Checklist of pharma inspection

Data Integrity App

 

Introduction 

Check list play vital role in preparation of any inspection. Proper check list will minimize chances of mistake. Prepare proper check list for better inspection.

“Failing to prepare is preparing to Fail”

Refer below points while preparing checklist

• Review of existing Software Validation Lifecycle policies, SOPs, etc.
• Identification of paper data, electronic data, raw data, and static and dynamic data
• Intended use of computer systems (e.g., SOPs, workflows, etc.)
• Use of notebooks and forms associated with computer systems
• System security and access to data (e.g., user types, groups, roles, accounts, etc.)
• Electronic signatures and audit trails
• Data retention policies and availability of data
• Data backup, archive, restore and recovery processes
• Training for support and use computer systems that collect, generate, store, analyze, and/or report regulated data

“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.