Document Management System (RC-DMS); Store, manage and publish quality documentation (e.g. SOPs, validation documentation, etc.), in accordance with GxP regulations.

Exception Handling and CAPA (RC-CAPA); Manage and support:

  • handling of exceptions, incl. deviations, complaints, audit findings, etc.
  • registration and monitoring of corrective and preventive actions

in accordance with GxP regulations.

Training Management System (RC-Training); Control, support and register training in accordance with GxP regulations.

Change Management System (RC-Change); Control and support the change control process, in accordance with GxP regulations.

System Management and Electronic Logbook (RC-Logbook); Management of automated systems and registration in a GxP compliant electronic logbook.

Validation, Qualification and Commissioning (RC-SDLC); Manage and support development, engineering, implementation, validation, qualification and commissioning of automated systems to ensure compliance with GxP regulations and company procedures.

Automation Compliance Management Suite (RC-ACMS); Control, support and integrate all processes required for GxP compliance of automated systems, incl. laboratory equipment, production equipment, information systems and IT infrastructure.