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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.
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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
– 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.
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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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