About Qualis LIMS ? Why Qualis LIMS Software ?

Qualis LIMS

Designed for QA/QC Analytical Laboratories.

Qualis LIMS, Agaram's Out-of-box Laboratory Information Management System, fits across industry verticals with specialised focus for Quality Control and Research Centers with features for Regulated industries

INDUSTRIES

Pharmaceutical

Drug Discovery

Clinical Research

Food & Beverage

Chemicals

Metal & Mining

Oil & Gas

Environmental

Contract Research Organizations (CRO)

Forensics

Agriculture

Bio-Banking

About Qualis LIMS

Qualis LIMS is designed for use in any industrial analytical laboratory and commercial labs testing samples. It provides a structured method to document the laboratory investigations besides handling the compliance requirements.

The various steps involved in the whole process like Test and Specification Management, Ordering of Tests, Registration of Samples, Job Allocation, Results Entry and Approval, Report Generation, Out of Specification (OOS), Deviation Recording and Document Management functions are comprehensively managed by Qualis LIMS

Qualis LIMS Features

Unified and easy to use Test and Specification Management System

Test Masters with relevant attributes and parameters can be maintained based on test category and specific sections within the laboratory that will perform the tests. This will help to keep track of vital attributes of testing.

Tests can have one or multiple parameters

Parameters can be numeric, character, pre-defined values, attachments etc.

Tests can be linked to instruments, have rounding rules and analysis techniques, which in Manages one or more material for each specification

turn are linked to user/personnel and training records

Provide several layers of hierarchy for quick access and easy maintenance as shown below Material > Group > Sub Group > Profile > Specification Version > Tests > Parameters > Limits.

Document upload for each specification

GLP Principles, ISO17025 and regulatory standards compliance - Easy to use Instrument and Equipment Management System

Qualis LIMS Instrument Management module helps to maintain all instruments and equipment’s used across the laboratory. This will ensure adherence to Good Laboratory Practices, Regulatory Standard Compliance and lead to improved quality results.

Determine and maintain the status of the Calibration and maintenance instrument. Generate alerts through scheduler

Generate calibrated samples automatically. Record and document each and every calibration.

Ensures that only calibrated instruments can be assigned for tests and goes through a

workflow for approval.

Keep track of Material used in Labs - Better Standardised Material Management system

Qualis LIMS maintains a complete material inventory of the laboratory. This allows the laboratory to track and account of the material consumption, manage the expiry dates and ensure correct material usage.

Provides categorization of material

Maintain masters for all types of standards, volumetric solutions, reagents, chemicals, glassware, etc.

Document and Track Input Reference Standard No., Batch #, Lot #, Qty., Unit, Expiry date, Storage condition, Purity, ROL, Open expiry days, etc.

Improve reliability and Quality Results by Training and Analyst Certification process

Qualis LIMS Competence management allows to schedule training programs, invite participants and record the participants’ progress. Reliability and quality results can be improved by assigning trained persons to the laboratory jobs, thus ensuring GLP principles compliance.

Links training with analytical technique and instrument category. Competency types (competent, certified, unskilled, for example)

Assign competent individuals to specific tasks.

Maintains training status of individuals.

Error free, reliable data handling by across the Lab- Barcode Labelling

Qualis LIMS supports barcode label generation that is generated upon sample registration which will ensure faster recording of data, ease of operations, minimize errors and improve reliability

Helps to quickly identify result records, jobs etc. within the application

Easily record chain of custody.

Users can design their own templates and have their label size with related sample information. Compatible with any barcode scanner or printing device.

Quick and Efficient Sample Registration

and Test Ordering

Sample Registration in Qualis LIMS begins with Chain of Custody which helps to keep track of the sample throughout its life cycle.

Allows the samples [Raw Material, Intermediate and Finished Product] to register manually

Automated Sample registration via file import and scheduler.

Generate Unique Sample Number or an Analytical Request Number (AR Number)

Appropriate profile and specification selection for each sample.

Helps to set Testing priorities for samples.

