Quality Assurance

ZETA Quality Assurance

Quality assurance and qualification secure the defined quality of the system in terms of

 

  • material,


  • workmanship and


  • documentation,


and confirm its conformity to the specification and GMP.

Overview of ZETA Quality Activities

  • Creation of project-specific quality assurance and qualification concepts

  • Creation of test documents (material, mechanical, functional, electrical and software tests and documentation reviews)

  • Execution of tests of conformity with agreed quality standards (FDA, GAMP 5, ASME, AD2000, ATEX, DIN ISO)

  • Confirmation of conformity of the system to the specification and GMP

  • Compilation and handover of the project documentation and as-built Design documentation

  • GMP compliant production of the system

  • Qualification

Quality Assurance in Practice

Did you know that ZETA ...

...has 6 VT2 welding-, and 3 PT2 inspectors working in quality assurance?

...is a member in the American Society for Mechanical Engineering (ASME) committee?

...has 7 members from the International Society for Pharmaceutical Engineering (ISPE)?

...employees spent approximately 65.000 hours working on quality assurance in 2017?

...qualified approximately 20.000 isometric drawings in 2017?

...prepared over 400 folders of final project documentation?

...Executive Quality performed more than 60 vessel FATs in 2017?

 

 
 
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