Validating excel spreadsheets

This guidance outlines steps that shall be followed to request, approve, develop, test, implement, maintain and support a controlled spreadsheet application.5 Validation of a Spreadsheet Application 5.1 Functional Requirements Development Spreadsheet applications may be developed by individuals (e.g., laboratory analysts) who have been qualified by training or experience as a Spreadsheet Application Developer.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.For automated operations, raw data will be input directly from the instrument to the spreadsheet application.If data sets are entered manually, all entered data must be reviewed by a second individual to verify the correctness of the entered (transcribed) data.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.

5.2.4 Macro Programming Frequently performed tasks may be automated by recording them as macros and playing them back whenever necessary.These areas include but are not limited to: The scope does not include those spreadsheets which are single use only (prepared for a specific, one off tasks) or those which are used for organization of personal, or departmental work plans.These should be verified at each time of use as appropriate.Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s Gx P and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.

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