Blood Bank of Alaska: Streamlining compliance and improving audit readiness

Introduction

Blood Bank of Alaska (BBA), dedicated to providing a safe and adequate blood supply, faced the challenge of maintaining stringent regulatory compliance across all operations. To streamline and improve their quality management processes, BBA turned to Ideagen. 

The challenge

• Ensuring compliance with FDA regulations, AABB standards, and 21 CFR Part 11
• Managing documentation and tracking changes efficiently
• Implementing a robust quality management system (QMS)

The solution

BBA selected Ideagen Quality Management for its:

• Comprehensive quality management capabilities
• User-friendly interface for managing documents and processes
• Real-time visibility and tracking of compliance activities

Implementation and impact

This transition not only ensured adherence to FDA, AABB, and 21 CFR Part 11 regulations but also fostered a culture of continuous improvement and accountability.

With Ideagen, BBA:

• Centralized their document management system
• Improved tracking of changes and compliance activities
• Enhanced overall regulatory compliance and audit readiness
• Achieved compliance with 21 CFR Part 11 requirements