GXP Engaged Service Packages

Continuous QM coverage of internal client systems

• QM tasks for smaller companies that do not have their own QM staff, however, QA systems to be maintained.
• Support to companies with external, fully independent QA to evaluate compliance of operations and QA and support QA including QA system maintenance

Provide QA services for outsourced projects

• To companies who have no presence in the participating countries
• Surveillance of trial specific QM plans, non-compliance/CAPA follow-up and regular (e.g. monthly) report of trial compliance situation

Trial specific QM plans

• Defined quality metrics / KPIs selected in mutual agreement with the client
• Evaluation of new and ongoing issues recorded on study tracker system
• Review of final monitoring reports
• Review of suggestions for corrective and preventative actions (CAPAs)
• Surveillance of audit CAPA progress and confirmation of CAPA close out

Audits

• To critical suppliers
• To investigational sites
• Of essential documents

Depending on the scope and complexity of the programme, audits are often performed in teams, together with co-auditors from GXP Engaged Auditing Services or the sponsor. Auditors with particular experience in certain areas (i.e. pharmacovigilance, electronic data capture and so on), are involved, if needed. Audits are conducted using tools which are adapted for the specific requirements of a study or system. Worksheets are shared with clients if so desired. Audit reports are written within defined timeframes, peer-reviewed, released and distributed as agreed. The auditors' follow-up action can either be executed by the sponsor or the GXP Engaged auditor; however, a formal signed communication that all findings have been addressed is always considered a part of the audit.

If more complex audit projects are planned, a project specific audit SOP may be deemed necessary and statistical evaluations on audit findings can help to prioritise preventative actions.

Quality Emergency Hotline

• Questions for the sponsor related to ICH-GCP and other applicable regulatory standards relevant for the target countries and the trial under investigation, answered within 24 hours