HemaCare’s Improved Business Productivity
Freezerworks replaced HemaCare’s paper-and-spreadsheet inventory system with a fully traceable relational database, achieving a >98% traceability success rate within six months and enabling real-time sales visibility across all blood product lines.
“For HemaCare, it’s important to have a system flexible enough that we could adapt it on demand to meet the requirements of our business.”
ABOUT HEMACARE
Built on a 37-year history in apheresis collection, HemaCare Bioresearch Products and Services is a trusted research partner and leader in human primary cell and tissue collection, processing, and cell therapy. Located in Van Nuys, California, HemaCare provides high-quality biological material derived from normal and mobilized peripheral blood, bone marrow, and cord blood.
As biomedical companies adapt to meet growing customer needs in a heavily regulated environment, powerful yet configurable software is essential. Today, Freezerworks plays an important role in managing the movement of HemaCare’s blood products, from production and storage through sale and shipment, in a global market.
Note: HemaCare is now part of Charles River Laboratories (www.criver.com/hemacare)
THE SITUATION
As HemaCare expanded its cryopreserved blood product line, including mononuclear cells and stem cells, its manual inventory systems could no longer keep pace. Christine Lee, Manager of Regulatory Affairs and Quality Assurance, describes the journey:
"We had a paper system, but it became cumbersome and lacked efficiency for our growing business," Lee recalled. Early records could not support the traceability needed for regulated blood product workflows.
While spreadsheets improved on paper, they couldn’t link samples to aliquots to transactions, a critical need for regulated blood products moving through quarantine, testing, and release.
Prior to the new system, the sales staff had to wait to get information on available products, delaying customer responses and creating competitive disadvantages in a fast-moving market.
Blood products must pass through a validated process of testing and approval before moving from production to quarantine to release for sale, demanding audit trails, chain-of-custody tracking, and QA-defensible data integrity.
OUR SOLUTIONS
Relational Database Configuration & Training
Christine Lee attended a three-day strong Freezerworks Training Camp, then independently configured the entire system to match HemaCare’s operational workflow, No IT programmer required. Each Sample record was structured to represent one human donor, giving end users a clean, single-view record of all donor characteristics.
- Sample records designed so each represents one human donor with all key characteristics visible at a glance
- Aliquot entry page configured to assign freezer locations and track product availability in real time
- Full configuration completed within a six-month timeframe by QA staff
Lee’s QA background proved critical: she understood what information was required for accuracy, traceability, and audit defensibility, and built that directly into the configuration.
Data Standardization & Chain of Custody
Rules-based field relationships were built directly into the system. Selecting a product category automatically populates associated fields, while color-coded Lot Status indicators give every user an instant visual read of inventory state.
- Auto-populated fields eliminate manual entry errors and enforce data integrity across Production and QA
- Color-coded Lot Status: Green = Released for sale, Red = Quarantined; visible at a glance on every aliquot
- Check Out/Check In feature locks quarantined aliquots from accidental sale until QA approval
- Every entry, modification, and deletion is automatically recorded in a protected, tamper-evident audit trail
"When I designed all these fields, I recognized what information was required for accuracy and traceability. If I'm going to perform an audit, I'm expecting a user to be able to show me from creation to distribution where a vial is throughout the process." — Christine Lee
THE OUTCOMES
By replacing paper logs and spreadsheets with a fully configured Freezerworks system, HemaCare achieved measurable improvements in traceability, productivity, and scalability, all validated by their own QA manager.
>98% Traceability
Internal audit confirmed >98% traceability success rate within six months of implementation.
Real-Time Sales Visibility
Sales staff gained instant access to inventory volume and donor variety, enabling just-in-time ordering.
Audit-Ready Chain of Custody
Every vial traceable from creation to distribution with a protected, tamper-evident audit trail.
One Platform, Multiple Use Cases
Same Freezerworks system extended to manage special collections and cell therapy clinical trials.
