The key features of the Desigo CC solution that are designed to support 21 CFR Part 11 compliance include:

  • Management of Electronic Records – Desigo CC software provides long-term management and reporting of key electronic records. These include trend records, alarm records, system activity records, and Assisted Treatment operating procedure records.
  • Audit Trails – The Desigo CC software provides detailed audit trails on data within the Desigo CC database and automatically records critical changes to records in the history database. This makes the Desigo CC database the central place for reviewing all audit trail information.
  • Security – Desigo CC software uses multi-layered, integrated Windows security to ensure that the right people have access to the right information ensuring necessary record access to all key stakeholders.
  • Direct Interface to History Database – Provides a direct, secure, and reliable data exchange interface between the Desigo CC application and the history database. This interface reduces configuration time and provides increased robustness in the transmission of data to the long-term data management solution without having to be logged at an intermediate location.
  • Advanced Electronic Records Processing and Reporting – Desigo CC applications provide a wide range of report and processing tools to turn data into information. These include:
    • Alarm Summary Table with Chart Report – Provides detailed alarm event totaling, average total alarm time in tabular, and graphical summaries
    • Summary Statistics Table with MKT Report – Report designed to show key statistical summaries including MKT
    • Scatter Chart Report – Chart showing the historical value of one or more objects for a selected time range
    • Multiple Point Trend Data Table Report – Tabular report showing values of multiple trended objects compared over a time range
  • Enterprise-Wide Access – Desigo CC is specifically designed such that it can be personalized for users who might not typically use the building automation system. Desigo CC also efficiently distributes information over the existing enterprise network to stakeholders who need it, when they need it.
  • Archive Management – Desigo CC provides long-term data management with ability to create multiple history database volumes that manage online and offline data so that users can simply focus on requesting the data they need, not trying to locate it or reload it. Archiving flexibility ensures that an archiving strategy can be developed to meet a wide range of data management needs.