There are SAP components like SAP Learning Solution, SAP Recipe Management , SAP Environment, Health & Safety (SAP EH&S) application etc which has compliance with U.S. FDA Title 21 CFR Part 11.
The FDA requires the ability to log and track changes on business objects and dependent objects in a compliant software environment. This is provided by [...]
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There are certain compliance methodologies set by the state bodies for Pharma companies as they deal with the production of life saving drugs and equipments. Here we discuss about the SAP validation and compliance methodologies in Pharma companies. The validation procedure is almost same as for other industries, just there are additionally some guidelines set by governments of the states that need to be followed. [...] The blog describes about the SAP EBR(Electronic Batch Recording) functionality for process industries like pharmaceutical, chemical and food industry. It describes what is SAP EBR and its significance in different [...] The blog describes about the SAP validation environment for pharmaceutical industry. It describes the scope of validation for different Regulatory bodies for Pharmaceuticals industry and V model for [...] |
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