MHRA-compliant systems

The Medicines and Healthcare products Regulatory Agency (MHRA) are constantly updating and changing requirements to ensure medical devices and medicines supplied in the UK are safe and fit for purpose.

Your business needs agile processes, complete visibility and a collaborative approach in order to respond rapidly to any changes.

Our software provides you with an integrated management system so that compliance can underpin every decision made, every process is properly recorded and risks are identified before it impacts your product. With free end users and unlimited supplier portals, you can be confident in your approach and demonstrate best practice throughout your business.

Best of all, we provide a complete validation package so you’ll have a validated product from day one and a proven validation methodology which will help ensure your systems and processes move with the times.

KPI integrations GRC software quality management
Complex circle

How our solutions help you comply with the MHRA

All modules work on their own or together.

Audit trails and workflows

Our system records everything so when an auditor or customer visits you can demonstrate just how organised, proactive and diligent your business truly is.


Collect risk data from across your business.

Instant reports

Real time reporting enables your business to act faster and make stronger, collaborative decisions.

Control suppliers

Track supplier performance over time and monitor any changes to products and supplies provided.

Training records

Plan and manage training in a central system. No more messy spreadsheets.


Document important information such as your Trial Master File (TMF). Our software provides a robust framework for good documentation control.

Software for MHRA compliance

All modules work well on their own or together.
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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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, Eudralex Volume 4 Annex 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 results our customers have achieved using our software.

Speak to an expert about using our software for MHRA compliance