Precision to the last detail

GXP Engaged Auditing Services

GXP Engaged Auditing Services provides global QM Auditing and Consultancy Services
through its network of Quality Management professionals.

GXP Engaged Auditing Services offers help in ...

  • Audits covering all areas of (pre-)clinical research
  • Quality Assurance consultancy (with global GXP QA expertise)
  • Inspection preparation and support programmes
  • Due diligence for GXP compliance
  • Support in revision QM systems (incl. QDs writing)
  • Set-up and execution of QM and Auditing plans
  • Independent QM/QA coverage of client companies

++++++ COVID – 19 ++++++

Regulatory Guidelines Review

Global Health Authorities have introduced guidelines for clinical trials due to COVID-19. GXP Engaged invite you to access our review of approx. 60 of these guidelines covering aspects affected by the pandemic such as the provision of IMP/Supplies to subjects, Subject Visits, Informed Consent, Monitoring & Remote SDV, Sponsor Risk Assessments, Protocol Deviations & Amendments, Safety Reporting etc.

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++++++ COVID – 19 ++++++

Remote Audit Concepts

The thoughts of the staff at GXP Engaged are with all those affected by COVID-19, the patients and their families, nurses, doctors and all those on the frontline helping to take care of the sick.

As a courtesy, to help our valued customers, we would like to present our remote auditing strategy papers for RISA, Remote Investigator Site Audits and REVA REmote Vendor Audits, strategy papers which can be included as part of a Risk Based Approach to auditing at this time and beyond.

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