CSA- Same Regulations; Different perspective

Data Integrity App

 

CSA- Same Regulations; Different perspective

A system whose software does not impact Patient Safety, Product Quality is considered Non-GxP, e.g., Systems or Tools used for Document Management, Compliance Management, and Lifecycle Management.

The risk associated with such systems is low, and the same level of rigor on Testing, Documentation is not needed.

GxP systems (Systems having a direct impact) such as LIMS, MES, Adverse event reporting have a higher risk of impacting Patient Safety and Product Quality. Hence such systems require adequate Testing and sufficient documentation.

In a nutshell, the higher the risk, the higher the need for detailed Testing and Documentation.

The below picture depicts how CSV and CSA differentiate from one another without compromising on the regulation requirements.

This is done while keeping in mind the critical aspect  of documentation, which takes a lot of time and effort in a System Validation process for a Life Sciences Company.

To adopt CSA (future of validation?), one needs to conduct a GAP Assessment of the current CSV process within the organization to be able to make the shift from the traditional way of validation.

Many organizations are piloting smaller programs to implement this approach, as it is a cultural shift to make this transition successful However, the most crucial aspect that organizations should not forget is applying critical thinking to make Testing more efficient while maintaining the effectiveness to truly differentiate the traditional way of executing validation using Computer System Validation


“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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