From individual documents to our document management system and process-oriented dossier management — our module “d.velop life sciences | technical documents” supports and simplifies the creation and updating of your technical documentation, e.g. in the context of the requirements of the Medical Device Regulation (MDR). Our process-oriented dossier management is versatile, e.g. also for the creation of site master files, tool logbooks, drug master files, QM documentation, project folders, validation documentation and much more.
How do you benefit from the Technical Documentation software?
Here are some features of the Technical Documentation
Regulatory requirements for Technical Documentation
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Get a live insight into the possibilities of implementing a process-oriented dossier management by means of a sample use case in only 45 minutes. Learn how our solution can support and simplify the creation and updating of your technical documentation within the requirements of the Medical Device Regulation (MDR).
33 Good reasons for a cooperation with d.velop LS
You’re not convinced yet? Find out about 33 good reasons speaking for a cooperation with d.velop Life Sciences GmbH. We will show you reasons from the provider’s point of view, from the software point of view and other general reasons that distinguish us.
Frequently asked questions (FAQs) about Technical Documentation
Templates are available for frequently used documentation, e.g. according to Annex II of the MDR 2017/745. On the basis of a structure used by you, you can also amend templates yourself or have them created as part of the introduction of the module.
You can customize chapter structures and dossier templates or create your own.
Using the tasks ‘Placeholders’ and ‘Document creation’ you specify which documents the dossier must contain before it can be released.
Documents from your desktop or from the file directory can be used in the dossier. They are stored in the document management system and used from there in one or more dossiers.
For each dossier, a main person responsible is identified, who also receives the reminders for completion or periodic review. Individual chapters of the structure can be transferred to a person partially responsible for processing.
Documents are added once to the contents list of the dossier and can then be inserted at several positions in the structure. Documents can also be used in several dossiers.
When a dossier is released, the version is ‘frozen’, changes are only possible in a subsequent version. With the overview ‘Version statuses’ you get an overview of the document versions. To adopt new versions, create a new version of the dossier and decide which version of the documents to adopt.
For documents added to the dossier as attachments, the valid release version is always used.
Printing of documents is possible, the function depends on the specifications from the document management system (controlled — not controlled).
Export as ZIP archive or PDF file is possible for the whole dossier or for selected chapters / documents.
For the ZIP file, the protection is preset with a password. Furthermore, you can preset the creation of PDF/A files to prevent printing and copying and enter a watermark for each export.
The actions are recorded in the audit trail of the dossier, including the output as a ZIP or PDF file and the export of individual documents. The audit trail stores the date and time of an activity for the actions listed below. Moreover, the ID of the user triggering the activity is stored in the audit trail entry.
Documents can be inserted into the dossier regardless of the file format (PDF, MS Word, Excel, PowerPoint, PNG, JPG, TIFF, Visio)
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The Technical Documentation is a component of the d.velop life Sciences solution suite. Each product is powerful on its own, but when used together they are even better.
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