The Quality is already there,
we just visualize it

Our Service

Qualification

Part of the team and together for GxP-Compliance

  • Qualification concepts with a strong focus on a lean, risk-managed and integrated approach
    • URS and Design-Review for added value plus 2-staged FMEA
  • Project management consultancy for Commissioning & Qualification (C&Q)
    • Troubleshooting - ongoing projects
  • Coordination of the project team members and a high quality reporting from day one until and beyond the handover

Integrated Approach

Part of the team and together for high quality standards

  • no redundancy in documentation and testing (right first time)
  • state of the art integrated procedures and selected best practices from our experience
    • qualification object structure - Traceability in multi-use - supplier documentation - quality gates
  • communication center during the project execution
    • coordination of all qualification project phases to hand-over

Quality in Projects

A solid documentation of user requirements is crucial to qualification success. Therefore, our earliest possible involvement contributes directly to overall project success.

A clear and structured project scope enables progress measurement during execution. Consequently, we use our qualification documents in parallel as progress reports. This ensures a cost- and resource-efficient project.

The controlled execution of planning ensures GMP compliance of the facility. We review not only ALCOA+ attributes, GDocP-compliant document managment as well as change and deviation management.

Our Team

Philipp Weißenböck

Ing. Philipp Weißenböck M.Sc.

Project Quality Manager / Managing Director
Experience: 10+ years

  • Yellow Belt Six Sigma & SCC
  • Plan, lead and execute DQ, FAT, SAT, IQ, OQ, PQ & reports 
  • Project Management
  • GMP Documentation Management
  • Expertise in cleanroom- / TCU- and equipment qualification

 

Martin F. Ortner

Martin F. Ortner

Project Quality Manager / Managing Director
Experience: 10+ years

  • Project Management, Qualification Strategy Expert & Troubleshooting
    • Track & Trace: from URS and Risk Assessments via DQ, IQ‑OQ‑PQ / TM to reports
  • Trainings in Lateral Leadership, CSV and Auditing
  • CPRE FL by IREB

 

Lukas Herrmann M.Sc.

Project Quality Engineer
Experience: in progress

  • basic understanding of Qualification Projects and GMP frameworks

 

Fa. GMP Doc GmbH

Buchenweg 4
A-3451 Streithofen
office@gmpdoc.at

UID: ATU79766139
Gerichtsstand: St. Pölten / NÖ
FB-Nr.: 610384z