Governance, Risk & Compliance

Compliance does not have to be difficult and complicated. We can help you simplify complexity and use our GRC model to easily manage your requirements.

Governance & Compliance

Compliance means the conformity of a quality management system (QMS) or an internal control system (ICS) with legal regulations and standards. Compliance is verified by external bodies, e.g. in the form of ISO certifications, within the scope of approvals or through inspections. An essential aspect of compliance is therefore auditability, i.e. the corresponding verifiability and documentation of the required processes and controls.
We support you both in the implementation of new compliance goals and in the adaptation, standardization and simplification of existing compliance systems.

Based on the process-oriented approach to the integration of compliance, risk and quality management developed by add7, we optimise your expenses in the compliance area by

  • Unification of the underlying process landscape
  • Harmonization of process controls
  • Simplification of documentation
  • Building synergies for maintenance of CRQ systems and compliance documents

For new compliance initiatives, we support you from conception to implementation:

  • Ascertaining your compliance requirements
  • Analysis of the existing QMS or ICS
  • Drafting suggestions for improvement
  • Planning the implementation
  • Supporting the implementation project
  • Preparing and supporting the certification

GxP validation

The add7 GxP IT compliance package thus enables an unrivalled fast and cost-effective implementation of the IT QMS required for validation and the timely definition of the validation process.