Robust quality management systems

You need to produce products that are safe and fit for purpose. To do this, you need employees who know what is expected of them, processes that work, and evidence that the processes have been implemented.

Our software is designed to give you complete control and visibility over all of your business processes.

KPI integrations GRC software quality management
Getting new Magnetoencephalography products to market

York Instruments uses our electronic quality management system to plan, communicate, record and validate their processes.

Modules for medical device quality management systems

Equipment maintenance software
Equipment maintenance software
Over 70% of organisations have no formal method for managing how equipment is used, maintained and eventually replaced, or for ensuring there’s a qualified person on-site to operate that equipment. Managing business equipment correctly is crucial if your organisation is to compete in the fast-pace...
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Audit management software
Audit management software
Too many businesses hope that when an external auditor is examining their business they don’t uncover any issues. But this approach causes stress, encourages a reactive culture and exposes the business to high levels of risk. A regular and thorough internal auditing programme helps you identify an...
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Accident & incident management software
Accident & incident management software
When an accident or incident occurs, it's important there is an accurate record of events to understand the root cause and prevent it from happening again. Use our accident and incident management software to properly record, communicate and identify trends to prevent it from happening again.
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Document control software
Document control software
Modern technology means we are bombarded with information. The challenge is making sure the right information is viewed by the right person at the right time. Document Manager by Qualsys provides a comprehensive and powerful solution for the distribution and control of all types of crucial documenta...
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Supplier management software
Supplier management software
Qualsys's supplier compliance management software provides you with all the controls you need to treat external providers as an extension of your business. Deliver unshakeable governance, risk and compliance controls, understand supply chain risks, and extend quality best practice to your suppliers....
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Read our validation brochure

Learn about our five-phased approach to managing computer systems validation, and how we help you to comply with regulations and Standards such as ISO 13485:2016, GAMP 5, ICH GCP E6, FDA 21 CFR Part 11, and the EU Electronic signatures directive.

Life science and medical device case study booklet

Don’t just take our word for it. See all the great things our customers have achieved using our software.

Want to learn more about using our medical device quality management software? Schedule a 15-minute discovery call

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ISO 13485 software validation process
When you're implementing an electronic medical device quality management system, your software validation plan is of the utmost importance. You'll need to ensure that your system is working and continues to work as required.
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