Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 30: User Account Management
Published:23 Nov 2016
Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements, The Royal Society of Chemistry, 2nd edn, 2016, pp. 586-597.
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Owing to the data integrity issues discussed in Chapter 7, user account management must now assume a greater priority with a chromatography data system. In the first edition of this book, user account management was discussed within the section on IT SOPs, here it has a whole chapter devoted to the subject. After discussing the regulatory requirements, we start with defining accounts and assigning a user role that will typically be performed by an IT group outside of the laboratory. Then, if required, laboratory administrators will be involved, defining the projects, chromatographs and data that an individual user can have access to.