|Articles|July 16, 2021

BioPharm International

  • BioPharm International, 2021 Biopharmaceutical Analysis eBook
  • Volume 2021 eBook
  • Issue 3

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

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.

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