according DQ IQ OQ guidelines
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 license.
Design Qualification (DQ)
✔ Description of software and hardware function
✔ Verification if the instrument is meeting the specification especially in terms of functionality
Installation Qualification (IQ)
✔ Check of the scope of delivery
✔ Instrument installation
✔ Verification of the document completeness
Operational Qualification (OQ)
✔ Functions of the machine is meeting the proved criteria
✔ Verification if all security-related functions are fulfilled
