Quality assurance


We can assist you various operational quality assurance tasks. We provide tailor-made services to efficiently support the following quality operations:

  • Implementing the latest industry standards and trends: ICHQ8/Q9/Q10, FDA Guidance for Industry
  • Change control, deviations, CAPA, complaints and OOS analysis and remediation
  • Risks analysis
  • Root cause analysis
  • Periodic review
  • GMP documentation streamlining (SOP, Batch record,...)
  • Support with respect to regulatory events such as recalls or warning letters

As lead or support, we provide support in Audit:

  • Quality system
  • Computerized System Auditing
  • 21 CFR part 11 Compliance
Quality image resized