Projection of installations and machines

  • Deadline control of projection and qualification processes,

  • Creation of tenders and software specifications, flow charts, technical specifications as well as installation and operation descriptions,

  • Conception and documentation of maintenance tasks,

Qualification of installations, machines and process

  • Development of qualifications and validation concepts,

  • Organization and realization of risk analysis,

  • Conception and realization of DQ-, ID-, OQ, and PQ phases,

  • Summary and validation of qualification measures

Documentation

  • Creation of GMP-conformin documents,

  • Set up of a documentation and archives structure,

  • Development and/or modification of IT-based document management systems,

  • Control of completeness of the documentation (specify actual condition),

  • Consulting and training at initiation of document management systems

Work under clean room conditions

Reinraum

qualifizierung en