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
BioPharm Weekly News Roundup—Week of Oct. 13, 2025
2
Biotech Equipment Market to Approach $144B by 2030: Implications for Pharma R&D
3
Strategies for Building Tech Talent in the Biopharma Industry (Part 4)
4
Why Product-Specific Strategies Matter in Advanced Therapy Manufacturing (Part 3)
5
