21 CFR - Pharmabeej

50 Electronic Codes of Federal Regulation (e-CFR) in pharma

As per FDA there are 50 title of Electronic Codes Of Federal Regulation (E-CFR) In Pharmaceutical. In this article we will see the all 50 title of electronic code of federal regulation. Electronic Codes Of …

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Important Difference between 21 CFR part 11 and EU Annex 11

by Pharmabeej

21 CFR part 11 and EU annex 11 both are guidance for the electronic records and electronic signature. The guidances are applied to the computerized systems that used to store the electronic data. FDA has …

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Best practices to avoid Data integrity issues and ALCOA plus

by Pharmabeej

Data integrity and Alcoa plus in pharmaceutical