Automated Data Integrity

Logilab® SDMS is a completely non-intrusive software for laboratories in the regulated industry to achieve data integrity (ALCOA) and 21 CFR Part 11 compliance. It provides authorized access to data, audit trail and version control.

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How Logilab SDMS helps Laboratories to enable GLP Compliance Part 2 of 4
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Data Integrity

Maintain data integrity in QC, R&D and process areas based on ALCOA.

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Compliance

Create a single source of truth and enable 21 CFR Part 11 compliance for entire lab.

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Integration

Integrate with any ELN/LIMS. Extract meaningful data and export to ELN/LIMS.

Designed for Compliance

Logilab SDMS’s automated capabilities capture data generated by any type of instrument, with minimal intervention required by users.

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Data Backup

  • Capture raw data or meta-data by any instrument
  • Store the data in secure FTP storage.
  • Backup securely with de-duplication technology.

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Tagging

  • Tag relevant data manually or automatically
  • Create hierarchy and non-hierarchy template.
  • Tag and lock instruments before data capture

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Traceability

  • Audit trail for all of the activity
  • Get workflow history for each data
  • Fault tolerant queue mechanism.

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CFR Gateway

  • Make non-compliant instruments comply with 21 CFR Part 11
  • Use single piece of software for instruments and data files
  • Use Gateway to provide controlled access to software

Key Features

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Automatic Scheduler

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File Transfer Protocol

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RS232, TCP/IP Instruments

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User Authentication

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E-Signature

What Our Customers Are Saying

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The LIMS provided by Agaram Technologies is now a well-established part of our official control authority batch release process and is used to record the testing of dozens of batches of vaccines and blood samples every day.

Ian Feavers
Professor
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"We are extremely satisfied with the product, implementation services, and post-implementation support delivered to us by Agaram Technologies. We have about 200 users in our lab; the product has been performing pretty well all these years."

Jay Singh
Analytical and Research Division Head

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The Enterprise Level Data Integrity Automation Solution

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How Logilab SDMS helps Laboratories to enable GLP Compliance Part 2 of 4