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Fluxa’s PKM software is a web-based application that seamlessly manages product and process specifications throughout the drug development lifecycle. Inherently designed to facilitate collaboration, it enables global sites, functions, CDOs, CMOs, and CDMOs, to work together to scale recipes and execute technology transfers. And because it is built using modern digital technologies, it provides enterprise-grade security, scalability, and the ability to integrate with other systems such as Enterprise Resource Planning (ERP), Electronic Lab Notebooks (ELN), Laboratory Information Management Systems (LIMS), and Manufacturing Execution Systems (MES).

Fluxa PKM Software Features:

Visual Process Flows
A web-based, intuitive, drag-and-drop user interface simplifies and standardizes the creation of product and process specifications that conform to ISA-88.
Parameter Calculation Engine
A structured, configuration-driven approach to efficiently manage process parameters and calculations without the need for Excel.
Real-time Facility Fit
Predictive algorithms help you understand which facilities can support your process in real-time, as it’s being designed and edited in the application.
Global Team Collaboration
Seamlessly access recipes, tag comments, attach documents, check-in/check-out unit operations, and utilize built-in workflows to manage approvals.
One-click Compliance Document Creation
Eliminate manual data collection and review cycles with automatic Word and PDF document generation.
CFR-11 Compliant
Designed to operate in a regulated environment, PKM provides full audit logging, electronic signature records, version management, and role-based access.
Contact us to learn more about the products, services, and solutions that NECI provides to Cell & Gene Therapy organizations.