Security of Spread sheet

Data Integrity App

 

Security of Spread sheet

Only the latest validated version of the spreadsheet is being used and to maintain the validated state of the spreadsheet,

All validated Excel spreadsheets should be stored with read-only access rights for the end users (e.g., on a protected network share).

Only responsible persons should have write access to the network share.

End users should have no right to modify a validated spreadsheet, add a non-validated spreadsheet to the share, or save data on the share.

End users should only have the right to fill in the (permitted) cells and to print the data or save a copy to a data repository if needed.

Installation shall be documented, e.g. in the validation file, in a system log book or on a QA form.

The name of the spreadsheet, unique identification, localization, and the person responsible for the spreadsheet shall be documented.

The records shall also include verification, regular verification and other issues such as updates or any problem encountered.

Verification is completed after installation and recorded.

 

Source; Validation of Computerized Systems Annex 1 – Validation of Excel Spreadsheets PA/PH/OMCL (08) 87 R6

 

“Trust but Verify “ Ronald Reagan

 

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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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