GXP

Substandard Data and Documentation Practices—Case Study #9 | IVT

Test data and results generated as specified in the validation protocol are critical in the validation process because they provide the basis for the final validation report. Data recording and associated documentation for validation may not meet expected quality standards. Several actual examples involving problems with data and documentation associated with validation are described. These include data recording on scrap paper, erroneous transcribed data, improper error corrections, data inconsistent with protocols, and other examples. Major data and documentation problems may be categorized...

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