How Aligned Elements Covers FDA QSR 820

All of us who work at Aligned has experience in the work with DHF's. Our goal is to provide tools and services that generate complete and consistent DHF's through minimal effort.

We are constantly trying to keep our eyes on two things, first how to easily include as much of the DHF content as possible while keeping it consistent and secondly, to minimize the manual work. We have built Aligned Elements to cover the following parts of the Design History File in terms used by FDA QSR 820:

- Intended Use

- Design Input through Requirements Documentation

- Hazard Analysis through Risk/FMEA Analysis

- Design Outputs through Specifications and/or Use Cases

- Verification through planning writing and execution of Test Cases

- Validation through Validation planning and documentation

- Traceability Analysis through setting, analyzing and managing traces

- Revision Level History through tight control of all changes made

- Change Management through Issue Tracking

- Unresolved Abnormalities handling through analysis of inconsistencies

- Design Control via structured Design Reviews