Spreadsheet reformatting

Data Integrity App

 

Spreadsheet reformatting

Design, development and reformatting of the spreadsheets should be performed with a view to facilitating validation.

If spreadsheet reformatting is to be performed repeatedly in house, it is preferable to have predefined design guidelines User Acceptance Prototyping, Design/Build Live Operation, URS, FS, Single Spreadsheet Specification Document, Test Installation, OQ/PQ, Single Spreadsheet Qualification Document, IQ & Functional Testing Amended V model for Excel Spreadsheet validation and standards.


When the work is contracted out then the design standards should be agreed in advance, typical guidelines to be followed include:

• Workbooks should have an ‘intuitive’ lay-out with discrete/manageable sections, for example separate areas for data input and results

• Where possible lookups should be used to “pull” data from other locations and worksheets rather than having repeated data input areas.

• Macro use should be kept to a minimum, especially if they are not critical to the accurate or efficient use of the spreadsheets. Macros can save time when in use, but will bring an additional burden for validation.

• Incorporate any add-in modules such as electronic signatures and audit trail modules, so that they can be validated as generic systems/modules, and then do not require full validation on every spreadsheet.

• There should be a consistent ‘look and feel’ to all spreadsheets, e.g. colors for input cells, consistent use of comments and cell validation etc. This will assist in user training and acceptance, and aid the implementation of a single spreadsheet operation SOP

 


“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

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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