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Downstream Processing|

Upstream Processing

Julie Lippke

Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).

Articles by Julie Lippke

Audits and inspections

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

ByJulie Lippke,Joseph Mongillo,Thomas Cullen,Christian Metz,Katria Harasewych ,Fouad Benamira

November 15th 2022

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

Data Integrity Associated with Analytical Testing

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

ByThomas Cullen,Cliff Mitchell,Julie Lippke,Joseph Mongillo,Koottala S. Ramaswamy,Thomas Purdue

July 15th 2021

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

Assessing Data Integrity Risks in an R&D Environment

ByJulie Lippke,Joseph Mongillo,Thomas Cullen,Chase Waller,Katria Harasewych ,Zahid Muhammad,John Bennett

October 1st 2020

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.

Latest Updated Articles

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
July 15th 2021
Assessing Data Integrity Risks in an R&D Environment
October 1st 2020