Qualification

ZETA Qualification

Quality assurance and qualification verify the quality of the system as ordered in respect of material, craftsmanship and documentation and validates the conformity to specifications and GMP.

Experienced employees are available to work on-site both in ZETA projects and as a separate service for ZETA customers.

What ZETA Does

ZETA works in accordance with the current understanding of GMP guidelines and complies with the applicable regulations, stipulations of regulatory authorities, recommendations from expert committees and recognised literature. Our customers can benefit from the experience and advice of specially trained employees on quality-assurance and qualification procedures. We are also happy to handle special requests from customers.

Customer Benefits

  • GMP compliance
  • Fully traceable documentation
  • Simple, logical structure
  • Support for the systems after project completion
  • Qualification to ZETA or customer’s own standards

Qualification in ZETA Projects

  • Preparation of qualification concepts
  • Risk analyses
  • Creation of qualification plans
  • Execution of qualification tests
  • Support for PQ
  • Operator training on the system
  • Creation of SOPs

Qualification Service

  • Qualification of third-party equipment
  • Provision of qualification teams to support customers on site
  • Development of qualification strategies
  • Preparation of qualification concepts
  • Risk analyses
  • Creation of qualification plans
  • Execution of qualification tests
  • Qualification to ZETA or customer’s own standards
 
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