In an increasingly digital world, Data Integrity (DI) is a top priority for global regulators. ARIREX helps you ensure the accuracy, consistency, and reliability of your data across its entire lifecycle. We address ALCOA+ principles and ensure compliance with 21 CFR Part 11 and EU Annex 11.
Our Computer System Validation (CSV) services ensure that your software and automated systems function correctly and are maintained in a validated state. We bridge the gap between IT, Engineering, and Quality Assurance to deliver practical compliance solutions.
Expert Data Solutions
From gap assessments to remediation programs, we provide the expertise needed to secure your critical GxP data.
- Data Integrity Risk Assessments & Remediation.
- Computer System Validation (CSV) - GAMP 5.
- 21 CFR Part 11 & EU Annex 11 Compliance.
- Data Governance Framework Development.
- Audit Trail Review Strategies.
Trust Your Data
Ensuring data integrity is essential for making informed quality decisions and maintaining product safety.
- Trusted Data: Rely on accurate data for batch release and regulatory reporting.
- Audit Proof Systems: Demonstrate full control and traceability during inspections.
- Reduced Compliance Risk: Mitigate the high risk of data integrity warning letters.