Good Manufacturing 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
FDA CFR 21 part 11 and EU annex 11 compliant electronic signatures provide you with peace of mind & defensible records.
Identify competency gaps and opportunities of your stakeholders, document training records and holistically improve business performance.
Use parallel or sequential workflows to keep your stakeholders informed and drive action where necessary. Eliminate bottlenecks and focus on improvement.
Complete control over SOPs, policies and any other type of document.
Audit trail for everything
There is an audit trail for everything in EQMS. See who changed what, when, why, where and how.
Identify, assess and treat risk as your business adapts, evolves and iterates products and services.
An interactive business intelligence dashboard enables you to track and measure a balanced scorecard of metrics.
Apply your quality methodology
From 5 Whys to 8D, apply your quality methodologies to the workflows in EQMS to embed continuous improvement.
Streamline the planning, management and reporting of audits and inspections.
We don’t simply provide you with our software and say “off you go!”. Qualsys provide support services at every stage in your journey:
- URS templates
- Validation test scripts
- Scoping workshops
- Product training
- Ongoing support
- System health checks
- Audit, SOP, issue & workflow templates and example
- War room audits
- Optional quarterly configuration reviews
Tailored GAMP 5 validation
You will have a dedicated computer systems validation expert who will guide you through each step of implementing and maintaining your eQMS.
Our team have validated more than 500 systems using both IQ/ OQ/ PQ and GAMP 5 methodologies and helped hundreds of organisations to pass regulatory and ISO audits in complete confidence.
Flexible API / ERP integration
Connect your existing tools and systems with EQMS to avoid manual data input issues and drive automatic activity.
Flexible API / ERP integrations can be as simple or complex as your requirements. Qualsys provides a complete service to ensure your integrations align with your data integrity and product quality requirements.