Excel Spreadsheet Validation for FDA 21 CFR Part 11

Given the ease of their operations; spreadsheets find wide acceptance in a number of activities for laboratories. These include analysis, data capturing and reporting. Since these activities are part of a regulatory framework; companies using these spreadsheets need to comply with guidelines. These guidelines are set out in FDA 21 CFR Part 11, which deals with regulation of electronic records and electronic signatures. In this guideline, there are specific points about the use of spreadsheets.

More about Part 11

Part 11 applies to the following:

For spreadsheets that contain records required by the underlying predicate rules such as 21 CFR Parts 210 and 211 (cGMP), Part 820 (QSR) or Part 58 (GLP)

For spreadsheets that have records that are created, modified, maintained, archived, retrieved or transmitted in electronic form, or those that are submitted to FDA in electronic form.

What are FDA 21 CFR Part 11 compliance requirements?

21 CFR Part 11 makes it clear that an electronic spreadsheet has to meet the following requirements if it has to be compliant:

Security: The aim of setting out security requirements is predictable –to prevent unauthorized access to records. It seeks to make the records safe from unauthorized entry and access for the entire duration of the record’s shelf life. It sets out clear rules for user management functions.

Audit trails: Section 21 CFR 11.10(e) sets out the rules under which systems subject to Part 11 must employ audit trails. The aim of this rule is to ensure that audit trails should automatically record the date and time of all entries. These could be actions pertaining to any of these: creation, modification or deletion of electronic records. An important requirement is that record changes should “not obscure previously recorded information”. To ensure this, an audit trail for spreadsheets should include a timestamp, worksheet name, cell address, action performed, old value, new value, user ID, user name and reason for change, if applicable. It is important to note that the audit trail should not be modifiable even by the system administrator.

Electronic signatures: To ensure authentication of electronic signatures, 21 CFR Part 11 covers compliance regulations for three aspects: the printed name of the signer, the time and date on which the signature was done, and finally, the purpose of the signature. Under the last of these, the signer is expected to mention whether the sign was of review, authorship, approval, or for assigning a responsibility to someone else.

References:

http://us.mt.com/mt_ext_files/Editorial/Generic/8/2-2005_LabMagazine_Editorial-Generic_1131619850993_files/ENLabMag_2_05_8.pdf

 

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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