Audit Support: Securing Reliable Audit Results
Life sciences company with its own internal and external value chain
Provision of independent, experienced auditors to conduct audits to GMP and ISO standards, including report writing and CAPA follow-up.
The challenge
The situation
Ensuring the quality of a company's own internal and external value chain is a regulatory must. Auditors must be independent and have in-depth expertise in GMP and ISO standards. Audits require careful execution and reliable documentation of the findings.
Our approach
What we delivered
Provision of independent, experienced auditors for GMP and ISO standards
Auditing of company processes against the applicable standards
Preparation of official audit reports in a form that holds up when submitted to authorities and makes the assessment traceable for third parties.
Audit follow-up with tracking of the CAPA actions through to closure, so that findings do not remain in the report but are actually resolved.
Advice on the further qualification of the audited unit, so that the audit result becomes a sound basis for the decision.
The outcome
Results & impact
Dependable assessment
Dependable assessment based on the applicable GMP and ISO regulations.
Official audit report
Official audit report for submission to authorities.
Qualification decision
Basis for the decision on qualifying the audited entity.
In summary
Dependable auditing of suppliers and internal departments, backed by independent expertise and additional capacity.
Regulations & standards considered
- EU-GMP
- ISO 9001
Related expertise
GxP Audits (GMP, GLP, GCP) →
Planning and conducting audits in line with GxP requirements.
ISO Audits (13485 & 9001) →
Audits against ISO standards alongside GMP/GxP audit expertise.
CAPA Management →
Tracking and managing corrective and preventive actions after the audit.
Supplier Development & Qualification →
Assessment and qualification of suppliers as part of the value chain.
Good Manufacturing Practice (GMP) →
Support in complying with the applicable GMP standards.
Similar projects
More on Pharma →
Sources
- https://theentourage.de/case-study/audit-unterstuetzung-experten/ (live case study, accessed 2026-06-14)
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