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Produktbeschreibung
11.10.2018  |  26x
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Scientific Data Management System

Data Integrity - CFR Compliance - cGMP

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.

- Multi-site organisations (distributor 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)


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 authorized access to data, audit trail & version control.

- Capture & organize data in central repository
- Raw & metadata capture
- Independent of instrument& model
- PC based & standalone instruments


- Architecture: Client/ Server Application
- OS: Windows (XP, Vista, Win 7 & above)
- Database: MS-SQL Server
- LogiLAB SDMS Architecture

 

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