“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 focused on quickly identifying issues and establishing tailored risk-based action plans to implement the necessary improvements.

  • Team of 10 auditors available all with a minimum of 20 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
  • Options available for audits to be conducted at customer site or remotely using web conference facilities
  • GXPi Readiness Assessment – for customers wishing to embark upon an EDMS implementation project

Case Studies

  • Case Study: GCP Compliance Audit and Action 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
To find out more or to discuss your requirements please contact us by calling +44 115 924 8475 or email: