Biopharmaceutical Analysis eBook
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Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
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BioPharm International’s Biopharmaceutical Analysis eBook
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
This article summarizes a pharmaceutical industry consensus viewpoint of the current regulations regarding data integrity as applied to analytical test data generated to support regulatory activities. In particular, the focus is on data generated by external personnel (e.g., a third-party laboratory or instrument service technician), referred to as vendors.
Analytical instrumentation used in the pharmaceutical industry generates data not only during analytical sample analysis but also during routine or preventive maintenance, such as instrument calibration or qualification, and during troubleshooting associated with repairs. The various scenarios under which outsourced data may be generated and managed are discussed.
Read the article:
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Read the eBook:
BioPharm International’s Biopharmaceutical Analysis eBook