Cunesoft
Cunesoft, part of Phlexglobal, provides SaaS regulatory software for life sciences and regulated industries. It supports pharmacovigilance, electronic submissions, document management, and regulatory info management. Its master data approach ensures a single source of truth, boosting speed, quality, and compliance.
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Cunesoft Overview
Cunesoft, a Phlexglobal company, offers innovative online regulatory software tailored for life sciences and other regulated industries through a Software as a Service (SaaS) model. The platform serves as a comprehensive solution for various regulatory processes including pharmacovigilance, electronic submissions, document management, and regulatory information management. Utilizing a master data management approach, Cunesoft creates a single source of regulatory truth that enhances data integrity and consistency. This unified system enables faster workflows, improved quality, and stronger compliance adherence, helping organizations streamline regulatory operations efficiently.
Features
Regulatory Information Management (RIM)
Electronic Common Technical Document (eCTD) Submissions
Document Management System (DMS)
Audit Trail and Compliance Tracking
Cunesoft Pricing Overview
Cunesoft Score
Smyte Score
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FAQs
Cunesoft is a cloud-based regulatory compliance software developed by Phlexglobal, designed to streamline regulatory processes in the life sciences and other regulated industries. It offers features such as pharmacovigilance, electronic submissions, document management, and regulatory information management.
Cunesoft is primarily aimed at organizations in the life sciences sector, including pharmaceutical companies, biotechnology firms, and medical device manufacturers, that require robust regulatory compliance solutions.
Cunesoft is built to fulfill regulatory needs holistically and end-to-end, adhering to standards such as FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.
While specific training details are not publicly available, organizations interested in Cunesoft should inquire directly with Phlexglobal to understand the onboarding and training support offered to new users.
Prospective customers can visit the Cunesoft website or contact Phlexglobal directly to request a product demo, obtain more information about the platform’s features, and discuss pricing and support options.
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