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Spreadsheet Validation White Papers

Listed below are a number of published papers that detail how we undertake spreasheet validation. They are a useful starting point for undertstanding the scope of your project and how we can bring our expertise and experience to help you.

Pragmatic Validation

David Harrison of CSV Compliance authored a mini series of papers on spreadsheet validation. All three papers were published in the Pharma IT journal and are available for download below. The first paper provides an overview on the topic of spreadsheet validation.

Spreadsheet Specifications

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This paper provides a detailed account of what needs to be specified when validating your spreadsheet. It defines the basis of your User Requirments and Functional Specification. This explains to an auditor what your spreadsheet does and how it does it.

Spreadsheet Testing

This paper walks the reader through how we test Excel spreadsheets to give a high degree of assurance that the spreadsheet functions as it was designed to. It shows our unique testing methodology to ensure maximum stress testing with minimum workload.

FDA Spreadsheet Validation Expectations

This document provides a very detailed overview of what the FDA expect to see when you validate a multi user spreadsheet (i.e. a spreadsheet that is used multiple times, or by multiple users, such as a spreadsheet template). It is an internal FDA procedure (Laboratory Information Bulletin).

FDA Spreadsheet Verification Expectations

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This document provides a detailed overview of what the FDA expect to see when you use a single user spreadsheet. This method of spreadsheet use is not however very common in regulated industries. The document is an internal FDA procedure (Laboratory Information Bulletin).

CSV Compliance Review of FDA Documents

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The Laboratory Information Bulletin on this page are fully inclusive. However they are now quite dated (2001 and 2005) and the industry approach to validation has moved on since then. We would recommend a more pragmatic approach and set the industry standard with the white papers above.