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.
Julie Lippke
Advertisement
Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).
Articles by Julie Lippke
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
Advertisement
Latest Updated Articles
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingPublished: July 16th 2021 | Updated:
Assessing Data Integrity Risks in an R&D EnvironmentPublished: October 1st 2020 | Updated:
Advertisement
Advertisement
Trending on BioPharm International
1
Why Flexibility and Commercial Viability Must Be Built-in Early for Scaling CGTs
2
Industry Leaders Detail Transformational Strategies to Mainstream CAR-T Care
3
How Rentschler Biopharma’s New Platforms Aim to Accelerate Biologics Development in Asia
4
Analyzing the Safety and Scope of Next-Generation Gene Editing Platforms
5
