IT / CSV Quality Assurance Services

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.

IT QA Outsourcing - New Service for 2009! 

If you may have a requirement for multiple IT QA audits (but still not enough to keep an employee fully occupied), or if you are not quite sure where in your audit schedule IT QA resources may be advisable, why not let us take care of it for you. When you outsource your European IT QA portfolio to A1 IT Compliance, we become an integral part of your audit schedule and resource management. The service can be customised to meet your exact requirements, and in addition to the peace of mind of knowing your biggest risks areas will be audited appropriately, you can also ensure your ITQA resources go further by taking advantage of our sliding audit fees (the more you use the lower the average audit price). 

Our IT Quality Assurance outsourcing solution can include any of the following components:

• Risk-based Assessment of your Vendor and System Audit Schedules
• Attendance at Audit Schedule Management Meetings
• IT Quality Assurance Resource Management
• Audit Report Review (for IT Quality Assurance Observations identified by non ITQA personnel).
• Review of Auditee CAPA Responses

ITQA Auditing

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 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