Back to compliance software

Objective

Control, support and integrate all processes required for GxP compliance of automated systems, incl. laboratory equipment, production equipment, information systems and IT infrastructure.

Main functionality

Products are available per automated system compliance process, which has the following advantages:

  • Automated system compliance processes can be integrated to improve efficiency;
  • Integration and automation of the various processes enables paperless compliance;
  • The system can be integrated with any existing system within the company that is involved in automated system compliance;
  • The various products allow for a phased roll-out of the system.

Each product can be configured according to the company’s compliance approach and needs.

The following overview highlights the different high level compliance processes in which the individual products are positioned. Click on the image below for a complete overview of the products suite and the functionality of the various products.

Overview RC-ACMS

Advantages

  • Inspection readiness;
    • in control of systems through an up-to-date overview on the company's systems, their configuration, their compliance state and (progress of) compliance processes
    • automated scheduling and triggering compliance activities
    • documentation in line with changing system through integrated configuration management and Change Control
    • traceability through automated linking of activities, deliverables and content
    • consistent and adequate execution of compliance processes through standardization of approach, documentation and content
    • centrally and readily retrievable documentation
    • management reporting
  • Efficient compliance processes;
    • automated workflow for review and approval
    • integration of compliance processes
    • re-use of deliverables and content
    • risk-based approach and decision mechanism
    • central point for storing and sharing compliance documentation and knowledge
  • Paperless compliance
  • 21 CFR part 11 and Eudralex Annex 11 ready


    The estimated achievable reductions that the RC-ACMS Product Suite allows for can be found here.
    The full product brochure can be downloaded here.
    The full diagram of RC-ACMS can be downloaded here.