Joseph Mongillo

home / authors / joseph-mongillo

Joseph Mongillo, analytical research and development at Pfizer Inc., Groton, CT

Articles

Risk-based ATR

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

Julie Lippke;Joseph Mongillo;Thomas Cullen;Christian Metz;Katria Harasewych;Fouad Benamira
September 2nd 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 Considerations for Vendor-Generated Data Associated with Analytical Testing

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

Thomas Cullen;Cliff Mitchell;Julie Lippke;Joseph Mongillo;Koottala S. Ramaswamy;Thomas Purdue
August 2nd 2021

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

GORODENKOFF - STOCK.ADOBE.COM

Assessing Data Integrity Risks in an R&D Environment

Julie Lippke;Joseph Mongillo;Thomas Cullen;Chase Waller;Katria Harasewych;Zahid Muhammad;John Bennett
August 2nd 2020

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

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: October 28th 2024 | Updated: November 22nd 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com
Published: November 6th 2024 | Updated: November 22nd 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com
Published: November 5th 2024 | Updated: November 22nd 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com
Published: November 8th 2024 | Updated: November 22nd 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification