Spreadsheets Vs. Sample Inventory Management Systems: A Comparative Guide for Managing Biological and Cell Therapy Sample Data
In the highly regulated world of life sciences and cell therapy, proper inventory management of biological samples isn’t just good practice it’s critical for patient safety, regulatory compliance, and operational success. Organizations working with biological materials face unique challenges that demand robust solutions beyond what conventional tracking methods can offer. This guide provides a thorough comparison between traditional spreadsheet-based inventory management and specialized sample storage inventory systems designed specifically for GMP-regulated environments. Understanding these differences is crucial for organizations seeking to enhance their sample management processes while maintaining FDA compliance. The Current Landscape of Sample Management in Life Sciences Many …
How a Sample Inventory Management System Supports Scaling from Phase I to Commercialization
In the world of cell and gene therapy, growth is both the goal and the challenge. Early-stage biotech companies begin with a handful of samples, managed in spreadsheets and tracked manually. But what happens when your promising therapy enters Phase II, scales to multi-site trials, and eventually moves toward commercialization? The complexity of managing biological and cell therapy samples grows exponentially, and manual processes simply can’t keep up. This is where a scalable sample inventory system, implemented step by step becomes essential for managing biological and cell therapy samples. In this use case deep dive, we explore how the right …
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 …
CASE STUDY : Partnering with NYBC to Transform Their Cord Blood Storage and Distribution
A case study demonstrating how Pragmatrix’s GMP-compliant sample inventory management solutions helped the New York Blood Center (NYBC) optimize their cord blood storage and distribution while maintaining strict FDA regulatory compliance Building the Infrastructure for NYBC’s Life-Saving Cord Blood Program For over five decades, the New York Blood Center (NYBC) has played a critical role in healthcare across New York and New Jersey. As a non-profit organization committed to public health, NYBC delivers essential blood products, transfusion services, and public health research to support a population of over 20 million people. Central to this mission is the National Cord Blood …
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 …
Implementing Barcodes in GMP Biologics: Overcoming Challenges & Choosing the Right Software
The implementation of barcodes in GMP (Good Manufacturing Practice) environments for patient-centric biologics handling firms can seem daunting. While the benefits are undeniable, the transition often presents challenges. Let’s delve into the practical difficulties and how the right software can ease this process. Challenges of Barcode Implementation in GMP Biologics Complex Workflows: Biologic manufacturing processes are often intricate, involving multiple stages and numerous materials. Mapping these workflows into a barcode system can be complex and time-consuming. Data Integrity Concerns: Ensuring accurate data capture and preventing errors is crucial in GMP environments. Barcode systems must be reliable and robust to maintain …
Streamlining COI and COC for GMP Organizations: A Practical Guide to Software Implementation
Ensuring a seamless Chain of Identity (COI) and Chain of Custody (COC) is a top priority for GMP (Good Manufacturing Practice) organizations. While the transition to digital systems offers immense benefits, a successful implementation requires careful planning and collaboration. This guide outlines key steps to navigate this process smoothly. I. Selecting the Right Software Vendor: Prioritize Your Needs Understand Your Unique Workflow: Map out your existing processes, identifying pain points and areas where software can add value. Define Requirements: Create a detailed list of features that align with your organization’s specific needs. This should include everything from COI/COC tracking to …
Beyond Paper: Unlocking the Power of Electronic SOPs for GMP Compliance
In the highly regulated world of Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs) are the backbone of quality and compliance. Traditionally, these SOPs have existed in the physical realm of binders and paper documents. However, as technology advances, the question arises: Is it necessary for GMP companies to transition from paper-based SOPs to software solutions? The Pros and Cons of Software for SOPs Let’s delve into the advantages and disadvantages of implementing software for SOP management in GMP environments: PROS Enhanced Accessibility: Digital SOPs can be accessed from anywhere, anytime, on various devices, improving efficiency and collaboration. Version Control …
Off-the-Shelf Software for Cell Therapy Supply Chain and Manufacturing: A Reality Check
Cell therapy is a rapidly evolving field with unique complexities in its supply chain and manufacturing processes. As CMOs (Contract Manufacturing Organizations) and CDMOs (Contract Development and Manufacturing Organizations) look for solutions to streamline their operations and ensure compliance, the question arises: Is there an off-the-shelf software system that can cater to their specific needs? The Current Landscape While there are several software solutions available that address certain aspects of the cell therapy supply chain and manufacturing, a truly comprehensive, off-the-shelf system remains elusive. This is due to several factors: Unique Workflows: Each cell therapy product has its own unique …
Chain of Identity (COI) & Chain of Custody (COC) in Biologics: A Deep Dive
In the intricate world of biologics, where patient safety is paramount, two concepts stand out as critical pillars of quality assurance: Chain of Identity (COI) and Chain of Custody (COC). Let’s explore what they mean and why they are indispensable for patient-centric organizations. What are COI and COC? Chain of Identity (COI): Think of COI as the birth certificate and lifelong identification of a biologic product. It tracks the unique characteristics and identifiers of a product from its inception (raw materials) through every stage of production, testing, and distribution. Chain of Custody (COC): This is the product’s travel journal. It …
