GXP

Spreadsheets and Data Integrity

INTRODUCTION

Spreadsheets used for GMP activities have been one of the major areas of data integrity concerns for many years in the pharmaceutical and biotech industry.

Spreadsheets are widely used in the industry in Quality Control and manufacturing areas.

One of the biggest challenges the industry faced for years is how to validate, maintain, and manage the integrity of data generated using spreadsheets in GMP areas.

Spreadsheets used in GMP areas must be validated and meet data integrity requirements applicable to the industry.

Data integrity of spreadsheets is extremely important because they often generate critical GMP data that have an impact on the product Critical Quality Attributes.

The lack of data integrity in spreadsheets can have a negative impact on the product quality and safety because they are often used to manipulate data generated in the quality control laboratories that is related to testing product quality attributes.

This article will discuss the data integrity challenges with spreadsheets and how to implement a strategy that address current regulatory requirements.

DATA INTEGRITY CHALLENGES WITH SPREADSHEETS

The pharmaceutical and biotechnology industry continues to struggle with understanding how to validate and manage the integrity of data generated by spreadsheets.

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