Excel spreadsheet validation to eliminate 483s

One of the basic issues for organizations in the regulated area is to carry out Excel spreadsheet validation to eliminate 483s.

Why is this so? The FDA requires validation of electronic records, and this is a key requirement. The FDA has its set of regulatory requirements set out in 21 CFR Part 11. This code requires pharmaceutical, biotech, medical device, CRO, life sciences or related FDA-regulated organizations electronic records to be compliant with it. From this, the importance of Excel spreadsheet validation to eliminate 483s can be understood, because configuring an organization’s Excel spreadsheet application is a key requirement.

Making electronic records as genuine as physical records

21 CFR Part 11 is a set of FDA requirements, with which organizations have to comply to demonstrate that the electronic records they use are as good as the same as paper records in terms of genuineness. This is a core requirement for ensuring that electronic records do not get manipulated.

It is to nullify the drawbacks of using electronic records that 21 CFR Part 11 has to be implemented. One of the important aspects of 21 CFR Part 11 is Excel spreadsheet validation. Organizations need to know how to do Excel spreadsheet validation to eliminate 483s. The important benefit of being compliant is that it not only helps organizations avoid 483’s; when done properly, it saves two-thirds of the validation time and costs.

What does it take?

If an organization has to use Excel spreadsheet validation to eliminate 483’s, it needs to:

  • Know what does and does not need to be validated.
  • Know how to configure spreadsheet applications for Part 11 compliance
  • Have an understanding of how to use Excel’s built in 21 CFR Part 11 features for audit trails, security, data verification, and multiple concurrent users
  • Use risk assessment to reduce testing and improve productivity.
  • Specify and test its own GxP Excel application
  • Create a User Requirements document for the application
  • Create a Project Plan document for the application
  • Create a Functional Specifications document for its application
  • Create a Hazard Analysis document for its application
  • Create a Testing Protocol document for your application

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