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Aligned Elements - Design History File Traceability Made Easy
Aligned Elements is built to compile and manage your DHF (Design History File) documentation by efficiently controlling a large number of individual but related Design Control items.
Requirements, Specifications, Tests, Risks, Reviews and Defects are all managed, traced and controlled in an efficient and transparent manner.
Aligned Elements empowers you to keep your Design History File complete and consistent during the entire project development process with minimal effort.
Aligned Elements has been specifically developed with the particular regulatory requirements of the Medical Device Market in mind.
Aligned Elements...
- Is Easy To Set Up and To Use
- Captures And Traces all DHF Items
- Records a full Change History
- Integrates with Microsoft Word
- Includes Tools for Risk Analysis
- Enables Integrated Design Reviews
- Clearly Displays Inconsistencies
- Built for FDA 21 CFR Part 11
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Screens
- - Capture Requirements
- - Work with your FMEA
- - Consistency Evaluation
- - Gap Evaluation
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5 ways to speed up your work
Find out how Aligned Elements is built to simplify your daily work. Easy-to-use functions that provides maximum control with minimal effort.
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Covering Regulations
Find out how Aligned Elements specifically meet the FDA QSR requirements on the content and handling of Design History Files.