Logilab SDMS designed for start-up to enterprise organisations

Capture data by monitoring ports & files generated by instruments without human intervention
SDMS Software
lab data integrity

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

Build your Single Source of Truth

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SDMS Software

SDMS Explorer for data management

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

Tagging & Viewing Templates

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

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100% accuracy when interfacing instruments

Interfacing analytical & clinical instruments gives a significant data integrity confidence level leave alone the automation benefits

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

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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.

It requires no manual intervention and ensure Error-free operations along with time and efforts saving

21 cfr part 11 regulations

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.

Data Explores provided better user experience due to its simplicity at the same time ensures detailed view of data.

Like windows explorer the Logilab SDMS explorer can show the files that are residing in the central server repository. Files can be seen based on the instrument and schedulers.

  • Check files and attributes
  • Versions of files
  • Download files
  • Manually upload files
  • Restore data
  • View file content (pdf, txt, image, csv, excel)

 

21 cfr part 11 compliance

Metalink® Android Mobile App

Data capture from standalone instruments can never be more 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.

  • Select instrument to be used & lock
  • Select LIMS or ELN orders & link data to be captured
  • View data captured from instrument
  • View parsed data
fda 21 cfr part 11

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.

The main advantages are: High availability and easy access of records, validation and tracking of records, data integrity, Audit trail information, authorised user access to data.

It ensures that users can have an accurate, secure, standard-compliant and paper-less transaction system which is highly reliable for easy Patent filing process and handling patent disputes (if any).

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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.

It ensures better categorisation, user accountability and control of data to ensure error-free operations.

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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:

  • Built in user management
  • User Groups
  • Configurable Roles & Rights
  • Integrate with Microsoft Active Directory Services (ADS)
  • Password Policy Settings
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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.

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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.

In order to meet FDA 21 CFR Part 11 and EudraLex Annex 11 standards compliance, Audit Trail is designed. It is to record all the actions of users and system. The following are the key features:

  •  100% audit trail of files uploaded, downloaded, restored & error
  •  Versioning of data
  • Services start/stop monitoring
  •  Communication failure
  •  Electronic Signatures for all the user actions
  •  Audit trail review and export
21 cfr part 11 compliance

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.

It reduces the complexity of operations, time and cost saving, reduction of errors, uniformity and consistency of data extraction as well as better user experience.

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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

It ensures application access security, ensure 21 CFR Part 11 compliance, and protection of data/files/applications from unauthorised use.

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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.

It ensures the time and cost savings and better user experience due to reduced complexity of operations and maintenance. It also ensures error-free operations, uniformity and consistency of data extraction and processing.

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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.

Tag template is a unique way to view data based on the tagging template hierarchy. This is in essence not a search but a direct access to data in a meaningful structure called tag hierarchy. Quality control team can create templates based on the products/batch/test whereas research team can search based on project/sample/test etc.

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