How to Identify Spreadsheets That Must Meet Data Integrity Requirements

Data Integrity App

 How to Identify Spreadsheets That Must Meet Data Integrity Requirements

One of the biggest challenges normally faced by the industry is not knowing the population of spreadsheets at their facilities. Normally lack an accurate inventory of spreadsheet that may be used for GMP operations that must meet data integrity requirements.

The lack of validation is another challenge for spreadsheets that are not identified as having GMP impact. Spreadsheets that are not validated lack procedure and technical controls that enable data integrity.

Identifying spreadsheets that may have GMP impact is a critical activity to ensure compliance with data integrity and regulatory requirements.

To identify spreadsheets that may have GMP impact companies need to initiate a remediation project for these electronic tools.

A remediation plan should be created to define the activities, roles, responsibilities and overall strategy to identify, validate and enable data integrity for spreadsheets that may have GMP impact.

The remediation plan should include creating an inventory of spreadsheets used by the corporate and site teams.

The inventory should include all departments that engage in GMP activities and must include manufacturing, quality control and quality assurance which are departments that normally have spreadsheets that are not validated and don’t meet data integrity requirements


 “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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