How to Implement Data Integrity Controls for SpreadsheetsData

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How to Implement Data Integrity Controls for Spreadsheets

To meet data integrity spreadsheets companies, need to know the population of these electronic tools in their environment. 

Once an inventory is created the next step is to understand the spreadsheets GMP, Part11, and risk level impact.

To understand the impact of spreadsheets companies, need to develop assessment and related procedures that ensure an objective and accurate assessment.

The assessment should include the following:

·         GxP Impact Assessment

·         Part 11 Assessment 

·         Risk Level Assessment


These assessment are an input to the URS document and validation strategy. The URS document must include specific data integrity requirements that must be validated.

Unfortunately, spreadsheet lack data integrity technical controls out of the box. To meet data integrity requirements companies, need to consider additional measures that provide add-ons that enable the following controls:

·         Logical security

·         Audit trails

·         Data protection


Additional technical controls need to be implemented to enable data integrity and this include the following:

·         Periodic backups

·         Securing spreadsheets in secured network drives

·         Protecting cells such that have formulas and calculations

·         Protecting cells that have a data integrity impact


In addition to the examples above companies need to implement procedures controls that ensure spreadsheet data integrity, and these include the following:

·         Audit trails periodic reviews

·         User access periodic reviews

·         Stored data accuracy checks

·         Backup data periodic monitoring

·         Review of all active users

·         Review of access levels for all users

·         Data entry procedure controls


Spreadsheet data integrity controls are critical to ensure alignment with current regulatory requirements, product quality, and patient safety.

Spreadsheet data integrity controls should be implemented based on the risk level and product impact. 


   “Trust but Verify “ Ronald Reagan

 

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