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...
ERA Sciences @ ISPE GAMP Event 26th September
Join us at the latest ISPE event to discuss GMP digital solutions and future technologies in the...
ERA Sciences @ Interphex 16th April
If you're attending Interphex this year come see our talk "Optimizing for Failure - Survivorship...
ICH Q9 R1 - the highlights
Hurray! We applaud the new release of guidance around risk management to...
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...
The Art of 'Exception'
When ERA Sciences advise on test exception management for protocol execution issues,...