The basic profiles available include current and previous validation criteria of the following regions: CA eCTD Validation Criteria, CH eCTD Validation Criteria, EU eCTD Validation Criteria, EU NeeS Validation Criteria, EU VNeeS Validation Criteria, GCC eCTD Validation Criteria, GCC NeeS Validation Criteria, US eCTD Validation Criteria, US CDRH eCopy, ZA eCTD Validation Criteria. In addition to the aforementioned current and previous criteria, LORENZ may also opt to add draft criteria should they become available from the authorities and mark them as such accordingly. To know exactly which versions of the criteria are supported, please refer to the Release Configuration Sheet (downloadable at the bottom of this page).
Please note that all eValidator versions contain all basic profiles. However, with the free eValidator Basic you have to decide upon installation which profile you wish to use. All other versions allow you to switch between profiles. Basic profiles address the exact requirements of the official validation criteria as published by the regulatory agencies.
If you are an eValidator ONE user, you can access any of the basic profiles.
The eValidator Enterprise may - pending licensing - also include extended profiles (Good Regulatory Practice Profiles) that provide more in depth checks.
The version you will be downloading will contain all country and submission profiles available for the Basic version. Upon installation, you will be asked to choose one. The profiles are identical to the ones found with our regulatory agency customers. If you are an eValidator ONE user, you will be able to switch profiles.