aligned elements Description
Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools.
The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities.
Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.
aligned elements Alternatives
Innoslate
SPEC Innovations’ leading model-based systems engineering solution is designed to help your team minimize time-to-market, reduce costs, and mitigate risks, even with the most complex systems. Available as both a cloud-based and on-premise application, it offers an intuitive graphical user interface accessible through any modern web browser.
Innoslate's comprehensive lifecycle capabilities include:
• Requirements Management
• Document Management
• System Modeling
• Discrete Event Simulation
• Monte Carlo Simulation
• DoDAF Models and Views
• Database Management
• Test Management with detailed reports, status updates, results, and more
• Real-Time Collaboration
And much more.
Learn more
Jama Connect
Jama Connect®, a product development platform, uniquely creates Living Requirements™. This digital thread is created through siloed, test, and risk activities to provide end to end compliance, risk mitigation, process improvement, and compliance. Companies creating complex products, systems, and software can now define, align, and execute on what they need. This reduces the time and effort required to prove compliance and saves on rework. You can be sure of success by choosing a solution that is easy-to-use, flexible, and offers support and services that are adoption-oriented.
Learn more
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
Learn more
QVscribe
QRA’s tools streamline engineering artifact generation, evaluation, and prediction, refocusing engineers from tedious work to critical path development.
Our solutions automate the creation of risk-free project artifacts for high-stakes engineering.
Engineers often spend excessive time on the mundane task of refining requirements, with quality metrics varying across industries. QVscribe, QRA's flagship product, streamlines this by automatically consolidating these metrics and applying them to your documentation, identifying risks, errors, and ambiguities. This efficiency allows engineers to focus on more complex challenges.
To further simplify requirement authoring, QRA introduced a pioneering five-point scoring system that instills confidence in engineers. A perfect score confirms accurate structure and phrasing, while lower scores prompt corrective guidance. This feature not only refines current requirements but also reduces common errors and enhances authoring skills over time.
Learn more
Pricing
Pricing Starts At:
€1300 per year
Pricing Information:
See: 'How to buy' on our homepage for the full offer
Free Trial:
Yes
Company Details
Company:
Aligned AG
Year Founded:
2007
Headquarters:
Switzerland
Website:
www.aligned.ch/
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Product Details
Platforms
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Windows
On-Premises
Types of Training
Training Docs
Live Training (Online)
In Person
Training Videos
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aligned elements Features and Options
Application Lifecycle Management Software
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management Software
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
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