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Software is a significant investment, whether you are coding your own, purchasing for in-house installation, or accessing it on line. This is especially true for FDA regulated companies, because you need to meet compliance requirements for the software that tracks these activities. This must be balanced against the risks of not having software.

When assessing operations (calibration, validation, and/or maintenance) management software, especially for GxP applications, compliance is an important, but not the only important endpoint. Meeting GMP, GCPor GLP requirements (including 21CFR11) for your validated calibration management softwareis the baseline requirement.

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