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Objective

  • Maintain a registration of automated systems (equipment, information systems, utilities, etc.), their status and their configuration
  • Control, schedule and trigger maintenance, calibration, management and use of automated systems
  • Register incidents, maintenance, calibration, management and use of automated systems in a GxP compliant electronic logbook

Main functionality

  • Register automated systems, incl. use and compliance status
  • Configurable system overviews
  • Register system components, incl. hardware, software, equipment, documentation and users
  • Baseline reporting
  • Supplier management
  • Scheduling of activities
  • Automated generation and assignment of tasks
  • Notifications and alerts (incl. escalation) by e-mail
  • Monitor the execution of activities
  • Registration of activities in electronic logbook
  • Approval of results
  • Definition of default activity recurrences and frequencies per system type
  • Trend reporting
  • Management Reporting

Advantages

  • GxP compliant system overviews
  • In control through an overview on the company's systems and their compliance status
  • Full traceability of all configuration changes during the total lifecycle of systems
  • Inspection readiness through scheduling and automated generation of tasks (incl. notifications and alerts)
  • Centrally and readily retrievable logbooks
  • Standardization of logbook information
  • Consistency through definition of default activity recurrences and frequencies per system type
  • Paperless compliance
  • 21 CFR part 11 and Eudralex Annex 11 ready

The product flyer can be downloaded here.