Cloud based solutions need an adapted approach for Computer System Validation (CSV). Our Validation Partner Chemgineering Business Design GmbH supports you in validated and qualified operations of the UDI Platform Solution.

Validation Partner

Chemgineering is your partner for compliance topics. As experts for validation and qualification Chemgineering supports your way to the Cloud.

Validation Package

Chemgineering provides a Validation Package for the UDI Platform of p36.labs.
It is based on a CSV approach adapted to the UDI Platform and the specific requirements of the medical device industry to:

  • Introduce and operate the UDI Platform Solution in accordance to the regulatory requirements in Europe and overseas
  • Auditing and audit-proof operating the UDI Platform Solution
  • Pre-built Life-Cycle Documents

The Life-Cycle Documents include:

  • URS-Template
  • Validation-Plan (VP)
  • Risk-Analysis  (RA)
  • Trace-Matrix (TMX)
  • Test-Templates for IQ / OQ and Acceptance tests (PQ)
  • Pre-built final reports for IQ / OQ and PQ
  • Pre-built Validation Report (VR)
  • Examples for User-SOPs (e.g. Administration, Change-Control, Data security, Disaster-Recovery, SLA-Monitoring)

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