Whether you supply, manufacture or provide services for pharmaceutical products, you need to demonstrate your processes are safe and fit for purpose.
Establishing a formal, structured and unshakeable compliance management system from day-one saves considerable confusion, stress and time.
Qualsys’s pharmaceutical compliance management software and implementation services provides you with:
- A central system for all processes, policies and procedures
- Audit trails, electronic signatures and compliance controls delivered in the background
- Best practice validation support and sustainable re-validation process
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.
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.
Systematically identify risks, vulnerabilities, opportunities and threats using more data from across your business.
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.
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.
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.
FDA and MHRA quick-start
Our team have collectively helped our customers sail through over 450 pharmaceutical-related regulatory audits.
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.
- 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