Leading Biopharmaceutical Company Selects Infolinx® WEB
Expanded Security Functionality to meet Compliancy Requirements
Oncology-focused subsidiary of Japan's largest pharmaceutical company based in Cambridge, MA has selected Infolinx® WEB for the enterprise management of physical records. Aspiring to find a cure for cancer, this fully integrated biopharmaceutical will be leveraging the extensive application and security configuration capabilities of Infolinx WEB to manage the entire lifecycle of paper-based records for multiple departments including legal, quality assurance, non-communicable diseases, clinical development, environmental health and safety, computer and laboratory systems, and facilities.
Modeled after 21 CFR Part 11 requirements and boasting an advanced configurable security model along with extensive records retention and legal holds support, version 3.2 of Infolinx WEB enables regulatory compliance for clients within the highly regulated and competitive pharmaceutical industry.
"Application functionality including multiple token controlled access, configurable data access restrictions, complete audit history, 'reason for change' capture, and electronic signature support, provide an out-of-the-box 21 CFR Part 11-ready solution for our FDA regulated clients," said Tim Butler, Infolinx Managing Director.
|
leveraging the extensive application and security configuration capabilities of Infolinx WEB
