IT / CSV Auditing

Quality Assurance Auditing

With our years of experience in IT Quality Assurance and working with people from all levels of global pharmaceutical organisations from the CEO to the factory floor we can assist you with our varied range of IT Quality Assurance Services. Whether you need help and support with a specific audit / audits, or outsource your IT QA audit schedule.

Whether its supporting your internal auditors as an audit team member, leading your internal audit team, or conducting audits using our network of independent Quality Assurance auditors we can meet your requirements. We have experience in auditing IT and Clinical, Laboratory and Manufacturing System Suppliers, Clinical Research Organisations, Clinical Data Management, eCRF, Laboratory Management, Medical Imaging, Interactive Response Systems, Clinical Distribution suppliers, Electronic Patient Diaries / EPRO systems, and contract manufacturers.

Our ITQA and Computer System Vadliation audits, can be included as part of our wider general vendor audits services

Our auditing services include:

• Development of Audit Plans/Agendas.

• Conducting Onsite Audits (either as Lead Auditor or team member).

• Audit Observation Write-up and Reporting.

• Review of Auditee CAPA Responses.