OUR AUDITS FOR YOUR QUALITY ASSURANCE

We can help you to take advantage of audits and inspections as quality assurance measures through our support in the fields of GCP, GCLP, GLP, GMP, GVP, GDP, MPG.

Audit types:

• System- and project-related 
• Internal, external
• Routine or targeted (for cause/directed)
• Testing centres
• Sponsor
• CRO
• Phase 1 unit
• Suppliers
• IT-related

Quality assurance measures:

• Audit programmes
• CAPA tracking
• Training of study and project teams
• Support for customer and sponsor audits
• Mock audits
• Review of trial master files for regulatory submissions
• Due diligence
• External support in various QA functions

Inspections:

• Experience with FDA and EMA since 2005
• Pre-inspection audits
• Mock inspection audits
• Preparation, follow-up and support with inspections
• Training of study and project teams

Our qualifications include our experience with FDA, EMA, and country-specific regulatory inspections worldwide. Furthermore, we have extensive experience with inspections for regulatory approval of medicinal products and operating permits.

We are members of the following associations: RQA, GQMA, DGPharMed, ECA and SwAPP.

OUR AUDITS IN DETAIL

GCP

• Clinical Study Protocol
• Investigator Site (including Pre-Inspection Audits and FDA Mock Audits)
• Clinical Study Report
• Trial Master File
• Database
• Internal Systems
• External Systems (including CRO, Lab, Software Provider and Due Diligence)
  
  

GLP

• Pre-Clinical Study Protocol
• Study Conduct
• Pre-Clinical Study Report
• Internal Systems (eg. Facilities, Equipment, SOP Management, Archiving)
• External Systems (including CRO, Bioanalytical Lab and Software Provider)
• Bioequivalence Studies
• Method Validation (eg. microbiological, analytical)
  
  

GMP

• On Study, on Process
• Pre-Qualification Audit
• Qualification Audit
• Biologics
• Vaccines
• Master Cell Bank, Working Cell Bank
  
  

GVP/PV

• PV System (Marketing Authorization Holder (MAH), Affiliate (local), License Partner/Marketing Partner, Distributor, Service Provider, Disaster Recovery Plan)
• PV Documents (AdCO/PSUR, PSMF, RMP, SDEA)
• PV Process Audits (KPI, Reconciliation)
• PV Database
• ICRS Check
  
  

MPG/MedDev

• Software Validation
• Testing for Implants ISO 5840, EN12006 1-3, ISO 7198
  
  

IT

• Software Vendor Qualifications
• Validation Computerised Systems
• Specialised Service Provider