When it is time to compile your Technical File, with us, the document creation will be a swift affair. With all Design Controls already in place, you can quickly insert them into your released and ready document templates with a single operation.

Our built-in Document Management system ensures that each document is easily located and only accessible to those with appropriate permissions. 

• Consistent revision mechanisms ensure full accountability of every document change

• Complete history of all previous document revisions ensures full traceability for audits and regulatory inspections

• Intelligent consistency checks warn you if the document contains outdated Design Controls, with a one-click synch option 

You focus on building safe, effective devices. Aligned Elements is there to assist you with the documentation details.

With Aligned Elements, routing documents and sending out sign tasks happens automatically.

• Speed up approvals by assigning signature responsibilities to roles, allowing the first available person to sign - no more waiting on specific individuals, using sequential or parallel sign-off workflows

• Never miss a step with automatic email notifications and personalized dashboards that keep you instantly informed when it is your turn to sign.

• Ensure FDA 21 CFR Part 11 and Annex 11 compliance with FDA-recommended x.509 V3 Class I certified digital signatures that provide legally binding, tamper-proof approvals.

Released documents are displayed in a dedicated view to clearly separate them from documents in draft or review mode.

This means your team can finalize DHF documents electronically, streamlining your Technical File effort, all within Aligned Elements.

MS Word: Use a software you already know to create your Technical File documents. Ensure that the document style matches your corporate identity.

Aligned Elements supports the controlled creation of Technical File / DHF documents using a direct insertion of design control elements into documents using our unique Word Add-In.

Automatically generate traceability matrices, risk summaries, checklists, and DHF indexes. All Design Controls, requirements, specifications, risks, and tests and more, can be placed into any number of documents. 

The Aligned Elements Word integration supports one-click bi-directional synchronization between document and database.

The documents are updated with changes from the database. The database is updated with changes in the documents.

Automatic detection of an out-of-sync state between document and database is highlighted to the user. Synching the document will automatically update the document's version history. 

Managing the multitude of documents that form your Design History File (DHF) is easier and more reliable when you track them using a dedicated STED / DHF Index.

This is where you specify the required documents in your Technical File, what templates to use, and who shall sign off on each document.

Aligned Elements offers a built-in DHF Index that automatically keeps track of every document’s status, updating in real time as changes occur.

Plus, powerful consistency checks give you clear, visual insights into the current completeness and health of your DHF, helping you identify gaps and stay on top of your documentation effortlessly.