“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
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