Case Study.

Conduct mock audits.

Effectively prepare for government inspections.

The Challenge.

In preparation for inspections by the authorities, production processes, quality systems and internal documentation must be correctly set up and clearly presented. Depending on the inspection, the focus may be on products or general company processes. All-embracing preparatory measures must be taken and any discrepancies identified and rectified in advance. The interaction of the individual company processes must be taken into account and, at the same time, the daily routine in the specialist departments must be checked in detail. In the mock audit described above, targeted spot checks were carried out and the systems and processes were examined in detail. Non-conformities were identified and could be proactively remedied. Employees were coached and trained in the presentation of systems, documents and data in order to be able to present them correctly in the audit situation. In addition, awareness of the agency's requirements and pharmaceutical regulations was raised within the company.

The Benefits.

  • Auditing of the all-encompassing company processes and quality systems according to strict pharmaceutical standards
  • Recording of non-conformities and advice on determining appropriate CAPA measures.
  • Follow-up of the implementations carried out through regular check-ups in the individual areas
  • Advice regarding the focused and effective preparation of data and documents
  • Coach and train staff on convincing presentation of internal processes and systems and related documents and data
  • Support in the preparation of required risk assessments

The Outcome.

Audit Readiness.

Focused and effective preparation of data.

Routine inspection support.

Confident presentation of company processes and systems.

Very good inspection result.

Improve inspection results by proactively addressing non-conformances.

The Result.

Audit readiness and very good passing of authority inspection due to good preparation and proactive resolution of non-conformities.