小型申报文档管理系统

miniDMS for eCTDmanager - eCTD Document Management System

Document Management in a Smaller Package

While there are many advantages to using a Document Management System (DMS) over simple file system storage, small organizations often do not have the necessary technical knowledge or finances required to invest in such systems. Despite this, the requirement to effectively manage documents remains a pressing issue.

At EXTEDO, our experience of working with dozens of small to middle-sized organizations has enabled our team to develop the ideal integrated document management solution – miniDMS. As an optional module for eCTDmanager, miniDMS provides some essential functionalities and benefits of a full-blown commercial DMS repository, but with significantly less complexity.

Benefits

  • Secure, efficient management of all documents related to regulatory activities 

  • Easy access to documents

  • Document version & rendition control

  • Controlled and improved document distribution 

  • Fully integrated in eCTDmanager interface

  • Disaster recovery

  • No lost files

  • Improved regulatory compliance

  • Swift and cost-effective implementation and validation

  • Cost savings by lowering the total costs of ownership (TCO)

  • Easy to use, user-friendly

Securely manage regulatory data throughout the entire submission lifecycle

miniDMS enables you to securely manage regulatory data throughout the complete submission compilation and publishing process, ensuring compliance with standard documentation guidelines. With miniDMS you can manage administrative and archiving tasks more efficiently, streamlining your business processes and saving time and resources.

EXTEDO’s miniDMS integrates directly into your existing eCTDmanager project database. Documents can be added to a submission directly from the miniDMS repository or by selecting them from within a local file system. miniDMS also provides support for importing dossiers and other structures such as SPL. To locate content already stored within miniDMS you can readily search by name, keyword, content, or any other metadata attached to a file. This allows for a quick and easy access of documents.

With its version control and permissions management, miniDMS for eCTDmanager enables submission documents to be securely accessed, updated and managed. In addition, its built-in encryption and authentication systems protect your documents against illicit access. To eliminate the risk of lost documents, miniDMS creates back-up files that can be uploaded to an off-site data center for storage and disaster recovery. If you are using eCTDmanager and do not already have a DMS to support the management of your submission content, then miniDMS is the essential solution for your business.

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