Frequently Asked Questions
Could you explain what 21CFR Part 11 is?
The US FDA (Food & Drugs Administration) Code of Federal Regulations 21 Part 11, is an extension to the existing regulations that defines which electronic records and signatures that are to be considered accurate to replace paper records for the Pharmaceutical and Medical industry. Our system has been designed to assist companies comply with these regulations.
Would the 21CFR Cloud product be suitable for my company?
The product has been designed for companies which want to use electronic means to securely replace their paper records to comply with 21 CFR Part 11 regulations for the Pharmaceutical & Medical industries. Also if you work within, and want to be compatible with, the US Pharmaceutical & Medical industry and to streamline your record taking accordingly, initiating a 21 CFR Cloud would be advantageous.
Are there any Apps for the 21CFR Part 11 WiFi system?
To control security of access to the 21CFR Cloud, at present no Android or IOS Apps have been released.
Can I use one of your standard WiFi data loggers on the 21CFR Cloud?
Our 21 CFR WiFi data loggers are specially designed and produced to work with the 21CFR Cloud. None of our standard loggers will communicate with the 21CFR Cloud and they cannot be upgraded to function on it.
Is there a ‘Free’ or ‘Personal’ account for the 21CFR Cloud?
Due to the more complex administration involved in 21CFR, the basic Free and Personal account that are on our standard Cloud, are unsuitable for 21CFR administration. The 21CFR Cloud is intended as a professional service for business.
As with the standard WiFi sensor system, is there a PC based version?
As a version running on a local PC cannot be adequately secured and controlled, no version using a local PC is currently available.
How can I initiate a 21CFR Part 11 Professional Cloud account?
Go to the Software Downloads section and download and install the latest 21CFR WiFi Sensor Software. On your Windows PC run the program and click on the orange Sign-Up button and follow the on-screen instructions to setup an account. Once it has been setup and you have a 21CFR compatible WiFi data logger, click on the ‘Set-Up Device on the Cloud’ button and follow the on-screen instructions.
How is 21CFR different to the EasyLog Cloud?
21CFR Part 11 is an American FDA regulation covering electronic data records for food and pharmaceutical manufacturers. 21CFR-compliant systems require our 21CFR designated hardware and our separate 21CFR cloud service.
My EL-USB Logger will not connect. How do I check and resolve Battery and Driver issues?
We’ve put together a help guide on battery and driver issues, check it out here.
What happens if I forget my login details for 21CFR USB software?
An administrator for the software will need to reset your password from the <Admin> <Edit User> menu. The next time you attempt to log in it will ask you to enter and confirm a new password. For further guidance on software use, please reference the 21CFR Software Guide.