Electronic Document Management (eDM)

ShujuMetrics’ Electronic-Document Management (eDM) System is configured for study documentation tracking from utilizing a commercial software package from Seafile™. ShujuMetrics’ eDM System is CFR-21 Part 11 compliant and is available at a fraction of the cost of other commercial eDM Systems.

FAQ of ShujuMetrics eDM System

  • Where is the system hosted?

The system is hosted on firewall protected, ShujuMetrics company

servers. The primary servers are located in New Jersey, U.S., and

the backup servers are located in Beijing, China and Shanghai, China.

  • What level of access does hosting provider and their staff have

   to the data?

The eDM System is hosted on ShujuMetrics’ controlled servers. No

third party hosting is used. ShujuMetrics has strict SOPs in place regarding access authorization management. Only the sever administrator has full access to the servers. Any other employees, or users need to go through a formal application process to be granted server access. The system allows controlled and configurable authorized access to pre-assigned folders. 

  • How is data access audited trailed and logged?

The system provides a complete audit trail for every activity, It controls data access via account and password

authentication. Through a generic logging mechanism, the system can record all the user’s activities such as the user’s IP address, login time, document revisions etc.

  • What type of data integrity measures are in place?

On the end user side, Seafile's file syncing function is very stable and able to handle file conflicts. In addition, Seafile has complete file version control to avoid the loss of data. On server side, Seafile has several features to prevent the loss of data, including:

  1. backup and restore
  2. a tool to check the integrity of file
  3. the ability to sync between servers allowing for instant backup

The system is used as a tool for clinical monitors and other clinical trial users to automatically upload study related documents. On a weekly basis, ShujuMetrics’ Document Management Specialist check the data integrity of the eDM System and send out notifications to study personnel regarding missing data/files.

  • Is the data encrypted at rest?

Yes, Seafile provides a feature called encrypted library to protect your privacy. The file encryption/decryption is performed in the client-side when using the desktop client for file syncing. The password of an encrypted library is not stored in the server. Even the system administrator is blinded from viewing the file contents.

  • Is the data encrypted in transit? If so, which cryptographic systems are in use, which algorithms, etc?

Yes, Data is encrypted during transfer. Seafile only supports syncing via a self-designed protocol. Every Seafile desktop client has a unique private key. When a client and a server connect, they will exchange public key and negotiate a session key. The session key is derived from cryptographically secure random number with PDKDF2 algorithm. Exchanges between the client and the server are via RSA encryption. This session key is used to encrypt the data transfer with an AES-256/CBC algorithm.

  • How are user access provisioned?

Through administrator’s centralized configuration and authorization management, users can manipulate files using the following functions:

  1. Groups with file syncing, wiki, discussion.
  2. Online file editing and comments.
  3. Sharing sub-folders to users/groups
  4. Sharing single file between users
  5. Sharing link.

  • What is the eDM System availability?

A backup server ensures the availability of the system.

  • How much storage is available? Are there any limits in number or sizes of files?

The storage space has no limit, but to guarantee adequate performance and upload speeds, we have placed a limit of 1Gbyte per file.

  • How long is the data stored?

The length of time files are stored varies with the sponsor’s needs. Permanent storage of files and data is available. File backups occur daily. The original document is migrated to backup servers.Type your paragraph here.