AUDIT MANAGEMENT

Pass every audit, every time

Make stressful, last-minute audit prep a thing of the past.

Smarter, calmer audits

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Challenge

Internal audits can be burdensome, resource-heavy slogs.

External audits can be stressful nightmares upon which the future of your business rests.

And failing to prepare can lead to fines, penalties or product recalls.

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Solution

Qualio gives your team the tools for 100% audit-readiness at any time.

Access data, prove compliance, demonstrate continuous improvement and report on the status of any findings. Make internal and external audits quick, enjoyable growth drivers - not nail-biting tests.

Be 100% compliant and audit-ready

  • Identify gaps and optimize quality performance with a connected quality ecosystem
  • Have confidence your QMS is fully compliant with ICH Q10, ISO 9001, ISO 13485, ISO 14971, FDA requirements, and the EU MDR (to name a few!)
  • Prove continuous improvement from past audits with organized documents, procedures and automated internal audit schedules and tasks

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Save time with automated document and data processes

  • Ditch the challenges of paper-based audits with a cloud-based, controlled-access eQMS that makes remote audits simple
  • Find all audit artifacts with one click using document templates and tagging
  • Build bespoke workflows to assign tasks and automate reminders from one place
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Make audit readiness your competitive advantage

  • Squash the risk of fines, penalties and product recalls by connecting your data and teams to a centralized single source of quality truth
  • Easily assign audit tasks, manage due dates and track any audit findings to completion 
  • Enjoy end-to-end traceability for all CAPAs, non-conformances, and other quality events to demonstrate complete control and visibility to your auditors
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Audit management resources

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Audit readiness checklist

Pinpoint gaps, take targeted action and get your QMS ready for your next audit.

Get my checklist
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Passing an audit webinar

Hear tips, insight and best practice from a webinar panel of seasoned quality experts.

Watch webinar recording

See other features that make Qualio
the #1 top-rated cloud QMS

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Supplier management

Control and categorize suppliers and third parties with complete visibility.

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Document management

Make paper, filing cabinets, folders and spreadsheets a thing of the past.

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Design control management

Supercharge your product development from a single source of truth.

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Risk management

Detect and mitigate risks and comply with
ISO 14971 and ICH Q9.

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Training management

Build a competent, confident, compliant, continuously improving workforce.

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Change control management

Manage change activity easily and effectively with complete traceability.

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CAPA & NCR management

Build automated response workflows for any quality event. 

Don't just take our word for it!

Hear from our many happy customers

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"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
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"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
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“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
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"I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by January. And we had our ISO 13485 certification by July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
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"We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.

The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it"."
Stephana P.
VP of Quality, Alphazyme
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"There are other eQMS providers that are very well-established, but not particularly accessible to organizations that don't have the fundamental basics in place.

Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind."
Phil C.
Quality Manager, Bond Digital Health
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"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
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"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE. 

Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
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“The cost of our Qualio licences is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
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"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
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"Set-up is easy and very user-friendly.  Qualio gets rid of the paperwork. Simple to use, affordable."
Rachel A.
Medical Outreach Specialist, eHealth Technologies
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“We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.”
Jeffrey B.
CEO, FifthEye
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“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
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"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
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"Any intelligent person would look at Qualio and say, "This is exactly what a cloud-based system should do". But when you actually see it in action, you still think it's pretty cool."
Andrew L.
CEO, ArcScan
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"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
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"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us reduce our workload and our paper trail."
Paul M.
CEO, Arann Healthcare
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"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."
Chris S.
Quality Manager, CureMetrix
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"The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support and chat function."
Soni M.
QA/RA Director, NovoSource
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"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
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"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
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"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
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"Now that we’re electronic, we can grow to 500 or 1,000 employees.
Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel."
Adolfo R.
Director of Information Systems & Data Compliance, IRISYS
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"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
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Qualio enabled us to seamlessly work through our ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.
David H.
CEO, Surfatek
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Initially, we didn't have anyone on the quality side.

The support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch.

It was so streamlined, it was so efficient, they were super helpful and communicative.

That's exactly what we needed - and that's why we went with Qualio.
Heather U.
CEO, EvoEndo
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"Qualio shows we're taking quality seriously and investing in quality improvement initiatives.

We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers."
Edgar G.
Quality Assurance Specialist, The Dot
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