Description
A solution to prepare for GMP audits
LC DataKeeper is a Jeio Tech’s proprietary software that complies with FDA 21 CFR Part 11 regulations following the ALCOA Plus guidelines. It supports digital records, digital signs, and user access management, including audit trails for the equipment.
Jeio Tech’s equipment can be connected to LC DataKeeper to digitally record all experimental data. Only data approved by administrators through digital signatures can be recorded and exported, and permissions can be set differently by user. In addition, data can be viewed in real-time and automatic backup prevents data loss
Audit trails through digital signatures and issuing reports
- Permission for equipment connection is granted only to administrators.
- Thorough audit trails supported by always requiring digital signatures for creation, recording, and conclusion of any experiment on connected equipment.
- Reports are issued in the form of electronic documents containing digital signatures for a concluded experiment to ensure reliability.
Thorough security to prevent forgery and tampering
- Preventing third-party access by implementing AES-256 two-way encryption, the advanced encryption standard.
- Setting and assigning permissions for program function access, and maintaining transparent process quality by verifying user-specific logs.
Data backup and recovery
- Setting an automatic backup interval to ensure the recorded data is preserved without loss.
- Basic version: manual backup, Pro version: automatic backup.
Convenient equipment connection and experimentation
- Capable of managing up to 100 connected equipment for the Pro version.
- Intuitively grasp the experiment progress through real-time graphs.
- More precise data analysis through zoom-in/out function.
- Graph extraction as a PNG image file when completing data through experiment initiation and conclusion.
- Data Storage Interval Setting (seconds)
– You can set the interval at which data is recorded within the range of 1 to 999 seconds.
– This setting is only available for Admin accounts.