Logilab - Model SDMS -Scientific Data Management System

In today’s laboratory environment , not all instruments have 21 CFR Part 11 features . Standalone instruments are an island, and data generated by such instruments is stored as paper records and or as electronic files in shared folders. There is limited control over e.g. excel & word documents. This scenario poses a big threat to compliance and a higher risk for data integrity

Logilab SDMS Software monitors data generated by PC based instruments via LAN and automatically uploads them to a secure central server. Moreover, instrument metadata such as who/which instrument, time of data generation etc is also captured. Data from standalone instruments can also be captured via RS232 and TCP/IP. Agaram’s Logilab SDMS also provides a unique tool called “CFR Gateway” for making noncompliant instruments compliant.

• QUALITY CONTROL
• RESEARCH & DEVELOPMENT
• STABILITY
• IN-PROCESS QC & PRODUCTION

Automated capture of Instrument & Human-generated data, metadata, Tag, Index, Catalog and Archive in a central repository.

• Automatic scheduler for instrument generated filesComplete Version control of all FilesTagging of data to index and catalogView file details and content in human readable format

GxP regulated laboratories can face audits at the ‘click’ of a button

• No searching of data or preparation for auditsPresent your raw and meta data electronicallyNo goof up or missing or mis-matched dataProve to your auditors that the data is indeed true copy and risk free

100% confidence & compliance for human generated data

• Manage document templates with version controlFill documents for GxP submissionManage excel, word and any other document with version controlApproval and release-controlled documents

Research data management made easy & simple

• Create research data repository and protect your IP
• Bring disparate sources of data (including documents) to a central repository
• Conduct electronic review and approval
• Collaborate with team more efficiently

Secure File and Database Storage

Storage of Files in a secured FTP server and meta data in the Database.

• Secured FTP Server to store instrument data files
• Secured SQL Server to store meta data
• Automated Data Parsing functionality
• Role based secured User access

Data is not in an island anymore, make it available

Storage of Files in a secured FTP server and meta data in the Database

• Exchange data of interest with external systems
• Parse and extract results from instrument data
• Integrate with LIMS, ELN and other systems
• Provide hyperlinks to data within the system

CFR Gateway
CFR Gateway has been designed to provide 100% data integrity and compliance for instrument software applications and standard desktop applications like Microsoft office.

Upon Operating System boot, CRF gateway will be loaded at the startup, for the users to login into the gateway first to access applications that are authorized to the users.

Any data created or modified by the user is full tracked and sent to server repository automatically. Even popular applications like Excel can be used with high level of data integrity and version-controlled.

How does the CFR Gateway work?

• CFR Gateway, when installed on windows, is a primary gateway
• Only authorized users can login
• Login/Logoff is audit trailed with date & time stamp
• After login, only authorized applications are viewable (non-compliant software)
• Non-compliant software can be run from Gateway application launcher
• Files generated are constantly monitored & moved to the server
• No access to files on local PC, downloadable from server
• Modified files moved to server with versioning
• The system consistently protects electronic records

Logilab SDMS designed for start-up to enterprise organisations
Capture data by monitoring ports & files generated by instruments without human intervention

Browser-based, Multi-site, service-oriented architecture & highly scalable
Logilab SDMS central single application server for distributed multi-site global organisations makes it easy to collaborate and scale

• Central data repository for start-up to multi location global organisations
• Service oriented architecture to PUSH & PULL data from instruments and human generated data
• Highly scalable to meet data volume challenges
• Simple & easy to use browser-based user interface

Build your Single Source of Truth
Capture & securely store instrument generated data files both raw & meta data

• Capture instrument reports as human readable pdf files
• Capture from standalone instruments via RS232, TCP/IP & Analog output (0-50v, 4-20mA).
• Capture human generated files like excel, other documents and forms

SDMS Explorer for data management
Logilab SDMS explorer similar to windows can show the files that are residing in the central server repository.

• Mimic original instrument software data folder structure
• View files based on data source (Instrument, document)
• View meta data files (standard & custom file attributes)
• Versions of files
• Download files
• Manually upload files
• Restore data with original instrument software structure
• View file content (pdf, txt, image, csv, excel)

Tagging & Viewing Templates
Tag captured files with meta data. Setup tag based hierarchy templates to view data in a  meaningful and informative manner:

• Tag data before or after capture of data
• Tag using Metalink® Android App
• Setup hierarchy templates for different types of data (QC, R&D, Process etc)
• View data using hierarchy templates (e.g. Project>Samples>Tests)
• Search based on tags

100% accuracy when interfacing instruments
Interfacing analytical & clinical instruments gives a significant data integrity confidence level leave alone the automation benefits

• Advanced configurable parsing engine to interface any analytical instrument
• Standalone instruments via RS232, TCP/IP and analog (0-50v, 4-20mA)
• Bi-directional interface of diagnostic IVD instruments
• API based integration like chromatography data systems
• Process instruments integration (PAT)

Logilab SDMS – Functional Highlights & Modules
Logilab SDMS Platform is very compressive solution that can take care of several laboratory processes. Following are Logilab SDMS modules and their core capabilities

Automated transfer of instrument generated files
File transfer can be scheduled either live or time-based using automated process for various instrument generated files including RS232, TCP/IP, Analog output instruments data either from local drives and network shared path.

Data Explorer search and view of file details
SDMS has a simple to user but very powerful user interface known as Data Explorer. It allows to explore server data similar to windows explorer. Users with appropriate rights will be allowed to view the files uploaded from instruments. It is also possible to search for specific files in explorer module. Folders with files and version of files are also displayed. Upload date/time and user who uploaded are also recorded.

Metalink® Android Mobile App
Data capture from standalone instruments can never be  easier than using Metalink® app. Users will have the comfort of working on the instrument while Metalink can serve as the missing link between the user, instrument and the data.

Standards Compliance
21 CFR Part 11 and EudraLex Annex 11 standards compliance is ensured by Qualis SDMS by providing the advantages of paperless record-keeping systems combined with document security and adequately maintained authenticity.

Workflow for Review and Approval
Logilab SDMS provides the functionality to setup a review and approval workflow for data to be published or change the status of data from one status to another. Data residing in the server can be checked, reviewed and approved by authorized personnel with an electronic signature.

Users, Group, Rights Management
User group-based access control can be configured easily. It ensures right permission is assigned for designated users. The following are the functionalities that are available:

Automated file versioning
Logilab SDMS has the functionality using which Automatic detection of modified files, upload of new file version of file and Secure on-line viewing of all file versions are provided. It ensures better control and easy monitoring of changes of data by the users.

Audit Trail
Audit trail module records every user and system action that involves the creation, deletion, editing of data. By providing the ability to extract and follow the records sequentially and chronologically, a secured, closely monitored and controlled tracking process will be in place.

Parsing Engine
Logilab SDMS has been designed with a Parsing Engine to parse the data as required by the users. Parsing engine enables uses to arrange, extract and present in such a way that only the portion of data of interest can be viewed and used in a user-friendly manner.

CFR Gateway - Data Integrity
CFR Gateway is a unique solution of Logilab SDMS intended to provide users facility to ensure control compliance (particularly in the cases of those which are not 21 CFR Part 11 compliant) by the way allocation access, folder and file access, including restrictions to right-click, rename, delete files in the controlled folders

Integration with other systems
Logilab SDMS has a highly flexible, industry- Logilab SDMS has a highly flexible, industry-standard and configurable Middleware which can be used to integrate with external system like LIMS/ERP.

Data Search, Tag template view
Logilab SDMS server data search is based on multiple options. Data can be searched based on file name, instruments, tags.