We are finally here! After 18 months of hard work, we are ready for the imminent launch of the Aligned eQMS, our new electronic Quality Management System that perfectly complements our tried and tested Aligned Elements Design Control ALM.
Built specifically for Quality and Regulatory professionals in the medical device and IVD industries, Aligned eQMS provides a complete, ready-to-use, and compliant quality management system allowing you to focus on developing safe, innovative products instead of reinventing QMS processes from scratch.
A Proven, Off-the-Shelf QMS Package
Aligned eQMS comes preloaded with 31 Standard Operating Procedures (SOPs) and more than 100 templates, offering a complete, field-tested framework for compliance with EU MDR and IVDR and FDA QSR.
The SOPs and templates have been written and audited by our colleagues at Quaregia, a well established team of quality and regulatory professionals who have synthesized more than 35 years of collective experience and best practices into this high-quality content.
By combining this QMS content with the Aligned platform, we have created an eQMS supercharge with automated change control, audit trails, traceability, automated consistency checks and branded reporting ready for you to use.
This means your Quality and Regulatory team can work in the same efficient manner to solve their daily compliance tasks as your engineering team solves Technical File actions in Aligned Elements.
Digitally Manage your QMS
With Aligned eQMS, you can manage a wide range of quality processes in one secure, intuitive, and fully digital environment:
- Document Management: Control, approve, and archive your QMS documentation efficiently.
- Training Management: Assign, track, and verify employee training and competency.
- Quality Event Management: Capture and manage Feedback, Nonconformities, CAPA and Vigilance Reports with full traceability.
- Supplier Management: Select and approve, register and monitor your suppliers digitally.
- Change Management: Request, plan, implement and track changes in a structured manner with full linkage.
- Computer System Validation (CSV) Management: Maintain compliance for your software tools with ready-to-use templates and records.
- Equipment Management: Track calibration, maintenance, and qualification of equipment.
- Audit Management: Plan, execute, and document audits seamlessly within your QMS.
A Natural Extension of Aligned Elements
Aligned eQMS is designed to integrate with Aligned Elements Design Control functionality, providing a unified platform for both product development and quality management. This alignment ensures full traceability from design input to post-market activities, being a cornerstone of compliance and efficiency.
Ready When You Are
Whether you’re a start-up establishing your first QMS or an established manufacturer looking to digitalize and streamline existing processes, Aligned eQMS provides proven, compliant, and maintainable foundation right out of the box.
Stay tuned for the official launch announcement and get ready to experience the next evolution in digital Quality Management.
