Does the spreadsheet need to be validated?
Data Integrity App |
Does the spreadsheet need to be validated?
One of the first
things that need to be determined is whether or not the spreadsheet needs
validating.
These principal
questions should address whether the spreadsheet is used to support an activity
governed by any applicable regulation, typically GMP’s1,2, GLP’s3,4, ERES5,
Medical Devices6 etc.
If the answer is
Yes, then the simple answer is that it should be validated.
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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.
- 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”
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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