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Case Study.

Conducting audits.

Support with expertise and capacity.

The Challenge.

Ensuring the quality of your own internal and external value chain is a regulatory must. Auditors must be independent and have the right expertise in the required GMP or ISO regulations. The audit must be carried out carefully and reliably and finally documented.

Independent and experienced auditors were provided to conduct audits. Audits within companies were carried out carefully and conscientiously, and the audit performance and observations found were reliably documented. The reports served as a basis for the evaluation of suppliers and internal departments. Through the reports prepared and follow-up of the audits, very good qualification and monitoring of suppliers and internal departments could be demonstrated during inspections by authorities.

The Benefits.

  • Provision of independent auditors with extensive experience in required GMP and ISO standards
  • Auditing of company processes and quality systems according to appropriate GMP and ISO standards
  • Presentation and summary of the audit results in an official audit report
  • Audit follow-up and follow up on comments and proposed CAPA actions.
  • Consultation regarding the further qualification of the audited department or audited company

The Outcome.

Reliable audit results.

Reliable evaluation based on applicable GMP and ISO regulations.

Detailed audit report.

Official audit report for submission to authorities.

Solid basis for decision-making.

Decision for the qualification of the audited unit.

The Result.

Reliable auditing of suppliers and internal departments.