User and administator training
Ennov offers a set of training videos to its eCTD247 customers. Once you have created your account, you will be granted access to all the training videos. The following process shows the proposed order for following these tutorials:
A – Learn how to manage your regulatory documents.
- Log on to the system and discover the interface.
- Easily create your documents from templates. Use metadata to organize your documents. Documents can be created in the system by any department of the company (quality, R&D, Production..), not just regulatory affair experts.
- Ensure that your documents follow your predefined authoring, approval and release process.
- Quickly and securely share your documents, instead of sending documents by email.
- Manage document versions.
- Easily find your documents thanks to a google like search engine.
B – Learn how to create and publish your eCTD submission.
- Create a new eCTD submission and edit the dossier. Choose the type of dossier you want to create: eCTD M1 US, CA, EU, CH, GCC, NeeS, vNeeS, or even paper submission.
- Easily access the right version of your documents thanks to eCTD metadata or drag and drop documents from your disk.
- Drag and drop your documents at the right location in your eCTD submission.
- Create hyperlinks at the submission level without modifying the document themselves – optional.
- Create STF (Study Tagging files) – optional.
- Check whether your dossier is valid.
- Publish it!
- Your submission is now ready to be sent to Health Agency.
- Create a new sequence by just revising your submission.
- Create a new submission to another region/country by duplicating an existing one.
Ennov recommends, as a client of the “Essential”, “Premium” or “Enterprise” offers, to participate in training in our office, on-site or remotely.
We propose the following training offers:
- User training – Ennov Document Management (1 Day)
- User training – Ennov eCTD offer – electronic submissions (1 Day)
- User training – Ennov eCTD offer – paper submissions (1 Day)
- Administrator training – Ennov Document Management / Ennov eCTD offer (1 Day)