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| Data Integrity App |
MHRA has said, “QA should also review a sample of relevant
audit trails, raw data and metadata as part of self- inspection to ensure
ongoing compliance with the data governance policy/procedures.”
According to PIC/S, “The effectiveness of data integrity
control measures should be assessed periodically as part of self-inspection
(internal audit) or other periodic review processes. This should ensure that controls
over the data life cycle are operating as intended.”
A continuous self-inspection program is an
important element of overall data integrity governance. Aside from the standard
data verification checks built into normal controls, organizations should
incorporate a wider range of measures: training checks, consistency and
risk-based sample checks, and quality metric tracking.
Mock inspection is an essential tool in
identifying issues that could affect the quality of manufactured
pharmaceuticals or medical devices, and become compliance issues with FDA.
Mock inspections are simulations of actual FDA
audits conducted to assess Good Clinical Practice, Good Laboratory Practices,
and Good Manufacturing Practices.
They can be performed by:
• An internal team using FDA procedures, or
• an external team of ex-FDA employees
An internal team consists of qualified
professionals with experience in regulatory compliance. If an external team is
used, it generally consists of members of an outside consulting firm with FDA
work experience.
Mock audits can help pharmaceutical and medical device executives do three things:
1. Determine what FDA inspectors are looking
for during an actual audit
2. Prepare for an actual FDA audit, and
3. Identify common issues of compliance and learn how to rectify them
“Trust but Verify “ Ronald Reagan
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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”
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Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.
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