GLP Modules

To comply with regulatory requirements, optional GLP modules can be activated with each emka TECHNOLOGIES’software.

Data consistency, reliability and integrity are ensured by:

  • usersMANAGEMENT module, for the control of access rights
  • auditCENTRAL software, for audit trail
  • eSIGN module, for encrypted electronic signatures
  • studyMANAGEMENT module, to associate data files to a study

Benefits

1

21 CFR part 11 compliance

2

GLP compliance

Description

Access control

usersMANAGEMENT is designed to control access to each of emka TECHNOLOGIES software programs. It gives each user an access identification by login and password, for one or more emka TECHNOLOGIES software.

Access rights are characterized by a level (e.g. simple user, administrator) with an optional expiry date and a logout period.


Audit trail

The auditCENTRAL software is a Windows service that collects audit lines sent to Windows event logs of all client computers and keep them into a database.

Each entry in the audit trail contains a list of all actions done on emka TECHNOLOGIES programs that affect or potentially affect raw or processed data, such as:

  • the date and time of the action
  • the user who performed the action
  • the computer on which the action was performed etc.

Electronic signature

eSIGN module adds an encrypted digital signatures to electronic records (data and configuration files).


Study management

studyMANAGEMENT module helps users organize a set of experiments, configurations and corresponding data into one study. A study tag is applied to files generated by emka TECHNOLOGIES software. The tag allows emka TECHNOLOGIES software to identify which study a file is from.

Services

Support

Training

Validation

Data analysis

For more information or for quote request, please contact us