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
21 CFR part 11 compliance
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.
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.
eSIGN module adds an encrypted digital signatures to electronic records (data and configuration files).
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.