PRAKAAR TECH - PHARMA COMPLIANCE
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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 week 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
2 months ago | [YT] | 2
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PRAKAAR TECH - PHARMA COMPLIANCE
Which aspect do you think is the biggest challenge in Computerized System Validation ?
3 months ago | [YT] | 1
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PRAKAAR TECH - PHARMA COMPLIANCE
What is the main purpose of Computer System Validation?
3 months ago | [YT] | 1
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