Innovatum Products - Overview
Innovatum has built enterprise-class software systems to meet the compliance challenges of manufacturing, inventory and supply chain operations in regulated industries since 1993. Though our industry focus is centered in the Life Sciences (i.e. pharmaceutical, medical device and biotech), Innovatum serves multiple vertical markets for which compliance is vital, including the Chemical, Food Manufacturing, Financial and Gaming industries. Consequently, Innovatum's software systems are ideal for meeting regulations such as FDA 21 CFR Part 11, Sarbanes-Oxley, HIPAA, Gramm-Leach-Bliley and more.
As a result of this long-standing focus on regulatory compliance, our software is developed using strict disciplines of validated systems in highly regulated industries. Consequently, the quality of our software exceeds generally-accepted norms and can readily be validated within operating environments that require validation. For industries that do not require validation, this means that Innovatum products have passed the strictest quality assurance standards, and therefore perform more reliably and consistently from the outset. The following represents our current line of compliance software systems:
ROBAR
The ROBAR Enterprise Label Management System is a complete bar code and RFID label design, review, approval, printing and data management system built explicitly for the needs of FDA-regulated pharmaceutical, medical device and biotechnology manufacturers. ROBAR manages the entire label life-cycle - from initial design and review to obsolescence - with comprehensive security and audit logs for compliance with FDA 21 CFR Part 11 and equivalent regulations. Its XML interface ensures seamless integration with virtually any ERP, PLM or similar enterprise system. ROBAR's enterprise architecture enables central management and administration of labeling personnel and SOPs at any number of sites across the WAN, regardless of physical location. In short, ROBAR provides the ultimate in simplicity, security and compliance for labeling in FDA-regulated manufacturing environments.
DataThread
Innovatum's Data Audit and workflow product was designed specifically for compliance with internal and external audit requirements. Without requiring any changes to the underlying applications, DataThread provides the technical remediation needed for compliance with Sarbanes-Oxley, Gramm-Leach-Bliley, HIPAA and FDA's 21 CFR part 11. Additionally it has a unique workflow and notification module which can help in automating paper and labor intensive processes within any iSeries and AS/400 environment
InnoTasc
InnoTasc is a simple, yet robust, web-based tool for automating multi-step work processes among any number of personnel, departments and physical locations on a Wide Area Network (WAN). InnoTasc allows authorized users to electronically route any file type (e.g. PDFs, JPEGs, Word Documents, etc.) for review and approval. It can also be used without a file attachment to automate and track collaborative tasks involving multiple personnel, departments or even external business partners. Thus, InnoTasc is ideal for managing critical documents and tasks in highly regulated environments. Users are notified of new tasks via e-mail with a link to InnoTasc's secure web portal. There, authorized users can review electronic documents, as well as view workflow activities and statuses in real-time; providing greater visibility and accountability for all parties involved. InnoTasc also retains a comprehensive audit log of all workflow activities, which enables compliance with regulations such as FDA 21 CFR Part 11 among others. And the best part? InnoTasc is available at a fraction of the cost of competing document management systems.
ROPICS
ROPICS (Radio Frequency Order Picking and Inventory Control System) is a system designed to allow remote client computers to access and control various functions of a central ERP implementation. The MES component of ROPICS is today responsible for the correct and validated manufacturing of several household medicines, and can be interfaced with any ERP system.