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  6. QLIFICA eTMF

QLIFICA eTMF

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QLIFICA

last updated:Oct 03, 2025

SOLUMINA
SOLUMINA
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Achieving efficient document management through information aggregation and cloud-based workflows.

This is a cloud service that handles document information related to clinical trials and clinical research online. It builds a classification structure for each trial, enabling the aggregation, organization, workflow management, and storage of document information. It can be used by companies such as pharmaceutical and medical device manufacturers, CROs, and medical institutions like hospitals and clinics. ■ Features and Benefits of QLIFICA eTMF Point 1: Document files are stored in a high-security environment. Point 2: Management is possible with classification structures such as the TMF Reference Model. Point 3: Workflow management for reviews, approvals, etc. Point 4: Secure sharing of documents with team members and relevant parties. Point 5: Electronic original document management compliant with ER/ES guidelines. Point 6: Clarification of the history of changes and accountability. Please feel free to contact us for more details.

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QLIFICA eTMF

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  • Related Link - https://solumina.co.jp/service/qlifica-etmf/

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■Cases for Consultation - I want to store documents based on rules to prevent loss and streamline inspections and reviews. - I want to strictly manage access permissions for each document. - I want to create an environment where the team can securely and smoothly share information. ■Benefits of Implementation - Clarification and standardization of storage rules through document classification based on the TMF Reference Model and others. - Prevention of editing errors and automation of document status management through flexible workflow and permission settings. - Automatic recording of operation history to visualize the background and responsibilities, also supporting electronic original document management in compliance with ER/ES guidelines. - Centralized understanding and sharing of document management status across the entire team. ■Main Features - Document registration and storage through folder view/classification view. - Management of approvals and reviews through flexible workflows. - Document search. - Document version management. - Compliance with ER/ES guidelines.

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QLIFICA eTMF

QLIFICA eTMF

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SOLUMINA

SOLUMINA

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Our company is an SI firm that provides total support from research analysis and proposals to maintenance in solving our customers' IT challenges. We offer a wide range of consultations, including support for the formulation and execution of IT strategies, as well as modifications and operations of existing systems. Additionally, we provide technical support for system development to electrical manufacturers and system integrators.

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