LogiLAB SDMS

Scientific Data Management System

LogiLAB® SDMS is a data management system for laboratories in the regulated industry to achieve data integrity (ALCOA) and 21 CFR Part 11 compliance. LogiLAB SDMS can manage raw data along with metadata generated by laboratory instruments and other human-generated data (Excel, reports and documents). Maintain a single source of truth for GMP data.

LogiLAB SDMS is a completely non-intrusive software that can be operated mostly on its own with minimal or no intervention required by users. Its automated schedulers can capture data generated by any type of instrument independent of the manufacturer and model. Instrument data files generated by PC controlled instruments and data generated by standalone instruments can be captured via RS232 or TCP/IP ports.

LogiLAB can be deployed in quality control, process, R&D, contract research, pre-clinical and clinical research areas to achieve data integrity and 21 CFR Part 11 compliance.

Traditional methods of storing data files in a network drive or a file server are weak solutions when it comes to complying with 21 CFR Part 11, GLP, GMP and basics of data integrity based on ALCOA. LogiLAB SDMS provides a controlled environment with authorised access to data, audit trail & version control.

Scheduler

Automatic scheduler based instrument data capture.

Original Strucuture

Maintain original folder structure of source data.

Push & Pull

Push or pull data from instrument to server.

FTP

FTP is the backbone to transfer  files to server.

Tagging

Manual & Automatic extraction  & tagging of relevant data.

E- Signature

Place electronic signature on files based on workflow.

Traceability

Full audit trail for upload/ download of data.

Integration

System is designed to integrate with any  external system.

  • Capture & organise data in central repository
  • Raw & metadata capture
  • Independent of instrument& model
  • PC based & standalone instruments
  • Quality control labs
  • R&D labs
  • Analytical method development labs
  • Comply with data integrity guidelines
  • Labs transforming for the digital era
  • LogiLAB CFR Gateway” help comply with 21 CFR Part 11
  • Instruments without inherent support can become compliant
  • Architecture: Client/ Server Application
  • OS: Windows (XP, Vista, Win 7 & above)
  • Database: MS-SQL Server

LogiLAB SDMS Architecture

  • Multi-site organisations (distributer architecture)
  • Share data to a corporate location anywhere
  • Authorizes personnel view data from multiple sites
  • Data synch engine copy data to corporate sites (disaster avoidance/ recovery)

CFR Gateway Module- A Unique Solution for Data Integrity & 21 CFR Part 11

Several Instruments do not have 21 CFR Part 11 capabilities

  • Data integrity maintenance is also a challenge for instrument systems
  • LogiLAB CFR Gateway is a unique solution that can help solve this problem
  • LogiLAB CFR Gateway is similar to a virtual wrapper for any non-compliant application
  • Users login through wrapper environment to access non-compliant software
  • User Login/log-off is audit trailed (Controlled Access)
  • Data generated/modified by an instrument is watched & uploaded with version control
  • Modification of data is always versioned & audit trailed
  • No need to harden windows to protect data. CFR Gateway will

Benefits of CFR Gateway

  • 21 CFR Part 11 & EudraLex Annex 11 compliance
  • Do not replace old/ expensive instruments for compliance (Solution: LogiLAB SDMS)
  • Single software for all your compliance needs
  • No additional investment in individual instrument-based software for compliance

LogiLAB SDMS Key Capabilities

Backup

  • Automated Capture of raw data and meta-data generated by any analytical instrument
  • LIVE streaming of files & folders
  • Secure FTP storage for storing the data.
  • Secure backup with version control and de-duplication technology
  • CRC check for file version control
  • Push or Pull data from instrument to server

Explore Data

  • Maintain original folder structure of the source data
  • Easy explorer type of access & retrieval of data based on user roles and rights
  • Single-click data open/ download/ restore
  • Explore data based on template
  • Ability to view Versioned data

Tagging

  • Creating Hierarchy & Non-Hierarchy template
  • Lock Instrument to capture tag data
  • Auto unlock after tag data captured
  • Pre & Post tagging for capturing data
  • Easy to Search data

E-Signature

  • Electronic records & electronic signature support for 21 CFR Part 11 compliance
  • Place electronic signature on files based on workflow

Traceability

  • Audit trail for all the activity
  • Audit trail history for each data
  • Workflow history for each data
  • Upload Queue & Upload fail mechanism

Additional Features

  • Supports built-in and windows ADS based user authentication
  • Supports RS232, TCP/IP and PC-based instrument
  • Portal for Lock instrument to capture data with tags

CFR Gateway

  • Make non-Compliant Instruments Comply with 21 CFR Part 11
  • Captured Data based on Gateway user
  • Helps in 21 CFR Part 11 and Eudralex Volume 4 Annex 11 compliance
  • There is no need to replace old and expensive instruments for the sake of compliance. LogiLAB SDMS can help you achieve compliance.
  • Use single piece of software for all your compliance needs
  • No need to invest in an individual instrument based software for becoming compliant

Integration

  • Automatic parsing of files and extraction of meaningful content
  • Export of data to external systems and integration with ELN/ LIMS
  • Brochure

  • Presentations

Why LogiLAB SDMS is important for Data Integrity ?

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