EndoScan-V™ EndoScan-V™ v6 Features • Validated on Microsoft® Windows® 7 and 10 operating systems • Utilizes database function with PostGres database • Sample and accessory databases • Enhanced user management • Intuitive drag and drop functionality for easy template setup • Facilitates 21 CFR Part 11 and data integrity compliance • Fully searchable audit trail • Enhanced tracking and trending integration via Charles River Cortex™ • Validation, installation, operation, and performance qualification packages available Data-driven decisions are the only way to confidently confirm product quality and ensure patient safety. With over 70 million LAL tests being performed every year, it is now a requirement to ensure that electronic data generation is secure and reliable. Your endotoxin detection platform requires software that generates accurate raw data analysis for reporting, tracking, and trending. Accurate and timely results are critical to ensuring your laboratory and manufacturing processes stay in a state of constant control. EndoScan-V™ is a validated endotoxin detection and measuring software used to generate and report quantitative LAL test data. The program performs the requisite calculations and creates batch reports for product release. For added protection, it generates secure data and audit trails on all actions. The program was designed with flexible capabilities and performance options for gaining operational efficiencies. All aspects of the software form the pillars of data integrity compliance: fully searchable audit trail, flexible user control and management, and reliable data generation and backup. How confident are you in the accuracy and security of your release testing data? Fundamental Elements for Data Integrity Compliance User Management: All settings and actions in the software are attributed to a privilege. Privilege groups can be established so flexibility within user access to any part of the software can be as restrictive or open as needed. Controlling user access to how data is generated and stored is critical for confirming data integrity. For additional security each user requires a username and password. EndoScan-V™ includes an automatic lock function when no activity occurs for a specified time while the test continues to run in the background. • Available in English, French, German, Spanish, Italian, and Brazilian Portuguese

Searchable Audit Trail: Allows the user to search using open keyword or pre-defined searches for critical actions. The ability to switch on comments for Post Assay changes, Global Settings changes, and Digital Signature changes allows the company to capture the Why to the Who, What, and When of an audit trail. This enables a reconstruction of all events if necessary. Audit trail searches can be printed and manually signed. The ability to reconstruct critical elements of data generation gives firms more insight into the investigative process during unexpected events and ultimately ensures compliance...

PC System Requirements PC System Requirements PC which meets all minimum requirements for the Windows 7 operating system or Windows 10 system. Minimum hardware configuration: • Intel Core i3 - 2.5 gigahertz (GHz) or faster • 64-bit architecture • 4 gigabyte (GB) RAM Recommended hardware configuration: • Intel Core i5 2.0 (GHz) or faster • 64-bit architecture • 8 gigabyte (GB) RAM Hard drive minimum requirements: • Minimum hard drive space for EndoScan-V™Client installation – 200 MB • Minimum hard drive space for EndoScan-V™Services installation – 50 MB Minimum hard drive space for Microbial Solutions...

EndoScan-V™ Product Codes Product EndoScan-V™ 6.0 Client Manager Software Validation Charles River’s Bacterial Endotoxin Testing Software Portfolio Charles River’s bacterial endotoxin detection and measuring software is designed specifically to help reduce variability and increase operational efficiencies by achieving quantitative results and incorporating flexible configuration capabilities. While EndoScan-V™ will provide you with real-time, secure, and reliable endotoxin test data, Charles River Cortex™ can provide an integrated solution to securely consolidate, query, and analyze that data...