COMPLIANCE OF E2R WEIGHING RECORDS WITH 21 CFR PART 11

21 CFR PART 11

E2R Weighing Records software is compliant with 21 CFR part 11 and EU GMP part 4, Annex 11. The system is now expanded with new functions that secure and monitor work carried out by different operators.

Audit Trail, a PC module, registers each modification of the database carried out in E2R Weighing Records software. Detailed information concerning each action is saved: date, time and type of the modification, name of modified field, previous and current value, name of an operator introducing the modification, name of the weighing instrument. The function enables to monitor the activity and allows to correct implemented changes if necessary.

Scale Audit Trail module enables readout of all actions carried out using the weighing instrument via E2R Weighing Records software.

E2R Weighing Records software features numerous security functions:

password settings: requirements regarding characters, digits, letters and periodical password change,

auto log out,

electronic signature,

three validation levels: signature, confirmation, authorization

assigning permissions to operators

granting/denying access to data management

backup