Complete confidence in your approach

‘Making do’ with manual, paper-based processes causes endless communication, data integrity issues and quality challenges. 

Qualsys provides a complete package to enable you to plan, manage and demonstrate GxP and compliance to any pharmaceutical regulation.

Have complete confidence you have the frameworks, robust processes and systems in place.

Integrated, modular pharmaceutical quality management software

Every pharmaceutical business needs a strategy to manage data integrity, to share controlled documentation, treat risks, investigate root causes and demonstrate staff competence.

Qualsys provides a complete and flexible off-the-shelf pharmaceutical quality management software tool. EQMS by Qualsys has everything you need to demonstrate that your products and processes are safe and fit for purpose.

Compliance as a Service

The perceived burden of computer system validation is still the greatest barrier preventing pharmaceutical companies from adopting new technologies.

With Qualsys, there is no reason that should be the case. Qualsys has a dedicated GAMP 5 computer systems validation team who provide a fully managed, flexible validation support package from start to finish.

Qualsys provide support throughout the project lifecycle, from concept requirement gathering to implementation and change management after the product has been released.

QMS software validation Module Implementation & Validation Swimlane
Complex circle

Pharmaceutical compliance

A culture of compliance

Proven validation

Configurations of our software have been validated for MHRA, FDA and many other Regulations.

Everything you need in one system

With free end users and a fast, controlled tool to manage all business processes, it's never been easier to manage compliance end-to-end.

Faster time-to-market

Our software and services help you demonstrate compliance to global regulations, making it easier to get your products approved.

Stronger decision making

Manage complex, cross-functional processes across a global team using controlled workflows and audit trails.

More confident employees

Employees know the information they are using is correct, know the processes are approved and know who to ask if they are unsure.

Proactive culture

Systematically identify risks, vulnerabilities, opportunities and threats using more data from across your business.

Pharmaceutical brands of all sizes rely on our quality and compliance management software and expertise

81% of Qualsys customers said their culture improved after implementing EQMS
Indivior medical device compliance
Biotech quality management software
York instruments medical devices quality management software solution
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Managing actions through to completion

Indivior is a global speciality pharmaceutical enterprise with almost 1,000 employees. In 2016, the company’s revenues exceeded £1 billion. Indivior researches and gets pharmaceutical products to market which help patients with diseases of addiction.

Modules for a pharmaceutical governance, risk and compliance management system

Integrated modules work well on their own or together.
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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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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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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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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Quality and compliance management systems built for pharmaceutical businesses

An easy, straight forward validation process

Qualsys provides a GAMP 5 category 4 ‘configured’ software solution. Each of the modules requires parameters to be set to match your business processes before use. Qualsys’s services team guides you through this process to ensure:

  • Compliance: Trust in our knowledge and expertise. We guide you throughout the validation process to ensure your system is properly validated and documented.
  • Reduce risk: Our software and validation services has been designed for the life sciences industry by experts experienced with GxP regulatory requirements.
  • Long term success: Based on decades of experience, Qualsys has designed a  suite of applications that are easy to validate and stay up to date.
  • Control validation costs: We provide a sustainable approach to reduce your long term validation costs.

More on our validation services 

Validation process at Qualsys

GAMP 5 experts

For many of our customers, having a validation process which verifies that the system is compliant and fit for purpose is critical. Configurations of our software have been validated to meet ISO 13485:2016, GAMP 5, ICH GCP E6, FDA 21 CFR Part 11, Eudralex Volume 4 Annex 11, and the EU Electronic signatures directive.

More on our governance, risk and compliance implementation services here

GAMP 5 certified employees

FDA and MHRA quick-start

Our team have collectively helped our customers sail through over 450 pharmaceutical-related regulatory audits.

Here’s how we help our customers  

Medical laboratory quality and compliance management

Our approach

Our software and services are built around the philosophy that governance, risk and compliance is the responsibility of everyone in the business. This is why we offer free end users, unlimited supplier portals and ongoing training and workshops.

Read about our approach

Compliance software and services

See a live pharmaceutical quality management software system in action

  • Get your questions answered A live online screen share for 30 minutes with one of our management team
  • Understand our validation services A member of our management team will talk you through our validation and implementation services
  • Pricing information We'll show you our pricing structure and give you an all inclusive cost for the software
  • Scoping and discovery Our management team will help you scope the project and work with your validation master plan
  • Case studies We're fortunate enough to work with some of the world's best pharmaceutical companies so can share our successes

Arrange a call back and demonstration today

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5 FDA & MHRA changes to know about in 2019
Every drug, device and clinical company wants to be able to predict how regulations and laws are going to impact their current and future processes. Last month, during our GxP Product Advisory Group event, we invited Sion Wyn, who assisted the FDA as a consultant with its re-examination of 21 CFR P...
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