Qualio+
Quality as a Service

Qualio+ 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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Regulatory content

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

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eQMS

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

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Quality assurance experts

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

OUR QUALITY TEAM

Meet your Quality Advisors
Our best-in-class software is backed by a best-in-class teamcommitted to your success.
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With 20+ years of experience, Kelly leads Qualio’s in-house Quality team and spearheads our Qualio+ offering. Kelly has worked with Quality teams at Abbott, Sandoz, Cochlear, and more.

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Kelly Stanton

Director of Quality

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

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Jerry Adatsi

Senior Quality Specialist

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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.

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Ezra Kelderman

QA Engineering Manager

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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.

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Meg Sinclair

Senior Quality Specialist

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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.

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Amanda Inks

Senior Quality Specialist

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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.

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Molly Calvey

Senior Quality Specialist

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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.

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Sumatha Kondabolu

Senior Quality Specialist

Best practice quality management

Our QA experts can get your team up-and-running quickly by
building out your full QMS from templates to SOPs and more.

Qualio+

Get expert support to help you succeed. Our team of Quality Assurance advisors 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

For companies focused on audit preparation. Get all the services of Qualio+ in addition to expert audit support.

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