Gxp software validation
[DOC File]Standard Operating Proecedure - Meta-X
https://info.5y1.org/gxp-software-validation_1_8c8f4b.html
A computer system consists of computer hardware, software, operating environment, associated data, and documentation to perform a GXP or regulatory submission function. Policy Computer systems …
[DOCX File]User Requirement Specifications
https://info.5y1.org/gxp-software-validation_1_8b8024.html
Validation of method. ... Validation of software. Test that software can be used in the intended manner for the described process and that the outcome of the software can be trusted. ... The ELN full audit trail must support CFR 21 part 11 for regulatory compliance with GxP …
[DOCX File]SOP Custom Development - SDLC - Validation Center
https://info.5y1.org/gxp-software-validation_1_bd3238.html
Provides GxP compliance for regulations not already identified as “High Criticality” ... General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA, January 11, 2002. Glossary of Computerized System and Software …
[DOC File]resume plus
https://info.5y1.org/gxp-software-validation_1_32596d.html
software validation studies. Responsible for QA and QC in the division. Assisted in the preparation of device-related regulatory submissions for the U.S. and Europe. Assisted with European submissions …
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