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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3 thoughts on “Excel spreadsheet validation to eliminate 483s

  1. Hello,

    Can you tell me please how frequently to validate my Excel sheets in a GLP lab.Can you suggest any criteria.

    Regards
    Raghul J

    • Hi Raghul Jayaprakash,
      One criteria of procedure is there for validate Excel sheets. Please go through as below.

      Validation procedure. The validation procedure should include detailed steps
      on how to conduct the validation. It should describe the computer system
      configuration, as well as test methods and objective acceptance criteria, including
      expected outcomes. The procedures should be reviewed and approved by designated
      management. The validation procedure should be divided into an Installation
      Qualification (IQ) and Performance Qualification (PQ).
      9 Installation Qualification. The test cases in the IQ will establish confidence that
      the computer hardware and spreadsheet software is in compliance with the
      manufacturer and the specifications. The following test cases in the IQ for the
      spreadsheet applications software, workbook files and formulas include (4):
      ƒ System documentation.
      ƒ Computer system configuration verification.
      ƒ List of communication cables.
      ƒ Verification of electrical utility.
      ƒ Hardware maintenance contracts/procedures.
      ƒ Hardware change control.
      ƒ List of critical equipment and spare parts.
      ƒ Software review.
      ƒ Software change control.
      ƒ Standard operating procedure review.
      ƒ Personnel training requirements and records
      ƒ System security-physical access.
      ƒ System security-on line program access.
      ƒ Software formulas.
      DFS/ORA Laboratory Information Bulletin No. 4317
      Software Validation
      Page 15 of 40
      ƒ Printer generated data.
      ƒ Programmable functional keys (PFKs) and Displays verification.
      ƒ Environmental conditions.
      Performance Qualification. PQ will thoroughly, rigorously and consistently
      challenge the software by testing all input/output values, data structure, process
      variables, and control flow logic. The following test cases in the PQ on
      spreadsheet applications include (4):
      ƒ On-Line Program Access Verification.
      ƒ Field specification verification.
      ƒ Power failure checkout.
      ƒ PFKs verification.
      ƒ Communication failures.
      ƒ Electromagnetic interference (EMI) / radio frequency interference (RFI)
      verification.
      ƒ Field specification verification.
      ƒ Printout reports.
      ƒ Performance testing.
      Validation report . The validation report should document detailed results of the
      validation effort, including test results. Whenever possible, test results should be
      expressed in quantified terms rather than stated as “pass/fail”. The report should be
      reviewed and approved by designated management.

      For More Info: http://bit.ly/ExcelSpreadsheetValidation

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