It is important for organizations to validate their own Excel Spreadsheet Application

[John Robinson]

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Organizations that validate their Excel spreadsheet applications stay compliant with FDA requirements,avoid 483’s and save two-thirds of the cost and time on validation.

A critical requirement from the FDA is validation of electronic records. These electronic records have to be compliant with the set of FDA Code of Federal Regulations, the 21 CFR Part 11.

The industries in which this is needed are the following:

• Pharmaceutical
• Biotech
• Medical device
• CRO
• Life sciences or related FDA-regulated organizations

Being knowledgeable about configuring an organization’s Excel spreadsheet application becomes a key requirement for organizations to not only meet FDA requirements, but avoid 483’s as well.

A word about 21 CFR Part 11

Complying with 21 CFR Part 11 is a quintessential part of validation of Excel spreadsheet application. 21 CFR Part 11 is a set of FDA requirements. The FDA requires compliance with this Part if the kinds of organizations shown above are to be considered as being compliant with their electronic records. These electronic records could be used for a variety of purposes, and hence their genuineness and authenticity is very crucial to ensure that they are the same as paper records.

Validation of Excel spreadsheet application is important because electronic records are prone to various kinds of manipulation. Staying compliant with 21 CFR Part 11 is what validation of Excel spreadsheets essentially means.

Since globally, organizations are graduating to electronic records and phasing paper records out; implementation of electronic records is inevitable. The long-term impact of paper records and the speed of communication make this even more so. It is estimated that when organizations validate Excel spreadsheet applications using appropriate and well-designed validation templates; they save up to two-thirds of the validation time and costs.

What does compliance entail?

The first step to this is configuring the organization’s Excel spreadsheet application as prescribed by the FDA. A risk-based validation approach is the right step, as it reduces and can even eliminate risks.

Coming to the validation of Excel spreadsheet applications, the organization should devise a methodology by which it creates these kinds of documentation into their Excel application:

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