# CodonLIMS — Full Documentation > Laboratory Information Management System (LIMS) for pharmaceutical, biotech, stainless steel, automotive, mining, dairy, and manufacturing industries. GMP, GLP, and 21 CFR Part 11 compliant. Built by Codon Software Pvt Ltd. CodonLIMS is a configurable, web-based LIMS platform that helps laboratories manage samples, inventory, workflows, instruments, compliance documentation, and quality processes. It is not a turnkey system — it is a customizable, programmable system that adapts to each customer's specific laboratory workflows and requirements. --- ## Sample Management The Sample Management module provides end-to-end tracking of the sample lifecycle from receipt through testing to disposition. **Capabilities:** - Record the location of samples and their movement within and between laboratories - Full chain of custody tracking from receipt to disposition - Storage location tracking with visual monitoring to quickly locate specific samples - Live status tracking of sample progress through testing workflows - QC activity management linked to each sample - Sample login, labeling, and distribution - Result entry with specification checking - Automatic disposition based on test results **Use cases:** Pharmaceutical QC labs receiving batch samples, dairy labs tracking milk and product samples, metals labs managing material test specimens, mining labs tracking ore and assay samples, stainless steel labs managing heat samples, automotive testing labs tracking component test specimens, battery manufacturing labs managing cell and electrolyte samples. --- ## Inventory Management Tracks all laboratory consumables and manages stock levels automatically. **Capabilities:** - Track consumables, reagents, standards, reference materials, media, and equipment - Auto-add new batches to inventory upon receipt - Monitor minimum stock thresholds with automated alerts - Track lot numbers, expiry dates, certificates of analysis - Usage recording linked to specific tests and samples - Supplier and purchase order tracking **Use cases:** Reagent management in pharmaceutical QC labs, media inventory for microbiology labs, standard solution tracking, chemical reagent management for mining assay labs, consumables tracking for automotive testing facilities. --- ## Workflow Management Defines and enforces laboratory standard operating procedures through configurable workflows. **Capabilities:** - Define sample flow procedures with configurable steps - Flexible review and approval mechanisms - Route records to multiple approvers within the organization - Enforce step sequencing and prerequisites - Track workflow status and bottlenecks - Documented authorization with electronic signatures **Use cases:** Multi-level approval for OOS investigations, analyst review workflows, batch release processes. --- ## Instrument Integration Eliminates manual data entry by connecting laboratory instruments directly to the system. **Capabilities:** - LIMSinc bridge tool for direct instrument-to-system data transfer - Electronic tracking and auditing of all instrument data flow - Support for various instrument types and data formats - Instrument calibration tracking and scheduling - Service history and utilization reporting - Eliminates transcription errors from manual data entry **Use cases:** HPLC, GC, UV-Vis, pH meters, balances, dissolution apparatus, Karl Fischer titrators, OES (optical emission spectrometry), XRF (X-ray fluorescence), ICP (inductively coupled plasma), tensile testing machines, hardness testers. --- ## Stability Studies Manages ICH-compliant stability study protocols for pharmaceutical and food products. **Capabilities:** - Configure shelf-life protocols with defined timepoints - Apply tests at various storage conditions (temperature, humidity) - Track samples across multiple stability chambers - Generate stability trend reports and graphs - Alert on upcoming pull dates - Support for accelerated, intermediate, and long-term studies - ICH Q1A compliant protocol management **Use cases:** Pharmaceutical stability testing per ICH guidelines, food product shelf-life studies, API stability programs, battery cell aging studies, material durability testing under environmental stress. --- ## e-Lab Notebook (ELN) Electronic laboratory notebook for capturing experimental procedures with improved data quality. **Capabilities:** - Structure editor for chemical and molecular structures - Free-flow drawing editor for diagrams and sketches - Rich text document editor for narrative documentation - Search by projects, tests, chemical formulas, analysts, instruments, or text - Instrument connectivity and service tracking with utilization reporting - Excel to PDF migration and trend graph generation - Role-based access with individual user data security - Audit trails meeting 21 CFR Part 11, GMP/cGMP/GLP regulations **Specialized Applications:** - **API Development**: Group experimental data by researcher, track drug compound history, design conceptual experiments before synthesis to reduce solvent use and cycle times - **Formulation**: Built-in recipe editor and analytical data repository, automatic