QuantityĬombined IQ-OQ-PQ Computer (Issue-4) $159.00 This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template. From the results of this exercise the scope of all validation activity can and must be justified. You have also considered various aspects of its use and the implications of any malfunctions. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. Validation Risk Assessment (Issue 11) $125.00
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