Document Control

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.

All fields marked with * are mandatory.
Please read our privacy policy.