calculation modules for ingredient adjustments, quick access to existing formulations - **Biologics Research**: Experiment design across upstream/downstream processing and analytical stages with secured data transfer between process labs **Use cases:** R&D lab notebooks, method development documentation, formulation experiments, biologics process development. --- ## Barcode and RFID Built-in identification system for tracking laboratory items. **Capabilities:** - Built-in barcode generator with customizable label formats - Support for 1D and 2D barcodes - RFID tag support for high-throughput environments - Sample identification and tracking - Inventory item labeling and scanning - Reduces manual record-keeping time and labor costs **Use cases:** Sample labeling at receipt, reagent bottle tracking, equipment identification, storage location labeling. --- ## Training Management Comprehensive training administration for laboratory personnel compliance. **Capabilities:** - Document mandatory SOP, cGMP, safety, and environmental training - Automated email and SMS alerts for upcoming and overdue training - E-course creation and delivery within the system - Multiple Choice Question (MCQ) assessments with scoring - Audit-ready training reports and certificates - Training matrix by role and department - Re-training scheduling and tracking **Use cases:** Annual cGMP training, new SOP training rollout, analyst competency assessments, regulatory audit preparation. --- ## Supplier Validation Manages vendor qualification to ensure quality of incoming materials. **Capabilities:** - Compare qualification results across multiple suppliers - Track raw material, inventory, and instrument supplier qualifications - Pre-procurement verification workflows - Supplier audit tracking and scheduling - Certificate of Analysis verification - Approved supplier list management **Use cases:** Raw material vendor qualification, instrument service provider evaluation, reference standard supplier management. --- ## Microbiology Lab Management Specialized module for microbiological testing laboratory operations. **Capabilities:** - Culture and media preparation record keeping - Design and report microbial tests - Growth promotion testing - Sterility testing workflows - Water testing (purified water, WFI) - Microbial counts and identification - Environmental monitoring integration - Media fill studies support **Use cases:** Pharmaceutical microbiology labs, water testing facilities, sterility testing, environmental monitoring programs. --- ## OOS (Out-of-Specification) Management Automated handling of out-of-specification test results per FDA guidelines. **Capabilities:** - Auto-notification when results fall outside specification limits - Flexible investigation workflows - Resampling option with documented justification - Re-analysis option with root cause documentation - Re-assignment option for alternative analyst review - Investigation tracking with timelines - CAPA integration for corrective actions **Use cases:** Pharmaceutical batch testing OOS events, stability study OOS results, raw material testing failures, steel composition out-of-spec results, mining assay failures, battery cell performance deviations. --- ## OOT (Out-of-Trend) Management Statistical trend detection to identify unexpected patterns before they become OOS events. **Capabilities:** - 3-sigma modeling for trend detection - Regression analysis against historical data - Automatic comparison with historical patterns - Alert generation for identified trends - Investigation workflow integration - Trend reporting and visualization **Use cases:** Stability data trending, process monitoring, equipment performance tracking, water system trend analysis, steel heat trend analysis, mining grade trending, battery cycle life trending. --- ## External Systems Integration Connects CodonLIMS with other enterprise systems and external parties. **Capabilities:** - Data transfer to production departments - Integration with external laboratories - ERP system connectivity (SAP and others) - Certificate of Analysis (COA) generation and distribution - Secure cross-platform result sharing - API-based integration options **Use cases:** SAP integration for batch release, sharing results with contract labs, COA generation for customers, mill test certificate generation for steel manufacturers, assay reports for mining operations. --- ## Environmental Monitoring Monitors environmental conditions across manufacturing and laboratory facilities. **Capabilities:** - Capture monitoring parameters across plant locations - Track temperature, humidity, particulate counts, and other parameters - Generate precautionary action reports - Trend analysis for environmental data - Alert generation for out-of-limit conditions - Integration with facility monitoring systems **Use cases:** Cleanroom monitoring, warehouse condition tracking, stability chamber monitoring, production area environmental control. --- ## Resource Booking Calendar-based reservation system for shared laboratory resources. **Capabilities:** - Calendar-based scheduling for equipment, rooms, and facilities - