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The initials of the reviewer and the date of review should be indicated.
If data sets are entered automatically through an electronic interface, then the transfer link between the spreadsheet application and the source of the data must be validated.
3 References 4 Introduction Spreadsheets can be used to record and manipulate (change, delete, add) Gx P data and as such need to be managed to ensure the continued integrity and security of that data.
While some are no more than fancy calculators others are embedded with special features and use intricate logic in the form of Macros that are in effect computer programs.
Similarly, data from a spreadsheet must not be exported to a validated computer system/application unless the transfer link has been validated and the importation approved via change control for the receiving system.
5.2.2 Formula Development Each formula described in the Requirements Documents must be embedded in the spreadsheet application.
Spreadsheets which fall into GAMP Category 3 guidelines (Table 1) do not require full validation activities but should be held under appropriate security conditions.
Spreadsheets which have calculations that are fully explained on the spreadsheet and which undergo verification with each use do not need to be fully validated, however where there are templates for the spreadsheets appropriate security conditions, including password protection should be provided.
This will impact the level of validation effort that is applicable just as with other computerized systems.
The Functional Requirements Document should contain applicable sections to describe: 5.1.1 Review and Approval of Functional Requirements The functional requirements should be submitted to the Validation Manager for technical approval, to Quality Assurance for regulatory compliance, the Local Area Network Manager (if applicable) and to the Area Manager for overall approval.
5.2 Spreadsheet Application Development The Spreadsheet Application Developer will devise the spreadsheet application parameters, such as the way the table looks, data formats, data sorting parameters, the addition of fields to the spreadsheet application, reports, formulas and interfaces with other programs and instrumentation.
D., is the director of Labcompliance and editor of ( the global online resource for validation and compliance.
He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”.