Increases Productivity by having Resource/Job Allocation Module

Qualis LIMS Job Allocation module enables allocation of tests, instruments and personnel for samples. This enhances productivity, saves times and better control and monitoring of human resources in labs.

Authorized user/supervisor can allocate an available and certified analyst to perform a specific test. More than one analyst can be allocated per test with split job responsibilities.

Schedules job based on Analyst or Instrument Calendar.

Scheduler display existing allocation of samples/tests for each analyst and workload of each instrument

defined in the laboratory.

Job allocation is linked to personnel training records and certified personnel can be allocated to jobs. User/Supervisor has complete control over the instrument usage and jobs allocated to specific analysts.

A graphical chart displays a complete picture of the lab workload given to an analyst. Provides easy and quick option to Reschedule jobs

Quick Result Entry

Qualis LIMS Result entry module allows certified analysts to enter test results manually based on a sample number and test. The module provides great flexibility and makes it easy for users to track the entries

Automated result entry is provided via file import.

Final results along with the instrument used with its identifier, usage time, and calibration status with test execution can be linked.

Attach raw data and reports from the instrument for each test.

Records and maintain status for Complete traceability of results

Helps regulated laboratories to eliminate additional work, improve e ciency and be audit ready.

Ensure Data Integrity compliance of GLP principles by providing Interfaces

Integration capability of Qualis LIMS with Logilab SDMS (Scientific Data Management System) and Logilab ELN (Electronic Lab Notebook) ensures contemporaneous data capture from instruments which is very critical in adhering to Data Integrity compliance principle of GLP

Possible to manually enter data and perform calculations in real time.

Seamlessly Interface with any analytical instrument to capture data automatically.

Easy configuration

No additional software programming, coding or vendor dependency.

Workflow - achieve better monitoring, control and improve quality of results

In order to achieve better monitoring, control of the processes as well as to achieve better quality results, Qualis LIMS has in-built approval workflow which can be configured to achieve

Multiple levels of approvals. Check individual test results, calculations performed, raw data captured etc. Request a re-test/re-calculation.

Reports & Dashboards – Critical information and alerts to users for proactive

steps

Qualis LIMS has a dedicated reporting module with pre-packaged set of commonly used reports. The reports and dashboard functionality provides critical information for users to be proactive. It ensures that key decisions are made with the right information at the right time. KPIs can be monitored easily using dashboards and reports.

Allows the user to generate reports as pdf files, Lookup previously generated reports based on specific criteria. Ad-hoc reports can also be generated and be made available to the users. Reports can be emailed to the appropriate users or client contact.

Comprehensive and Complete Audit Trail

What was changed (the field and table that was modified)?

When the change was made (the time and date)?

Who made the change (the user name of person logged at the time of change)?

Why it was changed (the reason for modification)?

Contains Previous and New Values.

Maintains separate log for system generated entries and user generated entries.

Regulatory Compliance

21 CFR Part 11 Compliance

ISO 17025

Audit Trail for complete traceability

Electronic Signature

Secured Login Validation Support

GXP Features

Eudralex Annex 11

Better security and control of operationsUser Management & Password Policy

Qualis LIMS has a full-fledged user access, roles and rights management.

Access to specific screens and controls

Creates unique Login ID

Assign multi role for a user

Deputy user

Role-based password policy

Locks account on failed password attempt

Password Expiry Policy

Session Lockout

Easy data segregation - Project Management

Qualis LIMS Project management helps to track the laboratory task based on the projects. A Project Manager can track the following:

Test involved

Budget of the project

Duration of the project

Resource involved

It helps in identifying the cost, schedule and performance risk. Project management module has the functionality to

Assign project team members to a Project to secure the access

Project can be assigned to tests and specification

Price can be assigned to test involved in the project and can be version-controlled

Contact Us

Agaram Technologies Private

Limited

Priyan Plaza, 76, Nelson Road, Aminjikarai, Chennai 600 029, INDIA

T: +91 44 4208 2005

T: +91 44 42189406

E: info@agaramtech.com

W: www.agaramtech.com

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