AUDIT

Validera has extensive experience of performing audits of suppliers to the pharmaceutical industry. We also carry out all types of internal audits, as well as reviewing quality management systems and projects. Below are some of the typical audits we perform, among others:

• GMP audit on drug manufacturing facilities
• GAMP audit on suppliers of any kind of computerized systems
• ISO 9001:2000 audit
• Tick-IT och Sarbanes Oxley (SOx)
• Project audit

Activities included in an audit:

• Plan the audit and issue a detailed agenda which is communicated with the supplier
• Develop an audit protocol
• Execute the audit according to the audit protocol
• Write an audit report
• Follow up the deviations registered and perform a re-audit as necessary