What is CSV, VP? Difference between 21CFR part 11 and EUannex 11? Gamp5 ?

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CSV stands for comma-separated values, VP is validation protocol. 21CFR part 11 and EU annex 11 are regulations for electronic records and signatures in the US and EU. Gamp5 is a guideline for validation of computerized systems in the pharmaceutical industry.

CSV is a file format used for storing tabular data in plain text, with each line representing a data record and each record separated by commas.
VP is a validation protocol used to ensure that a system or process meets predefined requirements and specifications.
21CFR part 11 is a regulation by the FDA in the US that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
EU annex 11 is a regulation in the EU that provides guidance on the requirements for electronic records and electronic signatures in the pharmaceutical industry.
Gamp5 is a guideline published by ISPE for the validation of computerized systems in the pharmaceutical industry, outlining best practices and approaches for ensuring data integrity and system reliability.

What is CSV, VP? Difference between 21CFR part 11 and EUannex 11? Gamp5 ?

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