SAP Consulting and Software Validation

Audit Management

Support, management and execution of internal and external audits

The objectives of an audit are examining and securing compliance with internal and external requirements, as well as identifying potential improvements to the process or (management) system. Here, various aspects have to be considered depending on the audit type: official audits (national / international), internal audits (self-inspections), certification audits (certification preparation), customer audits, system audits or supplier audits (supplier evaluation).

Based on many years of experience working in a regulated environment, DHC offers professional support in the management of audits, regardless of the type of audit. Our consulting services range from basic coaching, to management, to the implementation of the audits. This way, for example, an audit can be performed in preparation for an official inspection (e.g. FDA) or a topical one such as a 21CFR 11 Readiness Analysis.

We conduct our audits using a standardized method based on the regulatory requirements.

  • Support, management, conducting internal and external supplier audits with IT suppliers and IT service providers
  • Support, management, conducting internal audits (friendly audits) or quality checks based on IT processes, validated IT systems (e.g. in preparation for official audits)
  • Government-Audit Preparation (FDA, EU)
  • 21CFR 11 Readiness Analysis
  • Self Inspection
Header: ® AndreyPopov –