###### AUDIT MANAGEMENT

# Always audit-ready, not just audit-prepped

#### Make stressful, last-minute audit prep a thing of the past. Continuous readiness across every framework, with evidence collected automatically.

## Audit management software for smarter, calmer audits

#### 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.

#### Solution

Qualio gives your team the audit management tool you need for maximum, constant audit readiness.

Access data, prove compliance, demonstrate improvement and respond to 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 audit management system
- 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 QMS audit schedules and tasks

### Save time with automated document and data processes

- Ditch the challenges of paper-based audits with cloud-based quality audit software 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

### Make audit readiness your competitive advantage

- Squash the risk of fines, penalties and product recalls by connecting your audit management program, data and teams to a centralized audit management software platform
- Easily assign QMS audit tasks, manage due dates and track findings to completion - all from a single audit management solution
- Enjoy end-to-end traceability for all CAPAs, non-conformances, and other quality events to demonstrate complete control and visibility to your auditors

## Quality management audit resources

#### Audit readiness checklist

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

[Get my checklist](/content/resources/audit-readiness-checklist/index.html)

#### Passing an audit webinar

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

[Watch webinar recording](/content/resources/webinar-preparing-for-and-passing-audit-expert-panel/index.html)

## See other features that make Qualio the \#1 top-rated audit compliance software

#### Supplier management

Control and categorize suppliers and third parties with complete visibility.

[Learn more](/content/product/supplier-management-software/index.html)

#### Document management

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

[Learn more](/content/product/document-management-software/index.html)

#### Design control management

Supercharge your product development from a single source of truth.

[Learn more](/content/product/design-controls-software/index.html)

#### Risk management

Detect and mitigate risks and comply with

ISO 14971 and ICH Q9.

[Learn more](/content/product/risk-management-software/index.html)

#### Training management

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

[Learn more](/content/product/training-management-software/index.html)

#### Change control management

Manage change activity easily and effectively with complete traceability.

[Learn more](/content/product/change-control-software/index.html)

#### CAPA & NCR management

Build automated response workflows for any quality event.

[Learn more](/content/product/capa-management-software/index.html)

#### Compliance management

Get audit-ready in weeks, stay audit-ready forever.

[Learn more](/content/compliance-management-software/index.html)

## Trusted by 500+ life sciences companies

### Hear from our customers

##### “We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing quality to one department, Qualio breaks down that barrier.”

###### Daniel A.
###### Chief Technology Officer, InVivo Bionics

##### "When you're using paper, you're not moving forward. You can't.

##### Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now.

##### I don't think that'd be possible if we didn't have Qualio."

###### Ami A.
###### Director of Ops & Quality Management, NeuFit

##### "I’ve never been more confident in my 27 years of being audited."

###### Lowell H.
###### Director of Quality Assurance, Restech

##### "Qualio is the best QMS cloud-based system I have ever seen."

###### Paul H.
###### Senior VP of Ops, Tech & Quality, Advantice Health

##### "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

##### "We were able to complete a demanding audit thanks to Qualio. The smart links made navigating between processes seamless and easy to understand."

###### Thais S.
###### Head of Quality & Regulatory Affairs, Cergenx

##### “Qualio has helped make my life as a quality manager very easy.”

###### Gene V.
###### Quality Manager, Cirris

##### "We looked a lot at how Qualio worked, its user interface, and the technology behind it. It was by far the freshest, most logical eQMS system out there."

###### Dmitry F.
###### Chief Technology Officer, ViQi

##### "I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July.    Without Qualio, we'd never have done that."

###### Karen H.
###### Head of Quality & GxP Compliance, 30 Technology

##### "Qualio’s become a verb here. When people need things, Qualio is the word that’s used."

###### Chris R.
###### QA Associate, AGADA Biosciences

##### "There are other eQMS providers that are very well-established, but not particularly accessible.    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

##### "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

##### "Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of an 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

##### “The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”

###### Peter B.
###### Director of QA, Watchmaker Genomics

##### "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

##### "I entered a world with Qualio where quality is no longer a hassle."

###### Fedora B.
###### Co-Head of Biopharma Corporate Finance, JMP Securities

##### “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

##### “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

##### "Qualio keeps us in a constant state of audit readiness."

###### Deb G.
###### Director of Quality, Dimension Therapeutics

##### "Qualio is far superior to other systems I've worked with in the past.

##### The flexibility has been mind-boggling."

###### Michael H.
###### QA Director, TriMed

##### "A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."

###### Gareth Q.
###### Director of Quality, iMIX

##### "Document control took anywhere from 5 hours to 3 days. Now things get done in hours, even minutes. I can send training out in seconds now. Qualio has made my life 100% better!"

###### Angela P.
###### QA Manager, Akadeum Life Sciences

##### "Qualio helps me sleep better at night.

##### Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant."

###### Heather U.
###### CEO, EvoEndo

##### "We passed our MDSAP recertification audit with Qualio!"

###### John P.
###### Quality Assurance Manager, KUBTEC Medical Imaging

##### "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

##### "I feel 100% ready in our 510(k) and ISO 13485 preparations.

##### Qualio let us bring quality in-house in a way that will make us successful."

###### Hilary B.
###### VP of Regulatory & Quality, SimBioSys

##### "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