Comprehensive Solution to digitally transform Laboratory Processes

Comprehensive solutions to digitally transform the entire Laboratory processes which helps in minimizing manual errors and increase the accuracy in maintaining the Laboratory Analysis data/records. The solution has been successfully running through various regulatory agency audits such as FDA, USFDA, MHRA, UNICEF, TGO, etc.

Regulatory Requirements

  • Complete Access Control Management covering User creation/disable, Password Policy, Group Privileges, Password Reset etc..
  • Comprehensive Audit Trail which record each & every activity
  • Inbuilt maker/checker arrangement with complete audit trail facility
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Solution Features

Sample Management – Complete Sample Tracking System
Status Label Generation – Under Test, Pass / Reject, Sample For Analysis, Approved, Various Checklists with A.R. No / Batch affix, re-print control etc..
QC Testing – Comprehensive Analysis Process for Raw Material , Packaging Material , Finish Product , Stability Sample, Volumetric Solutions
Volumetric Solution – Scheduling, Complete Tracking from TDS To ATR
Digitized Logbook – Complete usages solution for Instrument, Columm, A.R. No. / Sub A.R. No. etc..
Laboratory Standard – Complete stock, issuance, usages solution for All Type of Standards
Reserve / Control Sample – Comprehensive Sample Registration to Destruction including withdrawal & visual inspection/verification Process
Stability Management – Batch Record, Scheduling, Pullout, Result Process including Stability test report, pullout log, trend analysis & labels – Read more…
Software facilitate with advanced search and trend analysis which help to track records more easily and faster manner
Minimal data entry process via multiple single time masters like Instruments / Test Names / Product Names / Grades
Facility to Trace open events and monitor all associated actions

Solution Key Benefits

  • Software maintain comprehensive records that enable companies to innovate faster, run labs more efficiently, improve manufactured product quality, achieve accurate record keeping and comply with regulatory requirements.
  • Complete evidence of validation execution includes Installation Qualification, Operational Qualification, System Security, 21CFR Checklist, Risk Assessment, Backup Restore Validation, Disaster Recovery
  • Help avoiding manual data entry by connecting various instruments to maintain usage logs
  • Facilitate to implement core functionality across sites, which helps to establish uniform quality practices within the organization
  • Easy software access through PC’s, Laptop’s and Tab’s