Name: BSI eTMF
Author: BSI (Business Systems Integration)

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BSI eTMF is a trial master file (eTMF) management solution offered by BSI Business Systems Integration AG. According to the vendor, it is designed to meet the needs of clinical research organizations (CROs), pharmaceutical and biotechnology companies, medical device manufacturers, and academic research institutions. BSI eTMF aims to provide a complete and organized system for managing trial master files, making it suitable for organizations of various sizes, including pharma, biotech, MedTech sponsors, CROs, and academics (SMO).

## Key Features

According to the vendor, BSI eTMF offers comprehensive functionality for trial master file management. It includes features such as document plans, reviews and approvals, exports, archiving, and more. The solution aims to cover all aspects of trial master file management, providing a complete and organized system.

The vendor states that BSI eTMF is designed with a user-friendly interface, aiming to make it easy for users to navigate and operate. It provides intuitive features and workflows, which are intended to minimize the learning curve for new users. Users can easily upload, link, and save documents, as well as view them using the integrated document viewer functionality.

The vendor claims that BSI eTMF can be easily implemented within an organization, allowing for a smooth transition to the new system. It is designed to seamlessly integrate with existing systems and processes, aiming to minimize disruptions to workflow. The solution also offers flexibility in terms of customization and configuration to meet specific organizational needs.

According to the vendor, BSI eTMF is an affordable solution that aims to offer the lowest total cost of ownership in the market. It provides value for money with its comprehensive functionality and competitive pricing. Organizations can potentially benefit from cost savings without compromising the quality and effectiveness of trial master file management.

BSI eTMF includes the BSI Portal, which, according to the vendor, enables seamless collaboration with study sites. Users can plan the documents that should be part of the sponsor's eISF (Investigator Site File). Site personnel can easily upload or view documents through the portal, aiming to enhance communication and efficiency.

The vendor claims that BSI eTMF ensures regulatory compliance and data protection in accordance with industry standards. It aims to adhere to data privacy regulations, providing a secure environment for sensitive trial data. The solution is intended to support organizations in meeting regulatory requirements and being audit and inspection ready.

BSI eTMF offers a sophisticated granting and access rights system, according to the vendor, allowing organizations to control user access. Users can be granted specific permissions and roles based on their responsibilities and needs. This feature aims to ensure data security and confidentiality, preventing unauthorized access to sensitive trial information.

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Document management systems (DMS) encompass a set of capabilities for storing, sharing, and converting documents and files in a way that reduces dependence upon, or eliminates entirely, hardware and paper document generation and storage. Central to document management is imaging, file type conversion, versioning, and metadata management with document editing and access controls. Document management type features might also be contained in an enterprise content management (ECM) system or a digital asset management (DAM) system.

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BSI eTMF

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What is BSI eTMF?