LC DataKeeper

LC DataKeeper

A data integrity solution for pharmaceutical/biotech research.
Generate reliable data with software compliant with FDA 21 CFR Part 11 regulations.

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Compliant with the FDA 21 CFR Part 11
LC DataKeeper supports complete data integrity

  • A Must-have software for drug and pharmaceutical research
  • Complete prevention of tampering through digital signature and security
  • Long-term data retention with data backup and recovery functionalities

 

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.

What regulation is FDA 21 CFR Part 11?

In 2005, a pharmaceutical company in the United States violated Data Integrity regulations, prompting strict management of all data related to pharmaceuticals. FDA 21 CFR Part 11 is a regulation that ensures data integrity for pharmaceutical-related research results. 

JEIO TECH’s LC DataKeeper, 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. 

 

Key factors for data integrity

 

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.

 

LC DataKeeper supported Equipment

We will continue to develop and expand the types of equipment that can be connected.

 

Notes on product handling

  • The company, upon confirming payment for the Iicense fee, proceeds to send the license activation key fiIe to the user via the emaiI provided.
  • Notes on withdrawal of subscription : Users who have entered into a license purchase ageement with the company have the right to withdraw their subscription within 7 days from the date of purchase. However, if the user has made the payment for the Iicense fee and received the license activation key file from the company via email, withdrawal of the subscription is restricted.
  • The company is not responsibIe for data storage issues arising from communication probIems between the equipnent and the PC where LC DataKeeper is installed during its use.
  • LC DataKeeper is a program designed for recording data generated by the equipment in accordance with FDA21 CFR Part 11, not for the purpose of equipment control.

 

To download the installation program and purchase the license

The installation program and license can be purchased directly through www.labcompanion.com or via our sales representatives. We offer a free trial version for 30 days.

 

Document support for GMP audits

1. S/W User Manual
2. S/W Test Procedure
3. Digital Signature Verification
4. S/W Release Note
5. External Audit Test Report

 

Computer Program Copyright Registration Completed

We have registered the program copyright with the Copyright Commission to protect the value of the program and enhance its reliability. (Copyright Registration Number: C-2024-012176)

SKU: SSA11001 Category:
License Basic Pro
Duration of use permanent permanent permanent
Max. number of equipment to connect 4 ea 100 ea
Manual backup and recovery ○ ○
Data storage ○ ○
Event/log management ○ ○
Warning record function ○ ○
CSV file extraction ○ ○
User management ○ ○
PDF Extraction for digital signatures – ○
Automatic backup and recovery – ○
Validation document provision – ○
Cat. No. SSA11001 SSA11002