Arcondis

Compliance Management

The number of regulations governing business is constantly growing and more and more industries have to fulfill legal requirements. However, compliance with these regulations should not be considered only from a cost perspective, but should also be seen as an opportunity to improve the quality and increase the efficiency of corporate processes. Identifying legislative changes in good time and implementing them quickly also brings important competitive advantages. The challenge lies in interpreting the regulations correctly, complying with them as efficiently as possible and avoiding duplication of effort. The appropriate frameworks should also allow new developments to be identified and adopted in good time.

Building blocks   Experience   Methods and tools
  • Enterprise risk management
  • Internal control systems
  • Total quality management
  • Quality management systems for GMP und IT
  • CSV guidelines, VMP
  • IT compliance framework
  • Security and risk management
  • Auditing
  • Continuous improvement
  • DMS and ECM
  • Software validation and infrastructure qualification
 
  • ECA validation specialists
  • Experts in standards and processes
  • CobiT Foundation
  • International Controller Association
  • Membership of the APV and GAMP DACH
  • Exchanging experiences within the IT compliance network
  • CPG SIG IT infrastructure
  • ITIL® in a GxP environment
  • CSV project simulation
  • Developing IT compliance frameworks
 
  • GxP, ISO 13485, REACH
  • SOX, EU SOX, OR 728a
  • ISO 9001:2000, EFQM
  • PDCA Deming cycle, QFD
  • FMEA, HACCP, ISO 14791
  • ISO 17779, GSHB, ISO 27001
  • GAMP 5, PIC/S, COSO
  • CobiT, ITIL®, ISO 12204
  • V model, traceability matrix
  • Infrastructure qualification package, IT SOP package
  • BWise, ARIS Audit Manager

ITIL® is a Registered Trade Mark of the Office of Government Commerce in the United Kingdom and other countries.

NewsFlash Nov 2011

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