CompliantPro™ – system overview

Siemens_IBS-QMS_CompliantPro-system-overview

CompliantPro™ comprises a basic system and additional components. The modules are integrated with each other but in some cases can also be implemented either individually or in combination with others. In this way they can be used as a smaller solution to start with and be expanded with further modules at a later date.

The benefits at a glance:

  • CompliantPro™ is a web-based solution, i.e. the end user merely requires Web browser and can work anywhere
  • Integrated user administration enables reliable role and function allocations for each individual user. This ensures access security at the various levels.
  • The system is strongly oriented around Best Practices, as well as regulations and requirements such as ISO 14971 und ISO 13485, OHSAS18001, FDA 21 CFR Part 11 and 820, BS8800 und ANSI/AIHA Z10-2005, ISO 31000, SOx, ISO/IEC 27002:2005 (ISO/IEC 17799:2005), Basel II und AUS/NZS 4360, SOx sections 302, 404, and 409
  • CompliantPro™ is a standard product with a flexible, configurable architecture. The workflows can be modified to suit existing corporate structures.
  • The system can be integrated in the existing IT infrastructure on a platform-independent basis
  • It can be scaled as required and is suitable for any size of company
  • Comprehensive search and reporting functions, enabling export to MS Excel.
  • Possible linkage with an ERP system with the existing API interface.
  • Change history, escalation mechanisms, e-mail notifications etc. and integrated in CompliantPro™
  • Comprehensive support in the validation of CompliantPro™
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