Logilab BES

Logilab BES (Bioanalytical Execution System) is a purpose-built software solution from Agaram Technologies, specifically designed for BA/BE (Bioanalytical/Bioequivalence) and DMPK laboratories. It enables a controlled, paperless environment that ensures compliant, error-free, and fully traceable bioanalytical workflows, helping clinical research organizations accelerate study execution while maintaining the highest standards of data integrity.

Logilab BES is built to elevate accuracy, speed, and control across all BA/BE lab operations — from method development and protocol execution through to batch validation, trend analysis, and audit preparation. The system delivers measurable performance improvements, including a 45% reduction in batch review cycles, 55% faster method development and validation, 60% fewer manual data entry errors, and 70% less time spent on audit preparation.

Method Development & Validation

• Develop and execute methods using spreadsheet or protocol-based templates, capturing data for lab and process development tasks
• Capture chromatography settings, extraction procedures, and validation data seamlessly within the system
• Maintain version control for both labsheets and protocols to preserve data integrity and traceability
• Validate methods for a range of tests including ruggedness, dilution integrity, linearity, accuracy, and more using automated templates

Protocol Execution Made Digital

• Execute step-by-step protocols for sample preparation, standard/QC preparation, and instrument runs
• Enforce SOP compliance through interactive execution and real-time deviation capture
• Capture environmental conditions such as temperature and humidity in real-time within pre-defined fields

Batch Validation & Acceptance

• Streamline batch-wise data capture, validation checks, and review across multiple runs, analysts, and instruments
• Monitor batch acceptance and QC/CC trends with built-in calculations and visual PASS/FAIL indicators
• Link raw data and outputs from LC-MS/MS and other instruments directly to batch records

Trend Analysis – Powered by Microsoft Power BI

• Track Incurred Sample Reanalysis (ISR) and ISTD variations using interactive trend charts
• Analyze assay performance, recovery rates, and QC results across multiple batches
• Detect anomalies and drift early to support continuous improvement initiatives

Inventory, Stock & Equipment Management

• Create dynamic fields to record inventory metadata, configure inventory repositories to track usage and expiry, and set automatic alerts for low stock
• Create material hierarchies by associating samples and materials, and track the entire lineage of each sample
• Track and perform equipment calibration and maintenance, activate or deactivate equipment, and review transaction history

Data Traceability

• Link QC results and instrument files to respective samples and time points
• Maintain traceability across analytical runs with audit-ready metadata
• Minimize transcription errors with auto-populated data and perform live calculations for QC checks, %CV, %Diff, batch validation, and more

Compliance & Audit-Readiness

• Develop and execute methods with full version and release control
• Complete traceability of both instrument-generated and manually entered data
• Comprehensive audit trails with date- and time-stamped records of all user and system-generated actions
• Role-based access control and configurable review workflows enable secure, permission-based data handling and approvals in regulated workflows
• Supports compliance with 21 CFR Part 11, EU Annex 11, WHO, NABL, and GCLP guidelines

Seamless Instrument Integration

• Integrates with LC-MS/MS, HPLC, balances, centrifuges, and other instruments, capturing real-time data into structured templates
• Out-of-the-box compatibility with Excel and Word
• Connects with any file-based or standalone analytical instrument
• Supports RS232/TCPIP port-based instrument connectivity
• Integrates with Qualis LIMS and Logilab SDMS
• REST API available for integration with external systems

Key Benefits at a Glance

• End-to-End Traceability: Tracks every sample, batch, and data point across the study lifecycle
• Centralized Study Documentation: Organizes lab records by study, analyte, or timepoint for fast, configurable access and simplified audits
• Accelerated Workflow: Speeds up method development, protocol execution, and reporting through standardized workflows and automation
• Audit-Ready & Compliant: Meets requirements under 21 CFR Part 11, EU Annex 11, WHO, NABL, and GCLP guidelines

Logilab BES is developed by Agaram Technologies and is part of a broader suite of laboratory informatics products that includes Qualis LIMS, Logilab SDMS, Logilab ELN, and Qualis DMS. The system is designed to help labs transition smoothly from legacy paper-based or Excel workflows to a fully digital, compliant environment with minimal disruption.