Do’s and Don’ts for being inspections prepared

 

Data Integrity App

Do’s and Don’ts During inspection

Do’s:

 • Answer all questions honestly;

• Say “I don’t know” or “I’ll get the answer for you;”

• Avoid such phrases as “I think,” “Sometimes/often/usually,” “never” and “next time;”

• Avoid qualifiers, such as “typically,” “normally,” “generally” and “usually;”

• Stop speaking once the question is answered;

 • Ask for explanations or interpretations of what you do not understand;

• Maintain a friendly and cooperative attitude;

• Control your temper; remain courteous & professional

• Maintain eye contact.

 

 

Don’t:

 • Volunteer information or answer a question that hasn’t been asked;

• Be sarcastic;

• Guess answers;

• Attempt to answer “what if?” or hypothetical questions;

• Argue with an investigator;

 • Philosophize, ramble or editorialize;

• Point out deficiencies or errors;

• Apologize for problems or comments made by an investigator;

• Feel the need to respond to every comment made;

• Become defensive or evasive;

• Look away, fidget or look nervous; or

• Make statements about your personal opinion of the FDA.

“Trust but Verify “ Ronald Reagan

 

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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.