AI meets gxp: model cards for trust, transparency and compliance
Artificial intelligence is shaking up the pharmaceutical industry, delivering efficiencies in...
Ensuring Data Integrity for Statistical Software in GxP Environments: Top 10 Audit Requests
The life sciences industry relies on statistical programming software companies like SAS and...
2024 Top Data Integrity Audit Issues
In the fast-evolving world of life sciences, ensuring the integrity of GMP records has never been...
Top 10 Data Integrity Requests During a Life Sciences Audit
In today’s life sciences industry, ensuring data integrity is crucial to maintaining regulatory...
GxP Compliant Data Migration: Assuring Data Integrity with Zero-Acceptance Sampling
Migrating GxP-compliant data between digital systems can feel like stepping into a minefield. For...
Data Integrity: Ensuring Consistency Amidst Technological Advancement
Back in June 2021, we emphasized that data integrity is a shared responsibility. The article...
The Importance of a GxP Computerized Systems Inventory in Life Sciences
In life sciences, compliance isn’t just about following rules—it’s about safeguarding patient...
Navigating Digital Transformation, while assuring GxP Compliance
For clinical-stage life sciences companies, the transition to digital systems is critical for...
Data Integrity - To Infinity and Beyond, starting 2023!
Having just welcomed 2023 and watched way too many animated movies (including a household...
Original GxP Record, The O in ALCOA+
Understanding what constitutes an original record and applying data management...