Case Study.

Implementation of a company internal audit system.

System for effective review of internal departments.

The Challenge.

Production processes and quality management systems in pharmaceutical companies must be continuously monitored in accordance with regulatory requirements. When setting up the internal audit system, product and production-related departments were assessed and classified according to their criticality. Based on this, it was determined internally how the continuous monitoring is to be carried out and how the internal escalation mechanisms function. Software was established for clear documentation, in which any non-conformities found can be clearly recorded and the implementation of measures can be effectively tracked.

The Benefits.

  • Structuring and risk-based classification of internal departments into subareas to be audited
  • Establishment of an achievable and effective audit routine
  • Establish a suitable system for documenting audit observations and tracking CAPA actions.
  • Establishment of an internal information and escalation system
  • Establishment of a suitable training process for internal auditors

The Outcome.

Effective internal control mechanisms.

Reliable and effective monitoring of internal departments

Audit Management Software.

Clear audit planning and processing.

Maintaining continuous quality.

Sustainable quality awareness of employees through a lived system.

The Result.

Effective internal audit system for stable internal quality.