In pharma and medical technology, the validation of machinery cannot be ignored. According to EU-GMP guidelines, manufacturers of pharmaceuticals got instructed to confirm that the used machinery is suitable for the intended purpose.
GOETTFERT is providing support for validation and documentation of Design Qualification (DQ), Installation Qualification (IQ) as well as Operation Qualification (OQ). This purpose-built document will be proofed during authority audits in terms of extension of the manufacturing licence.
Design Qualifikation (DQ)
Installation Qualifikation (IQ)
Operational Qualifikation (OQ)