Quality – our input for your success

Engineering and qualification out of one hand:

  • product specific process-risk-analysis during conception phase
  • clear design documents for efficient and just in time project performance with consolidation of established sub-suppliers
  • definite structured qualification documentation corresponding with your specific requirements
  • professional machine qualification for a high degree of product quality and patient care
  • transparent qualification process through consequent implementation and backtracing of detected risiks and resulting activities
  • we accompany the qualification process through design, installation and acceptance (FAT/SAT) with the goal, that your equipment will go into production in schedule and in qualified condition
  • due to our independence we can choose the optimized machines and processes for your products, as well as take your quality requirements into consideration

DESIGN QUALIFICATION
(DQ)

qualification of machine design

INSTALLATION QUALIFICATION
(IQ)

qualification of machine installations

OPERATIONAL QUALIFICATION
(OQ)

qualification of machine functions

PERFORMANCE QUALIFICATION
(PQ)

qualification in production condition

machine concept

design
risk-analysis

machine execution

installation
documentation

machine function

function tests
simulation

machine performance

production tests
product quality

Business activities:

  • machine- / equipment qualification
  • process and system validation
  • software validation (GAMP 5, 21 CFR Part 11)
  • creation of technical specifications
  • SOP and masterplan preparation
  • risk and process analysis
  • to-be-analysis of GMP-systems
  • re-validation of modified systems
  • preparation of audits
  • consulting, training