanalytical, Pre-clinical, and Clinical studies. Sumatha is also an auditor for ISO 13485, ISO 9001, and ISO 17025. 
 

Learn more about Sumatha on LinkedIn.

Sumatha Kondabolu
SENIOR QUALITY SPECIALIST

Best Practice Quality Management

With Qualio Plus, our QA experts get your team up-and-running quickly by building out your full Quality Management System - from templates to SOPs and more.

 

Qualio Plus includes:

  • ISO/FDA audit ready eQMS
  • Strategy sessions
  • QA support
  • eQMS training
  • Market intelligence

Qualio Plus Audit includes:

  • All Qualio Plus services
  • Gap assessment
  • Internal audit
  • Supplier audit

5 star reviews on G2, Capterra, Getapp, and SoftwareAdvice

Consistently ranked as the quality management platform of choice by medical device manufacturers, therapeutics companies and regulated contract service providers.

 

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Get Started With Qualio Plus Today

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Where do you rank on Quality?

Where do you rank on Quality?

Outstanding quality management is the common thread among companies that are successful at avoiding regulatory issues and adept at getting to market quickly.