Regardless if work/process instructions (SOPs), process descriptions, test and operating instructions or various other document types – you can create, revise and sign them electronically with our “Document Control“ module.
Your benefits
- Manage your specifications (e.g. work /process instructions, test specifications, hygiene plans, operating instructions), form sheets, contracts and other document types completely electronically
- Reduce the process runtimes for creation, revision, release and distribution of your specifications
- Signature workflow and distribution of documents are done with a click
- Reduce unnecessary printouts and paper on your desk. This protects the environment and saves your nerves
Details
- Management of specifications and form sheets
- The creation of regulated/controlled documents is done on the basis of released templates in the system.
- The templates may also be controlled documents.
- You sign documents electronically with our integrated GxP compliant signature solution – purely software-based
- Periodic review
- Individual and dynamic forced watermark
- Controlled and logged printing
- Easy creation of report lists
- Windows and Web-Frontend
- Full-text search based on document content and document attributes (meta data)
- Integrated archiving on the basis of d.3ecm system
Regulatory requirements
- ISO 9001:2015, chapter 7.5
- ISO 9001:2015, chapter 4
- FDA 21 CFR Part 11
- EU-GMP guideline, annex 11
- WHO: “Guidance Document on Good Data and Record Management Practices”
- EFG-Votum V11002: Requirements regarding the electronic data storage
- EFG-Votum V11003: Requirements regarding electronic signatures and initials
Quick contact
Do you have a question on our solution? Do you want to be connected with an experienced contact partner from the department?
Our sales team will help you quickly and easily.