Qualis LIMS

Qualis LIMS is a configurable, compliance-ready Laboratory Information Management System developed by Agaram Technologies, designed to unify laboratory operations into a secure, paperless, and cloud-based environment. It covers the full sample lifecycle from receipt and registration through testing, approval, and final report delivery. Built for QC, R&D, healthcare, and commercial testing labs, Qualis LIMS is industry-agnostic and supports organisations in pharmaceutical, life sciences, food safety, environmental, clinical diagnostics, and chemical manufacturing sectors.

The platform is engineered to meet stringent regulatory requirements including 21 CFR Part 11, EudraLex Annex 11, ISO 17025, GLP, and GAMP 4, while delivering measurable operational improvements such as 30% higher productivity through automated workflows, 40% faster audit readiness via full data traceability, 40–60% fewer transcription errors, and up to 70% faster sample testing throughput.

Flexible Sample Registration and Testing

• Register and test any sample type including raw materials, finished products, patient samples, clinical trial specimens, and R&D project samples.
• Dynamic sample registration templates with drag-and-drop field configuration.
• Version-controlled template management to ensure data integrity.
• Full sample lifecycle tracking with complete metadata capture.

Unified Test and Specification Management

• Create and manage multiple test groups for samples based on test parameters.
• Manage test specifications with version control and release control to maintain traceability.
• Define test specifications by setting limits based on expected test results.

Live Dashboards and Alerts

• Real-time KPI dashboards providing comprehensive operational visibility.
• Automated alerts for approvals, calibration due dates, job assignments, and non-conformance events.
• Customisable, role-based views tailored for managers, analysts, and QA personnel.

Job Allocation to Certified Personnel and Qualified Instruments

• Allocate tests, instruments, and samples to specific laboratory personnel.
• Assign role-based tasks to lab staff for performing specific tests.
• Ensure that only certified personnel are allocated to specific jobs or techniques.

Standardised Inventory Management

• Maintain multiple categories of inventory material with barcode labelling.
• Record and track usage of inventory materials in real time.
• Create dynamic storage structures for organising and optimising material storage.

Instrument and Equipment Management

• Maintain records of all instruments and equipment used across the laboratory.
• Track validation, calibration, and maintenance logs for each instrument.
• Ensure that only calibrated instruments can be assigned for testing activities.

Automated Result Entry and Reporting

• Design custom report templates using a built-in reporting tool with an auto-generate SQL query builder.
• Approve and release reports rapidly using electronic and digital signatures.
• Make reports available to external stakeholders through the Qualis Portal.

Compliance and Audit-Readiness

• Designed with ALCOA+ principles, comprehensive audit trails, and role-based access control.
• Supports inspection readiness for FDA, EMA, NABL, and ISO audits.
• Pre-validated modules and audit-ready features reduce the cost and effort of compliance.
• Electronic record integrity and granular access controls safeguard data at all times.

Industries and Use Cases

• Pharmaceutical QC and QA: Batch release, finished product testing, stability studies, CAPA tracking, deviation documentation, and data integrity compliance.
• Healthcare and Clinical Diagnostics: Patient sample tracking with full chain-of-custody, integration across hospital and diagnostic networks, and automated data exchange.
• Life Sciences Research: Centralised management of research data, sample metadata, and assay tracking with multi-site collaboration and version-controlled documentation.
• Food Safety and Quality Testing: Ingredient traceability, microbial and chemical QC testing, and regulatory compliance documentation.
• Environmental and Water Testing Labs: Field-to-lab sample management, contaminant monitoring, and adherence to local and international environmental standards.
• Chemical and Industrial Manufacturing: GLP-compliant QC testing, deviation and CAPA management, process validation, and data-driven quality improvement.

Key Platform Capabilities

• Web-based and platform-independent, compatible with Chrome, Firefox, Safari, and other browsers.
• Highly scalable across multi-site, multi-department, and multi-lab environments.
• No-code configurability allows workflows to be tailored without programming.
• Complete workflow automation from sample registration through to report release.
• Faster turnaround time supported by automated alerts, dashboards, and high-throughput sample testing.

Qualis LIMS can be deployed on AWS, Azure, customer-owned private cloud, or on-premises infrastructure, offering flexibility for organisations of all sizes. It integrates with Agaram's broader product ecosystem including Logilab ELN, Logilab SDMS, and Qualis DMS, and connects to laboratory instruments via RS232 and TCP/IP protocols through the Interfacer middleware.