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PRAKAAR TECH - PHARMA COMPLIANCE
During calibration, the accuracy of a Master Instrument should be
1 day ago | [YT] | 0
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PRAKAAR TECH - PHARMA COMPLIANCE
This channel shares practical GMP and compliance learnings from real cases.
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1 day ago | [YT] | 0
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PRAKAAR TECH - PHARMA COMPLIANCE
GAMP 5 isn’t just a validation guideline—it’s a way of thinking. It recognizes that not all software deserves the same level of trust or control, so it applies human judgment and risk awareness to computerized systems that impact patient safety and product quality. An Excel sheet used for scheduling training doesn’t need the same scrutiny as an MES controlling tablet compression or a custom algorithm calculating drug dosage. GAMP 5 says: validate what matters most, don’t over-engineer what doesn’t, and always focus on risk to the patient. It bridges the gap between blind compliance and blind trust, turning validation from paperwork into a meaningful, risk-based assurance that technology is truly fit for its intended use.
#GAMP5 #CSV #PharmaQuality #DataIntegrity #Validation #GxP #QualityMindset
2 weeks ago | [YT] | 4
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PRAKAAR TECH - PHARMA COMPLIANCE
Most people think CSV is only for GMP.
But CSV is actually about trusting your data and decisions — regulated or not.
3 weeks ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
What is the main purpose of CSV beyond GMP?
3 weeks ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
Which non-GMP system needs validation the most?
3 weeks ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
Why do companies apply CSV in non-GMP systems?
3 weeks ago | [YT] | 1
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PRAKAAR TECH - PHARMA COMPLIANCE
Where do you think Computerized System Validation (CSV) is required?
3 weeks ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
Open System – 21 CFR Part 11
A system where system access is not controlled by the record owner and data is stored or accessed outside the plant network.
Examples:
Calibration management software maintained on vendor servers
Finished goods testing data generated by CRO / CDMO
Both are Open Systems under 21 CFR Part 11.
1 month ago | [YT] | 0
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PRAKAAR TECH - PHARMA COMPLIANCE
In Computerised System Validation, which document defines how the system will be tested to verify that it meets user requirements?
#CSV #PharmaCompliance #PrakaarTech
3 months ago | [YT] | 2
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