- open source solution
- target area: industrial research, development, production
- max number of documents or versions: just limited by the memory volume, designed for millions of docs
- typical number of users: 100, but theoretically unlimited (some GUI elements will be improved for larger numbers in the future)
- area of usage: cooperation, workflow, regulated doc archiving, need for released documents
- special scope: regulated (medical) industries under e.g. ISO13485, FDA 21 CFR 820 (more keywords: GMP, store records and SOPs)
- ready for software validation (follows GAMP5, not included in the documentation)
- integrated workflow (focus on review, release process; four-eyes principle configurable)
- electronic signature support, if configured: password validation required in the approval process
- each document has an unique, configurable document ID
- tamper-proof document archive
- optional automatic conversion from word to PDF, including document-ID, title and approval data injection
- separate working areas for released and unreleased documents, no hassle with retrieving unreleased docs
- possible to integrate with other systems
- time of system implementation: install 2h; configuration: 10 minutes
- mobile support
- work offline: NO
- multi language support: currently NO, TODO
Our USP - Difference to other DMS systems:
- designed tp support document control in a (medical) regulated environment (keywords: QMS, ISO13485, FDA 21 CFR 820)
- documents are organized in a flexible folder system, so people find documents in an intuitive way
- folder system: one document object can be stored (linked) to multiple folders (intuitive, better than document tagging)
- strict separation of the working area of released documents and documents under construction (needed for regulated environment)