An audit is an evaluation of a person, organization, system, process, project or product. Audits provide an assessment of an internal control of the system and are performed to ascertain the validity and reliability of information. The goal of an audit is to express an opinion on the person/organization/system etc. under evaluation based on work done on a test basis. Due to practical constraints, an audit seeks to provide only reasonable assurance that the statements are free from material error.

Overview about autit activities:

• Preparation of inspections in pharmaceutical quality system, AMBO-regulation for pharmaceutical plants (GMP-certificate, GDP-certificate)
• Preparation of inspections in clinical trials (GCP)
• Preparations of internal audits
• Performance of system audits, process audits, product audits, project audits
• supplier audits– GDP, GMP
• Quality audits clinical study site– GCP
• self-inspections regarding AMBO (regulation for pharmaceutical plants)
• audit documentation - plan, agenda, report, action plan, certificate
• consultancy in corrective and protective actions