10 Must-Follow Regulatory Compliance Checks for Storing Biological and Cell Therapy Samples in 2025
In the rapidly evolving landscape of cell and gene therapies, maintaining regulatory compliance for biological sample storage isn’t just good practice, it’s essential for patient safety, product integrity, and business continuity. As regulatory frameworks continue to evolve in response to technological advancements and emerging therapies, organizations must stay vigilant about compliance requirements and how to implement a validated storage system. The stakes couldn’t be higher. A single compliance failure can result in compromised patient safety, regulatory actions, financial penalties, and irreparable damage to reputation. For cell therapy CDMOs, biobanks, and other patient-centric organizations, understanding and implementing these critical compliance checks …
Step-by-Step Guide to Implementing Sample Inventory Management System for Managing Biological and Cell Therapy Samples
Across the highly regulated landscape of life sciences, properly managing biological and cell therapy samples isn’t just good practice, it’s essential for regulatory compliance, patient safety, and research integrity. Yet many organizations continue to rely on manual inventory systems that create significant risks and inefficiencies. This comprehensive guide walks through the challenges of manual inventory systems, highlights the key benefits of sample inventory management systems, and offers a clear, actionable 7-phase implementation roadmap. The Limitations of Manual Sample Inventory Traditional inventory management for biological samples typically relies on spreadsheets, paper logs, or basic database systems. These approaches present several critical …
