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Supporting the pharmaceutical industry with EU Annex 11: Computerised Systems compliance readiness

X-ray systems

The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the EudraLex Volume 4 Annex 11: Computerised systems regulations issued by the European Commission.

Integration of PANalytical systems in an Annex 11 compliant laboratory environment is straightforward because PANalytical offers tools and services to guarantee authenticity, integrity and confidentiality of electronic records and electronic signatures. Also, the final system qualification is supported with products and services.

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