Qualio+
Quality-as-a-Service

Qualio+ gives you our best-in-class eQMS software,
plus expert quality assurance support to help you
get to market faster.

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Ready-to-go regulatory content

Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.

 
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Powerful eQMS

Use Qualio to build a world class electronic quality management system, from documents and design controls to training and events.

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Quality assurance experts

Work with our team of seasoned quality experts to ensure you meet - and exceed - your QA goals every time.

OUR QUALITY TEAM

Meet your quality support team
The Qualio+ team combines commitment to your
success with a wealth of life science quality experience.
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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.

Kelly Stanton

Director of Quality

Jerry

Jerry has 15+ years of experience in pharmaceutical, biotechnology and diagnostic laboratory environments, and joined Qualio after 3 years consulting for the CDC.

Jerry Adatsi

Senior Quality Specialist

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Ezra brings nearly 10 years of quality experience to his role at Qualio. He’s led teams across the industry through FDA compliance journeys, rigorous audits and cloud-based QMS builds.

Ezra Kelderman

Quality Engineering Manager

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Meg has amassed over a decade of experience as a QA/RA and compliance professional, with a range of cross-functional skills and knowledge spanning from non-profits to start-ups.

 

Meg Sinclair

Senior Quality Specialist

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Amanda has almost 10 years' experience in pharmaceutical, biotechnology and medical device environments, in roles from engineering to quality assurance. Before joining Qualio, Amanda was a QA Manager at an SaMD start-up.

 

Amanda Inks

Senior Quality Specialist

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Molly brings 8 years of quality knowledge to the Qualio+ team, which she's gained from working in the pharmaceutical, medical device and laboratory fields. Molly is particularly experienced with FDA, HPRA, MDSAP and ISO 13845 audits.

 

Molly Calvey

Senior Quality Specialist

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Sumatha has 18 years of industrial experience in quality assurance and regulatory affairs. Sumatha has built quality management systems for medical device, pharmaceutical, bioanalytical, pre-clinical and clinical study companies, and is also a seasoned auditor for ISO 13485, ISO 9001 and ISO 17025.

Sumatha Kondabolu

Senior Quality Specialist

Best practice quality management

Choose the support you need from our QA experts.

Qualio+

Get tailored expert support from our team of quality assurance advisors to ensure you reach your goals.

  • ISO/FDA audit-ready eQMS
  • Strategy sessions
  • QA support
  • eQMS training
  • Market intelligence
  • Gap assessment
  • Internal audit
  • Supplier audit

Qualio+ Audit

Preparing for an audit? Get all the services of Qualio+ alongside expert audit support to make your audit successful and stress-free.

  • ISO/FDA audit-ready eQMS
  • Strategy sessions
  • QA support
  • eQMS training
  • Market intelligence
  • Gap assessment
  • Internal audit
  • Supplier audit
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