Back to compliance software

Objective

Store, manage and publish quality documentation (e.g. SOPs, validation documentation, etc.), in accordance with GxP regulations.

Main functionality

  • Uploading of documents with common file types and generation of .pdf versions
  • Storage, review and approval of documentation
  • Publish and search for documentation
  • Configure document (sub)types and corresponding review and approval workflows
  • Configurable roles and rights
  • User interface depending on roles and rights
  • Version Management
  • Schedule and trigger periodic review of documents
  • Possibility to print authentic copies
  • Management Reporting

Advantages

  • GxP compliant document management
  • Standardized and efficient document workflow
  • Centrally and readily retrievable documentation
  • Paperless compliance
  • 21 CFR part 11 and Eudralex Annex 11 ready

The product flyer can be downloaded here.