Data integrity has become one of the top concerns for health authorities globally. USFDA, MHRA, and WHO have all issued guidance on data integrity, and failures in this area have resulted in import alerts, consent decrees, and facility shutdowns. RBridge Lifesciences provides thorough data integrity audits to identify vulnerabilities before regulators do.
What We Offer
- Data Integrity Gap Assessment against ALCOA+ principles
- Laboratory Data Integrity Review (Instrumental and Chemical Analysis)
- Electronic System Audit Trails Review
- Hard Copy and Soft Copy Data Review for Release and Stability Testing
- Data Integrity Remediation Planning
- Training on Data Integrity Requirements
ALCOA+ Framework
- Attributable – data must be traceable to the person or system that generated it
- Legible – records must be readable and permanently retained
- Contemporaneous – data must be recorded at the time of the activity
- Original – the first capture of data must be preserved
- Accurate – data must reflect the actual result obtained
- Plus: Complete, Consistent, Enduring, and Available