International Standards
IT and Software
These are the most adopted international IT and Software standards.
ISO 20000
IT and Software
ISO 20000 is the first international standard for Information Technology Service Management and is fully compatible and supportive of the ITIL (IT Infrastructure Library) framework.
21 CFR part 11
IT and Software
21 CFR part 11 defines criteria under which the United States Food and Drug Administration (FDA, a/k/a Agency) considers electronic records and signatures trustworthy, reliable and equivalent to paper records and handwritten signatures, respectively. It applies to records electronically created, modified, maintained, archived, retrieved, or transmitted under any records requirements per FDA regulations.
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