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Streamline Compliance with Aligned Elements – Advanced Requirements Management Software
Aligned Elements is an innovative requirements management tool designed to simplify the design and development processes for businesses operating in regulated industries....
Streamline Compliance with Aligned Elements – Advanced Requirements Management Software
Aligned Elements is an innovative requirements management tool designed to simplify the design and development processes for businesses operating in regulated industries. Particularly suited for medical devices, the software enables users to efficiently create, manage, and trace design control documentation such as the Design History File (DHF). Founded by experienced professionals in the life sciences sector, Aligned Elements combines risk management and requirements traceability in a single, customizable platform.
Why Use Aligned Elements?
Aligned Elements shines in the competitive requirements management space by offering the following key benefits:
- Streamlined Requirements Management: The software helps organize and trace all design elements from user needs to final verification, ensuring comprehensive coverage for compliance and audits.
- Effortless Risk Management: Integrated risk management tools allow for seamless linking of risk assessments to related design artifacts, improving traceability and efficiency during development and beyond.
- Customizability: Users can adapt templates, processes, and documentation structures to meet specific business or regulatory needs, enhancing usability and alignment with internal workflows.
- Document Control and Automation: Features like change tracking, automated consistency checks, and tailored document generation ensure meticulous control over design deliverables while saving time.
- Flexible Collaboration: Built-in collaboration tools help teams work together within the platform, enhancing efficiency and communication for tasks such as review cycles and prioritization.
- Enhanced Audit Readiness: By consolidating all documentation in one platform, Aligned Elements ensures audit preparedness with minimal manual effort.
Who is Aligned Elements For?
Aligned Elements is ideal for:
- Medical Device Developers: Companies subject to FDA and EU MDR/IVDR regulations benefit from tools designed to manage design control documentation efficiently.
- Regulated Industries: Organizations with compliance-driven requirements can leverage the platform for consistent and reliable traceability and documentation.
- Mid-Sized Teams and Enterprises: Teams working on complex designs value the scalability and adaptability of Aligned Elements for their evolving needs.
- Quality and Risk Managers: Professionals responsible for maintaining regulatory compliance and managing lifecycle risks will find significant value in its built-in risk analysis modules.
In conclusion, Aligned Elements is a versatile and robust tool that simplifies compliance and enhances traceability for businesses in regulated environments. By integrating requirements, risks, and collaboration into one platform, it delivers efficiency and ensures alignment between design processes and regulatory expectations. Whether developing complex medical devices or managing compliance-heavy projects, Aligned Elements serves as a dependable solution.
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Steps to Cancel aligned elements Subscription
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To cancel an Aligned Elements product, follow these steps:
- Contact the Aligned Elements support team through their support request form.
- Provide details of your subscription or license.
- Follow the instructions given by the support team to complete the cancellation process.
- Ensure any necessary changes to your system settings or integrations are made as advised.
For more specific guidance, refer to the Aligned Elements support center.
Most frequent question about aligned elements
Aligned Elements is a Medical Device Application Lifecycle Management (ALM) system designed to help medical device manufacturers and suppliers create, manage, and maintain their medical device development documentation, ensuring compliance with highly regulated markets.
Aligned Elements offers features such as Design Input and Output management, Risk Management, Verification and Validation Management, document management with version control, issue management, and traceability of Design Control Items. It also includes automatic consistency monitoring and real-time assessments to uncover any faults or gaps in the documentation.
Aligned Elements keeps all document changes under strict version control. Each committed change to a document object creates a new revision, and old revisions cannot be altered. This system provides a complete and chronological audit trail of all changes.
Yes, Aligned Elements can be configured to each customer’s unique QMS, development process, and document templates. It allows for the modification of existing document object templates or the creation of new ones to accommodate local quality and development processes.
Aligned Elements can be deployed on-premise, in the cloud, or as a hosted SaaS solution, offering flexibility to fit different company needs.
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