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 and GAMP® computer systems compliance
- Established audit methodology providing a 'roadmap to compliance'
- Auditing to EU (EMEA), 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
ICH Q6B -implications for developersof biopharmaceuticals
Validating an EDMS – the lean and simply compliant way
Brussels GAMP Regulated Applications in the Pharma Cloud GxPi
LinkedIn Simple Compliance Group
US Food and Drug Administration (FDA)
UK Medicines and Healthcare products Regulatory Agency (MHRA)
Get In Touch
Call us:
+44 115 924 8475
+49 751 35450 892
+1 973 917 3965
