Compliance Audit at GXPi
“Working with Mark and his team, we were able to complete a full gap analysis of our current project delivery processes and prepare an action plan to introduce the necessary changes.” Consulting Director Crossgate

Compliance Audit

Structured GXP compliance audit packages focussed on quickly identifying issues and establishing pragmatic risk-based action plans to implement the necessary improvement actions.

  • The purpose of our audits is to help our customers understand where they are right now and where they need to focus their resource in order to be even better
  • Team of 10 auditors available all with 15+ years experience covering GMP, GDP, GCP, GLP, GCLP, GAMP® computer systems compliance
  • Established audit methodology providing a ‘roadmap to compliance’
  • Auditing to EU (EMA), US (FDA), UK (MHRA) regulations and international guidelines such as ISPE GAMP® and ICH
  • Standard audit modules or tailored packages available using tools and templates
  • Fixed price audit services
  • Audit training available

Case Studies

  • Case Study: GCP Compliance Audit and Action Plan Download

Presentation Papers

  • ICH Q6B - Implications for developers of biopharmaceuticals Download
  • Validating an EDMS - the lean and simply compliant way Download
  • The paperless QMS Download
  • Brussels GAMP; Regulated Applications In the Pharma Cloud Download
To find out more or to discuss your requirements please contact us by calling +1 713 589 4824 or email: info@gxpi.com