Introduction of Spreadsheet

Data Integrity App

 

Spreadsheets are widely used in the industry in Quality Control and manufacturing areas

Many GxP critical spreadsheets need to undergo validation to ensure that the data they generate is accurate and secure.

One of the biggest challenges the industry faced for years is how to validate, maintain, and manage the integrity of data generated using spreadsheets in GMP areas.

Spreadsheets used in GMP areas must be validated and meet data integrity requirements applicable to the industry.

Data integrity of spreadsheets is extremely important because they often generate critical GMP data that have an impact on the product Critical Quality Attributes.

The lack of data integrity in spreadsheets can have a negative impact on the product quality and safety because they are often used to manipulate data generated in the quality control laboratories that is related to testing product quality attributes.

Here we describe a pragmatic approach to the validation of Excel spreadsheets using the principals of GAMP 4.

The validation lifecycle requirements are met using a generic documentation set which allows spreadsheet validation and implementation with two documented deliverables.

Compliance with the user’s applicable regulations is achievable using this flexible and cost effective process.

It is recognized that Excel Spreadsheets have been widely used in all industries for many years. A major attraction of spreadsheets is their ease of use and flexibility – anybody with a minimum amount of training/experience can create and modify spreadsheets.

The downside of this versatility is the potential for developer and operator error, and the difficulty in verification of the spreadsheet and the data it produces.

Additionally there are inherent security and audit trail deficiencies in the standard MS-Excel product, leading many experts to consider spreadsheets as ‘unvalidatable’.

These factors have led auditors to consider spreadsheets as a common system in which data can be incorrectly calculated and reported, both due to accidental, and intentional operator actions.

 

 

 “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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