The 3-Factor Key: This is how the technical documentation of tomorrow works

The technical documentation is the basis for a successful conformity assessment procedure and thus a decisive factor on the way to approval of the medical device.

When creating the technical documentation, questions often arise in the work process, such as: Which documents (still) need to be incorporated? What is the current status of the documentation process? And who is responsible for what work in the first place?

These three important factors are particularly important: teamwork, digitization and monitoring. Digitally capturing documents together and in parallel in a clearly structured and audit-proof environment – that is the tangible future of technical documentation.

How to – this is how simple documentation according to MDR and IVDR for medical devices is: We would like to give you an insight into our solution.

That‘s what it’s all about:

The BAYOOSOFT Themis Documentation Guide supports you in creating your technical documentation according to Medical Device Regulation 2017/745 (MDR) and prevents redundancies by centralizing your documents. Each document is represented as a task, these are linked to each other, thus ensuring a single source of truth.

The web-based and structured solution guides you through technical documentation in accordance with MDR – from start to submission. After completion, you receive the initial document for the notified body, which bundles all individual documents.

BAYOOSOFT Risk Manager So funktioniert die Technische Dokumentation von Morgen

The teamwork factor:

The preparation of technical documentation is usually the task of several responsible persons. The close and comprehensible cooperation of all those involved is therefore the decisive factor when it comes to the successful submission of the technical documentation to the notified body. So how can team collaboration be supported to the maximum by a software solution? With:

User assignment at task level
Each task is a requirement to be fulfilled, which is assigned to a responsible person. The advantage: You can track at any time, which:r processor:in has completed a change and avoid responsibility diffusions in the project.
Collaboration through comment functions
Queries by mail, phone or chat? This prevents traceability in the project. Instead, set comments in each task to keep an overview even after a few weeks.
Multi-user access
Create synergies in the documentation process. Multi-user access allows several employees to work on a project simultaneously across departments. Overwrite existing work results? The own assignment of the tasks of another editor is only possible after a warning of the system.
Progress bar
What is the progress of the project? A progress bar shows you the current status of each task broken down in a pie chart.

The factors of digitization and monitoring:

Working with numerous Word and Excel documents is also a form of digitization, but it is not effective. Because employees quickly lose track of things here. With a web-based solution, you can instead focus on teamwork and compliance with current standards. How can digitization support your project? With:

Status indicators
A live update about your project? No problem. Use the indicators to always keep an eye on the processing status of the technical documentation. This function is not only a monitoring element, but also an important intermediate step in the release cycle of the individual elements.
Document management at task level
A specific document upload is available for each proof of technical documentation required by the authorities. This way you avoid keeping different documents and versions and ensure that your complete documentation is in one place.
Audit Trail
Don’t miss any changes to technical documentation. The audit trail automatically captures and stores every change throughout the system. This helps you avoid information loss and undocumented modifications.
Task-based report outputs
You can create individual reports for each task and thus each MDR requirement. This is automatically marked and transferred to your documents without causing any loss of information.

You also see the 3 factors as the key to the successful creation of technical documentation?

Then get to know BAYOOSOFT Themis and the Documentation Guide as a free trial version. We would also be happy to inform you about our solution during a personal product presentation or one of our webinars.

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The 3-Factor Key: This is how the technical documentation of tomorrow works

The teamwork factor:

The factors of digitization and monitoring:

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