Arizona

Spreadsheet Development & Validation

Make your existing spreadsheet Part 11 compliant, avoiding the need to move to expensive enterprise systems.

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SPREADSHEET  OVERVIEW ​

Spreadsheets are often used to perform GMP–related calculations, trend data, plan calibration and qualification work, and manage laboratory assets.

Spreadsheet developed as per regulatory compliance should eliminated possible risk from performing GXP work to increase business efficiency and reduce regulatory risk.

​ Spreadsheets are used to collate lists of instruments and perform a multitude of calculations in many regulated laboratories. But spreadsheets also present an auditing and inspecting opportunity to find abundant instances of noncompliance and can lead to problems and unnecessary risk.

REGULATORY ABOUT SPREADSHEET​ ​

21 CFR Part 11.10(e)

“spreadsheet applications should be protected with its documentation and security.

ISO 13485 ; Clause 7.5.2.1

“validation of the application of computer software for service provision shall conform to specified requirements”

FDA Laboratory manual of quality procedures Volume III 4.5

“Development and Validation of spreadsheets for collection of data”

OECD No. 17 ; 1.7. Commercial Off-The-Shelf products (COTS)

“If an application (e.g. a spreadsheet) is not complex, it might be sufficient to verify functions against user requirement specifications”

FUNCTIONALITY WE DEVELOPED WITHIN SPREADSHEET