Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 19: Writing the Technical Specification
Published:23 Nov 2016
The technical specification defines the computer platform components (hardware, software, data storage, etc.) that a CDS will run on. For a standalone system involving a single workstation this can be incorporated adequately in the URS, but this is not recommended for regulated work. For multi-user systems housed on one or more servers in a data centre or computer room, a technical specification is required.