#1 Software to meet ALCOA & Data Integrity for regulated industries

Single source of truth for instrument raw & meta data and controlled documents
data integrity in pharmaceutical industry

About Logilab Scientific Data Management System (SDMS)

Logilab SDMS is a mature and proven Scientific Data Management System designed, developed, implemented and supported by Agaram Technologies, a leading software solutions provider in the area of laboratory informatics.

It has been designed mainly to

  • Capture, Catalog and Archive instrument raw data and files
  •  Metadata along with a human readable data
  • Tags data in a manner such that data can be indexed into catalog and archived for long term purposes


It is a new kind of generic enterprise class scientific data management software solution designed to capture data from any analytical instrument (i.e. PC-software-based as well as standalone non-pc-based ones with ports of TCP/IP, RS232 and analog), irrespective of type, make and manufacturer.

Instrument Data as well as metadata can be captured and archived to a secure and dedicated server which acts as a single point of truth.

Logilab SDMS is a secure file-storage system. It stores all the files in an FTP server in a secure manner and any metadata related to the files are stored in a central database server.
Logilab SDMS has been designed for integrating external systems like LIMS, ERP and Electronic Notebook (ELN) Systems. There are appropriate middleware tools available for integrating external systems through the Logilab SDMS system interface.

Data access and viewing are controlled through user rights ensuring data security. The metadata like instrument/user source, data/time, file size, checksum and user-entered tags along with the parsed and extracted data are stored in a central database repository. Full text indexing allows strong search facility and ensures the availability of required data instantaneously.

It can be easily implemented as cloud software for laboratories.

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Necessity of SDMS software system for Regulated Industries

  • Regulated industries are mandated to properly store raw and metadata generated by instruments and must be in a human-readable format and be retrievable securely.
  • Data used for GMP and GLP compliance facilities must be available in a controlled and secured repository and must be able to be audited at any time by internal and external regulatory bodies
  • The data must be maintained as a single source of truth as mandated by ALCOA principles of data integrity
  • Ability of the cGMP facilities to exhibit US FDA’s 21 CFR Part 11 regulatory compliance and EU’s Eudralex Annex 11 standard compliance

 

A controlled secured environment:

  • Must be readily available 
  • Data must be Version controlled whenever modified
  •  True copy of the original data must be available
  • Data must be in human-readable format
  • Data must be able to be tagged with meta data
  • Data must be able to be stored, archived and retrieved on long term basis

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data integrity in pharma

What makes Logilab ELN, one of the best ELN Softwares in the market?

  • Versatile Data Capture – Any instrument data of any format including PC-Based, RS232, TCP/IP and analog output
  • Full automated secure file handling by SDMS Scheduler with file version control
  • Easy Navigation, Secure, Faster and Wider search by Data Explorer
  • Human-readable Data to comply with US FDA’s 21 CFR Part 11 regulation – By PDF view, download and print functionality
  • Better organization, categorization and standardization of data – By Tagging and Templates functionality

  • Better security and control of Operations – By user Management and Password policy setup
  • Controlled sharing of data with colleagues and partners
  • Integration capabilities with other external systems namely ERP, LIMS and ELN
  • User-defined logical separation of data like QC, Research, QA, etc.
  • Better Tracking and Easy Trouble-shooting – By Audit Trail
  • Easy extraction of data of interest – By Parsing Engine
  • Complete access control of all applications including non-compliant ones – By CFR Gateway module extension
  • Electronic signature capability – 21 CFR Part 11 compliance
  • Mobile usability to contemporaneously record data – By SDMS Mobile application module

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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.

Logilab SDMS – Purchase and Implementation Options

Logilab SDMS is licensed based on the number and type of instruments

 On-premiseCustomer-owned cloudAgaram-Hosted and Managed Cloud-based Saas*
Perpetual Licence✔️✔️✔️
Saas Subscription----✔️
  •  Logilab SDMS will be implemented with SaaS model on Agaram-hosted managed cloud environment. It can be accessed from any web browser using thin clients such as laptops, tablets, and smart phones.
  • This facilitates real-time collaboration amongst laboratories located across many places internationally.
  • Cloud-based SDMS eliminates the need of huge investment in constructing IT infrastructure and hiring of trained personnel.
  • Cloud-hosting of SDMS enables quick, easy and cost-effective deployment in a secure, reliable and highly available environment.

Benefits of Logilab SDMS

  • Improved reliability, consistency in operations and low cost of compliance  due to 100% automated adherence to data integrity, Eudralex Annex 11 standard and 21 CFR Part 11 regulatory compliance
  • Error-free results due to automated data capture from Instruments and user systems
  • Simple and easy-to-use User Application Interface provides best user experience and user confidence
  • Globally accessible, scalable to multi-sites increases ease and time of implementation
  • Time savings from operational perspective due to automation of tasks
  • Cost savings in terms of paperless automated transactions
  • Low cost of ownership due to standard technology architecture
data integrity pharmaceutical industry
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