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. 2022 Dec;117(12):1420-1445.
doi: 10.1111/vox.13332. Epub 2022 Oct 26.

International Society for Blood Transfusion Guidelines for Validation of Automated Systems in Blood Establishments

Jan-Willem Andriessen  1 , Michael Breard  2 , Lynne Briggs  3 , Suzanne Butch  4 , Patricia Distler, Jørgen Georgsen  5 , Shankar Goudar  6 , Teemu Laakso  7 , Robin Nozick
Affiliations

International Society for Blood Transfusion Guidelines for Validation of Automated Systems in Blood Establishments

Jan-Willem Andriessen et al. Vox Sang. 2022 Dec.
No abstract available

Keywords: GMP; IT security; application validation; assessment; infrastructure qualification; risk; supplier qualification.

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References

REFERENCES

    1. GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems. ISPE. 2010.
    1. GAMP Good Practice Guide: IT Infrastructure Control and Compliance. ISPE. 2017.
    1. GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerised Systems. ISPE. February 2008.
    1. ICH guideline Q9 on quality risk management. 2022. Available from https://www.ema.europa.eu/en/documents/scientific-guideline/internationa...
    1. Good Practices for Computerised Systems in Regulated ‘GxP’ Environments. PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme. PI 011-3. 2022. Available from https://picscheme.org/docview/3444

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