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Logilab SDMS FAQ

Frequently Asked Questions (FAQ) about Logilab SDMS 

Frequently asked Questions

Logilab SDMS is generic software designed and developed by Agaram Technologies to handle scientific instrument data from any analytical instrument. It can facilitate data management with access control. System will perform scheduled data capture, cataloguing, archival and facilitate restoring data and has capabilities to extract data of interest from instrument output to be pushed to external systems like ELN, LIMS or ERP.

The data files captured are stored as flat files in a secure FTP file server as an encrypted file name. Data access and viewing is controlled through user rights providing data security. The meta-data like data source, date/time, file size, checksum and user entered tags along with parsed and extracted data is stored in the database.

Full text indexing allows strong search facility ensures availability of required data instantaneously. Built-in integration tools allow you to integrate external systems as well.

  • Fully automated secure file handling by SDMS scheduler
  • Version control and version history maintenance of files
  • Human readable data for 21 CFR Part 11 compliance by PDF export and print functionality
  • Better organization and categorization of data by tagging
  • Better data security and control of operations by user and password management
  • Controlled collaboration by sharing data with authorised group of users
  • Better tracking and easy trouble shooting by Audit Train
  • Complete access control of all applications including non-compliant by CFR gateway extension
  • Electronic data and electronic signature which are critical for 21 CFR part 11 compliance
  • Central secured data base and file server
  • Contemporaneous data capture

100% Data integrity can be ensured by implementing CFR Gateway solution which compliments Logilab SDMS in many ways particularly for non-compliant and non-standard systems and applications. Upon operating system boot, CFR gateway will be the first system that is loaded at startup. In this case, users need to necessarily login to gateway in order to access any other authorised applications. Any data created, modified or deleted by the user is fully tracked and sent to the server repository automatically. Even popular applications like word, excel, pdf, etc. can be used with high level of data integrity and version control.

Logilab SDMS ensures that users can verify the data that is captured from the instruments can go through a workflow process. Using the workflow tool users will be guided to follow the review and approval processes so that data errors can be avoided. 

 

Authorised users can place electronic signatures on appropriate records with the username, password and the reason with a date and time stamp is recorded. This will ensure that users can be fixed with the responsibility to carry out necessary checks during the data transaction process.

Scheduling certain type of files generated in Lab process using file type watcher. This will ensure filtering out of unwanted data or files.

 

Users can identify or provide additional metadata for instrument generated data by entering batch numbers, sample types, projects, sample ids.  This improves the accuracy of the data. The instrument data can be searched easily using the specific tag name.

 

The Scheduler can capture data generated by instruments automatically. It can be configured with respect to time. Live-capture module is used as and when data is generated being used by any other software.

 

The changes made to the files in the source will be captured with proper version control. Automated removal of files from local clients can be configured based on file deletion policy.

 

It is very easy to search (wider search criteria), view (using preview facility), retrieve and navigate the data (including all the versions) inside the SDMS Explorer which is similar Windows Explorer. SDMS Explorer is easily accessible by authorised personnel using role-based access control.  Also, data can be logically separated by creating multiple FTP storage systems.

Logilab SDMS supports easy readability of data in PDF format and printing. Human Readable data is also a mandatory process as per 21 CFR Part 11.

 

Whenever there is a report generated by an instrument software, users can store this report in a human readable format.  Logilab SDMS provides a virtual PDF printer. Once the users have finalised the data inside the instrument software, Logilab virtual PDF printer can be used to generate a human readable PDF format of the report and then send to printer for printing on a paper if required.

Audit trails module records each and every user & system action namely uploads, downloads Logins, Logoffs, failed logins, password policy, etc. Audit Trail has features to filter data based on user-based or module-based, time-based, type of audit trails. The audit trail settings are carried out only by Administrator users. Auditors can review specific audit trails and record/mark them. Audit trails can be exported such that Auditors can take them away as part of their audits.

 

The Audit Trail module records data with Time stamp, who did what and when and why at any point in time. Any communication failures that happen with respect to instrument are also audit-trailed inside the system.

Logilab SDMS has the functionality to configure Users, their access rights restrictions and password policies.

Logilab SDMS has got its own built-in security module where Admin Users will be able to create users, groups and provide rights for users to access various parts of the applications, functionalities of the application or only view the data. 

 

Also, password policies, which correspond to 21 CFR Part 11 and   Eudralex Annex 11 can be setup inside the Logilab Security module with full control over the access to functionalities and data.  This will ensure different operations will be performed based on the restrictions/privileges setup on the individual users as per company policies.

Logilab SDMS helps Laboratory users to achieve this by:

1) Attributable: Logilab SDMS captures instrument data along with meta data with information like which instrument, which user, on what data and at what time.

2) Legible: The data handled by SDMS is always electronic, easily accessible and human readable.

3) Contemporaneous: Data and meta data are captured and stored as and when generated (along with exact data and time stamp) and not the data generated at a different point of time. SDMS’s mobile capability further enhances as the user does not need computer (PC or desktop) but simply using mobile device.

4) Original/true data: Logilab SDMS helps users to e-sign the data and metadata as true and original

5) Accurate: Data capture is automated and there is no human intervention required in Logilab SDMS system. This is achieved by the heart of the SDMS system called ‘Data Scheduler’.

Logilab SDMS has an audit trail module which records each and every user & system action namely uploads, downloads Logins, Logoffs, failed logins, password policy, etc.  The Audit Trail module records data with Time stamp, who did what and when and why at any p