The GxP challenge

Good Practice means having robust systems, processes fit for purpose and reducing product variation.

To do this, you need tools which provide visibility, control and accountability.

Our software is used by global life science, food and beverage and other heavily regulated businesses to implement best practice management systems. Our customers have:

  • Control and confidence in their approach
  • Improved collaboration from shop floor to top floor
  • Validated configurations of our software to meet the most challenging regulations

 

GRC software governance risk and compliance
Complex circle

Our software helps with the 5 P's of GxP

Manage your people

Use Training Records Manager to ensure your people have clear roles and responsibilities, follow procedures and are fully trained.

Procedures

Use Document Manager to document and record processes, ensure deviations are investigated and reported.

Products

Ensure specifications for raw materials, components, intermediate and finished product are managed using Supplier Manager.

Premises

Validate and calibrate equipment performance, have procedures, schedules and records of all premise management in a single location.

Processes

Any required changes follow the change control procedures using Change Manager.

Prior to using Qualsys's software, managing documents and training records was very difficult. Now, all the information is securely managed in one central location, and we've replaced our legacy system which was controlled in SharePoint. The implementation process has been excellent, and I’d definitely recommend this to other organisations who are putting similar systems in place.

Marisa Gonzalez, Group Quality Manager at Biocair

All modules work on their own or together

Our software and services ensure your GxP standards are met.
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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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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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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Mobile document navigator application
Mobile document navigator application
Your employees want to use the right information, not fight with duplicate forms, outdated spreadsheets and cluttered inboxes. Our document navigation application shows the right information to the right person, wherever they are.
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See a live GxP quality management system in action

  • See a live system A member of the Qualsys management team will provide you with a 30 minute live online tour of our software
  • Get your questions answered Not sure about validation? Or perhaps unclear which combination of modules can be used? Our team will help.
  • Ideas and inspiration See how companies like you have previously implemented GxP systems
  • Pricing information When we know a bit more about what you are looking for, we'll provide you with a complete cost of implementation
  • Get buy-in We can help you build your business case, scope the project and put together a best practice Validation Master Plan

Request a 30 minute demonstration of our software

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Global pharmaceutical businesses, NHS trusts and other life-science businesses have been able to validate our software as compliant with the requirements of regulations such as GAMP 5, ISO 9001, ICH GCP E6 and FDA 21CFR Part 11, and electronic signature legislation such as the EU Electronic Signatur...
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