Validation & Regulations

My knowledge and years of experience within the Validation & Regulatory in the Life Science industry is at your disposal. As chairman of the ISPE Community of Practice "GAMP Benelux” and as a consultant / Black Belt, I had the opportunity to further this improvement.

The following services at a fixed price or hourly basis are available:

  • Performing a Compliance Scan (GMP, 21CFR part 11)
  • Conducting audits of your suppliers
  • Conducting "mock audits” for your business
  • The planning and execution of validation activities
  • Implementing Lean Validation
  • The drafting and reviewing project documents and procedures (GAMP )
  • Risk Management (FMEA)

The diagram shows an overview of the available documents from the GAMP family, devided over the automation landscape as defined in the ISA-95 standard..

GAMP Structure