Quality assurance / Audit
  Due to EN ISO 19011:2003 and GCP-FDA guidelines we can offer the following services:
 
  • Management of an audit programme
  • Preparation of audits (predefinition of audit objectives, scope and criterias, preparation of an audit plan as well as generation of work documents)
  • Performance of audits (document review, collection and verification of information, reporting of audit findings, development of audit conclusions)
  • Analysis of audits including suggestions for improvement (preparation and distribution of the audit report as well as execution of audit follow-ups)

Audits serve as an independent and systematic review of quality-related activities and outcomes. They provide professional analyses of problems and weak points and are very helpful in the formulation of resolutions.
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