What FDA will expect from your Next Inspection?

 

Data Integrity App


New Approach of Inspection in Pharmaceutical Industry.


“Guilty until proven innocent” approach to auditing!

 

Focus -Potential for fraudulent activity within your quality systems.

 

Assumptions:

•Will assume fraudulent activity is taking place if they identify weaknesses in your quality systems.

•“Data to good to be true!”.

•Electronic data (Meta data) is -preferred choice for regulatory authorities as this is the original (“official”) data.

•Meta data = data about data.

•Meta data is dynamic and can be queried / searched / trended.

•There is a much higher probability of identifying fraudulent activity within an organisation if Meta data is reviewed.

•Hard copy (Flat data –printed, pdf, photocopy) is no longer considered to be acceptable by regulatory authorities as this data is not complete and not original.

•If you state that paper is your original raw data in your internal procedures this will alert an auditor that you are probably not managing and reviewing electronic (meta) data.

 

Data Integrity App

5 key Data Integrity (DI) questions:

•Is electronic data available?

•Is electronic data reviewed?

•Is meta data (audit trails) reviewed regularly?

•Are there clear segregation of duties?

•Has the system been validated for its intended use?

 

The answers to the above questions will determine whether companies are in compliance with 21 CFR part 11 (Electronic records and signatures).

Leave the Original Meta data in the CDS and review / approval electronically to avoid increased Data Integrity risk (the paperless lab).

 

FDA Expectations

FDA conducts inspections to assess compliance with applicable laws and regulations

– Investigators to conduct inspections in a reasonable manner

– Industry to welcome the investigator professionally and do all they can to facilitate an efficient inspection

– For minimal delays to occur at the outset of unannounced inspections; no delays when the inspection was preannounced

– For information to be provided as swiftly as possible without delay; if you don’t know the answer, explain you don’t and get the person who does know as soon as you can

– To be provided with access to all locations and records related to the manufacturing process; which means every step of the way (no “secret” rooms)

– Courtesy and respect shown by all parties

– Investigators to openly communicate the scope of the inspection and findings at least daily

– For contentious issues to arise and for there to be open dialogue; communicate to avoid misunderstanding

– For industry to have procedures for inspections/audits

– For there to be a “war room” 

– For investigators to conduct efficient inspections with as little disruption to operations as possible

 – For copies of records to be provided in a timely manner

– That inspected parties will be nervous (it’s ok, the investigator is too!)


“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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