Data Integrity Requirements Applicable to Spreadsheets

Data Integrity App

 

Spreadsheets used in GMP operations must meet data integrity requirements including the principles from ALCOA which requires data to meet the following criteria:

·         Attributable

·         Legible

·         Contemporaneous

·         Original 

·         Accurate

Attributable spreadsheet data must be linked to the individual who created the data.

Legible spreadsheet data is clear, concise, and readable. Changes to legible data must not hide or obscure the original record.

Contemporaneous spreadsheet data is recorded at the time the work is performed. 

Original spreadsheet data include the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity

Accurate spreadsheet data is correct, truthful, complete, valid and reliable.

Spreadsheet data integrity refers to the accuracy and consistency of data, indicated by an absence of any alteration in data between two updates of a data record. 

Current regulatory requirements related to data integrity are applicable to spreadsheets used in GMP operations.

These spreadsheet data integrity requirements include the following examples:

·         System security

·         Traceability of all transactions

·         Record retention

·         Data protection

Spreadsheet data integrity requirements are similar those applicable to electronic systems. To meet data integrity requirements spreadsheets, need technical and procedure controls that enable alignment and compliance with current regulatory expectations. 

“Trust but Verify “ Ronald Reagan

 

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If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App


 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


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