Auditing

Ready for your next regulatory inspection?

HaaPACS provides audits with different focuses:

• Process Audits (SOPs, GCP-Compliance)
• Audits for Computer Systems (Project Management, Validation) 
• Vendor Audits

All audits will be performed by the Managing Director, Dr. Uwe Haag. Dr. Haag is having a broad education and extensive practical experience in Clinical Data Management, IT and Validation of computer systems. He is also member of an industry expert council for computer system validation.

Depending on our customer requirements, audits will comprise:

• Individual and specific audit preparation according to customer requirements
• Announcement of the audit
• Preparation of an audit schedule
• Conduction of the audit
• Preparation of a draft report
• Revision of the report after review by the customer
• Revision of the report after comments of the audited organisation
• Follow up and follow up consulting  

To learn more see also audits in our section References & Case studies