Real Regulatory eTD Functions
Every feature, every function, every button - Designed for your regulatory process
Shift the focus from documents to high-quality, redundancy-free content. Set a new standard for data integrity and a single source of truth.
Automate your documents with templates to put them on autopilot. Includes automatic redlining for future versions and one-click updates.
Integrated Document Writer
Write intelligent documents connected to your single source of truth. Finally, a document that works for you and lets you know when it is out of date.
Inspect your TechFile content for GAPs and keep track of your projects. e.g: If the product is sterile, the inspector will tell you what is missing.
Your documents are constantly monitored. As soon as new data becomes available, your documents will turn "red" so you are aware of any updates that need to be made.
Folder & Submission Inspector
Every single TechFile version is monitored and will tell you if outdated documents have been used in the past for registration or audits. Updating your TechFile is now a snap!
Automated Folder Structures
Never create technical documentation by duplicating folders and documents again. Virtual Folders takes over and presents your TD the way you need it.
Data Connection Monitoring
Every bit of data is connected. Have deep data insights in your eTD. Where is this particular indication used in the portfolio? You know in seconds.
Write down your thoughts where they belong. To a specific content in your eTD. Your colleagues can help you! Communication within your eTD is fun.
No matter if you have 1 product or thousands. Changes are fast and covered by the audit trail.
Dynamic Approval Workflows
Set up dynamic approval workflows for your digital records or documents. Eliminate printing and scanning. In compliance with 21 CFR Part 11
Your data is covered by a full audit trail / version history. In compliance with 21 CFR Part 11
More Collections & Processes
EUDAMED data is eTD data. No need to maintain this type of data in a redundant database. Keep it lean.
Implement standards and guidelines in a best-practice process. Automatically incorporate new data into your technical documentation.
Your ANNEX I will be always up to date. A single source of truth is covering your important evidence document.
Track your contacts & legal entities to use data in your technical documentation. All data and documents in one place.
Your component data appears in multiple areas of your TechFile. Automate this data to keep your records clean.
meddevo eTD is an open platform. You are free to build the structures and processes you need to meet the needs of your company.