Eolus® Compliance Solutions : Audits

Eolus audits help clients identify their specific areas of risk regarding quality and compliance of systems, procedures, documentation and controls.

Our auditors are called upon to perform ISO audits, mock FDA inspections, quality system audits, vendor qualification audits, site audits, security, and other systems and quality audits including GCP, GLP, cGMPs, and QSR audits. 

During the audits, we review applicable documentation, interview key quality assurance, support and management personnel, and address the following regulatory issues:

• Company organization
• Quality management systems
• SOPS, policies and guidelines
• Personnel qualifications and training records
• Design Control records
• System design and specification
• System development/implementation
• Testing
• Change control
• Quality assurance
• User documentation
• Installation and maintenance
• Disaster recovery and business resumption
• Security policies and procedures
• Facilities management

A written audit report summarizes the results and provides the client with specific recommendations to mitigate any technical or regulatory risks discovered.

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