Yes.

Yes. The software is cloud-based, can be used from any device connected to the Internet, and is active 24/7.

Yes.

The software is installed on secure AWS (Amazon) servers and is divided into three areas for security needs: Content, Database, Files.

Yes.

The system is validated with periodic re-validations, and each client receives validation documents and a certificate of compliance with 21CFR Part 11, ISO 13485: 2016, EU GMP Annex 11: Computerized Systems, and 21CFR Part 820.

There is no user limit.

You can create as many users as you need and they can all work on the system at the same time.

There are several types of users:



  • Admin user – who holds management and system settings permissions for the client


  • Full user – who has full access to all system activities & parts of the system.


  • Regular user – who can access a variety of activities, perform tasks, approve documents and take part in processes.


  • Viewer user –¬†authorized to perform training and view effective documents.


  • External user – designed¬†primarily for work with suppliers or subcontractors.


Almond system has a backup/survival system that operates on two levels:



First, the system itself operates in parallel on two servers located in different areas. If one of the servers crashes, the other server’s work will be automatically logged in, so that the system will continue to work even if one of the servers crashes.



Similarly, the information on the system is managed simultaneously on two servers so that the clients’ information is also protected against the fall of one of the servers.



Once a day, the entire database is backed-up automatically in a way that provides recovery capability in emergency / extreme situations.



In addition, the system allows the admin to configure iterations of backups to the system content or parts of it, downloading and saving them locally.



In the event of a collapse of the communication network, the company that uses the Almond system can reach any item/content without the need for active communication.

No.



Implementing the system is a simple process that consists of filling out questionnaire templates, uploading the client’s documents to the working & testing environment, and performing a short training on the use of the system.
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