Precision to the last detail

GXP Engaged Service Packages

Audit Programmes

  • of investigational sites
  • of critical suppliers
  • 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 either GXP-Engaged or sponsor standard procedures and tools. Audit agendas and reports are written within defined timeframes, peer-reviewed, released and distributed as agreed. The auditors' follow-up action can be executed by either the sponsor or the GXP-Engaged auditor.

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

Inspection Preparation and Support

  • of investigational sites
  • of critical suppliers
  • of sponsor companies
  • of key documents

Due Diligence Audits

  • of companies
  • of documents
  • of data

Support of Client QM Systems

  • Gap analysis of client QM systems
  • Revising and/or setting up and implementing QM systems in client companies, including SOPs
  • QM tasks for companies without sufficient staff to maintain established QM systems

Trial-Specific QM Plans

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