Thank you for taking interest in Aligned Elements. You will be up and running in a short moment.
There are several ways to insert data into Aligned Elements. The primary way is to use the Document Object forms for manual data entry. DHF data can also be imported from Word, Excel (via csv) and xml (by applying an appropriate XSLT conversion), generated from our regulatory wizards, downloaded and imported from our preconfigured packages on our website, or copied from your existing Aligned Elements projects.
The primary way of exporting data is to use the Word integration. This mechanism automatically generates Word documents from your DHF data while applying your company Word templates keeping your current look-and-feel intact. Aligned Elements also support a powerful xml/xslt driven export function that outputs all DHF including rich content, traces, etc. You will never be locked-in using Aligned Elements.
Yes, most definitely. Initially, Aligned Elements integrated quality checks will probably generate a slightly overwhelming number of correction points. However, once you have learned what they mean, you will find them indispensable for providing high-quality, consistent DHF data.
We know from experience that the maintenance of DHF's is a painstaking undertaking that very few people enthusiastically embrace. Therefore, we try to automate and facilitate the day-to-day DHF Management operations wherever we can, not by cramming in as much new functionality as possible but by selectively offering smart features in the context where it makes the most sense.
Consistency and Control
We want our customers to have full insight into their DHF status at all times and have full confidence in their product documentation. There should be no unpleasant surprises when the auditor arrives or when the 510k is submitted. We are always looking for new ways to quickly and accurately communicate the current consistency state of your DHF's.
A DHF never exists in regulatory isolation and it, therefore, makes sense to include regulatory knowledge and functionality in Aligned Elements.
Integration and Interfaces to external systems
We acknowledge that the benefits derived from Aligned Elements are dependent on its environment and that integration and interfaces with external systems is a natural extension of the product's domain. Aligned Elements' interface- and integration possibilities to external systems will continuously be evaluated and expanded.
Performance and Scalability
We are carefully observing our performance and scalability to make sure that it is not compromised by added functionality. We do extensive testing and keep in close contact with all our users to continuously locate bottlenecks and improve performance and scalability where it is most needed.