Implementation: Data Integration

The INTERCEPT Data Management System (IDMS)
The INTERCEPT Data Management System (IDMS) is a software tool designed to facilitate efficient and correct processing of INTERCEPT Platelets and Plasma. This system electronically documents successful completion of the critical steps during manufacturing and allows the customer to identify the instantaneous status of any blood unit being processed.

Adaptable to customer needs

• Optional barcode and step verifications
• Process can be adapted to different types of products
• Assists with GMP compliance

Ensures compliant operations

• Keeps records of processes, operator’s and other vital data required by blood centers
• Assists with electronic record keeping regulations

Easy to install and operate

• User interface through Microsoft Internet Explorer
• Standard database software
• Data input via keyboard and barcode scanner
• Flexible for many European languages

Step by step documentation: Operators access the system with a secure password and use a graphical user interface and barcode scanners to input the current manufacturing status of platelet and plasma units throughout the pathogen inactivation process. Upon successful completion of all processing steps, the unit is designated as "pathogen inactivated" in the IDMS database. Should a unit fail to meet specifications during processing, it is recorded as an incomplete product.

Benefits
The software was designed by blood centers for blood centers. The benefits of the IDMS include:

Helps blood centers conform to GMP practices

• Provides an electronic GMP record for the pathogen inactivation process

Verifies acceptable product characteristics to reduce processing errors and product loss

• Volume
• Platelet Count
• Red Cell Count

Safeguards against operator error

• Helps prevent accidental use of inappropriate disposable treatment sets
• Warns users if attempting to process products not meeting acceptance criteria

Prevents unnecessary waste

• Centralized data repository for processing times
• System alarm ensures illumination within the specified processing time
• Prompts operator to stay within 4 to 16 hour CAD incubation time for platelets
• Highlights products approaching established time limits