Spreadsheet Inventory Review

Data Integrity App

 

Spreadsheet Inventory Review

Inventory should be reviewed with the goal of minimizing the workload and simplifying the inventory.

Often the spreadsheet inventory will include ‘populated’ spreadsheets (i.e. “.XLS” files) containing data and it is strongly recommended that these are NOT subjected to validation in their native format.

In order to facilitate validation, it is preferable to install controlled and ‘empty’ spreadsheet templates (i.e. “.XLT” files); hence some reformatting / data cleaning will be necessary prior to validation.

This reformatting step is an opportunity to review and rationalize the spreadsheets that are going to be subject to validation.


An inventory review should be performed with the following questions in mind:

• Are there any new requirements for existing spreadsheets?

• Can any spreadsheets be combined to produce a single template?

• Can spreadsheets be ‘genericised’ to allow future flexibility?


The combination/genericization steps are crucial to reducing the validation workload; the following are examples of how this can be achieved:

• Use multiple worksheets in a single template.

• Make column headings data input areas.

• Add extra input areas to a worksheet to allow it to be used for multiple purposes.

• Add configuration sheets/tables and lookup cells to allow future modifications with minimal/no revalidation effort.

 

“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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