Document Management System
In many industries, strict controlled management of documents is necessary. If your organization needs to comply with certain regulations (such as ISO standards, FDA CFR 21 Part 11, etc.), this will sound familiar. We have experience in setting up Document Management Systems (DMS) where various types of documents must follow specific predefined review and approval processes.
Traceability
It's important to be able to trace every step in the drafting and approval process to determine when and by whom a specific action was taken: who created or edited a document (in minute detail), who conducted a review and what was the outcome, who approved it on which date and time, etc.? This history must be accessible at all times, including for previous versions of documents.
Access rights
Within a controlled DMS, it's important that not every user can simply modify documents. Access rights are automatically assigned based on the status of documents and the role of a user. Moreover, these rights can also depend on the user's department, categorization of the document, the type of document, or other properties.
Other solutions
Questions about Controlled DMS?
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