Phoretix 1D 21 CFR - Overview

Phoretix 1D is the premium 1D Gel analysis product on the market. Now for labs that need to meet a higher level of data security, there is an advanced version which helps compliance with the 21 CFR Part 11 rules.

It enables the use of secure log-ins, electronic signatures, audit trails with complete data integrity and security for your 1D analysis projects.

System Access and Electronic Signatures

Phoretix 1D 21 CFR uses the Windows security model to restrict access to the software so you can use your regular user names and passwords. User logon is required when starting the software and each user can be set up as either a Supervisor, User or Viewer. Supervisors can then approve completed experiments using an electronic signature.

Data Integrity and Security

Data is stored in Secure Storage Area which can be set up by IT administration. This ensures that data can only be accessed correctly through Phoretix 1D 21 CFR as any data corruption is automatically detected.

Audit Trails

Phoretix 1D 21 CFR keeps audit trails for all the actions each user performs within the software modules including approval signatures, storing a version of the experiment, user logons, all gel analysis actions (e.g. band detection). Each record includes the name of the user together with time and date of action.