GxP software

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

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

Training records management software

Plan, test and manage the competency of your team from a single, integrated system.

Risk management software

Use Risk Manager as a framework for making risk-based thinking, quality improvement and right first time part of your business culture. .

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...

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...

Change control software

Promote a right-first-time culture by managing change properly.

Asset management software

Use Asset Manager to reduce waste, prevent costly mistakes and promote a right first-time culture.

Complaints management software

Everything your business needs to proactively manage the complaints process.

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.

CAPA software

Use our CAPA management software module to address any change in the right way.

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...

Policy management software

Use our policy management software solution to stay compliant, reduce waste and create a culture of ownership.

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....

Bespoke modules

Tackle your bespoke business needs with our custom GRC software development services.

Mobile auditing application

Identify risks, vulnerabilities and opportunities anywhere in your business at any time.

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.

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

GMP for new life science and medical device manufacturers training

This stimulating course systematically builds up your knowledge throughout an intensive day. We'll cover regulations and standards for GMP life science and medical device businesses.

Technical philosophy

Trust in our development approach to help you meet even the most demanding regulatory requirements.

Life science

You need to prove your products are safe to use and will deliver the intended results. Our software provides you with a best-practice framework and all the evidence you need to keep control of your processes and demonstrate consistency.

Food and drink

When it comes to sourcing, processing and packaging food, variation is dangerous. Our food safety and compliance management software helps you plan, manage and demonstrate that you've followed the correct processes, policies and procedures.

FDA

Use Qualsys's software to get control, visibility and confidence that your business complies with the FDA (Food and Drug Administration).

Medical device

Protecting your patients and getting your medical devices to market starts with a strong quality and compliance management system. Our software and services guide you through the entire process, ensuring you have a best-practice system which meets the most rigorous compliance requirements.

ISO 13485

With increasing regulatory pressure to implement robust design controls, supplier accountability and risk-based thinking, many companies in the medical device industry opt to follow ISO 13485:2016 for a best practice framework. The Standard harmonises global medical device regulations, helping compa...

Validation

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...

ISO 14971

ISO 14971 defines international requirements for risk management systems for medical devices. Our software helps you to implement best practices throughout the entire lifecycle of your medical device.

How Sodexo uses Qualsys's cleaning audit software for 67% time savings and GxP compliance

As the world's 19th largest employer active in 80 countries, Sodexo chose Qualsys's cleaning audit software module for a simple, scalable pathway to a clean and compliant workplace across 34,000 sites. Here's how Sodexo uses Qualsys' governance, risk and compliance management software application fo...

Good practice (GxP) in the pharmaceutical industry

If your business operates in a heavily regulated industry such as pharmaceuticals, you're likely to know all about the concept of good practice (GxP).

Good Distribution Practice (GDP) – How enlisting a consultant can ensure compliance

EU guidelines revised in 2013 set out best-practice methods for how medicines and other pharmaceutical products should be stored, transported and handled. These Good Distribution Practice (GDP) guidelines have gained real traction, and the regulator, MHRA, is putting more and more pressure on busine...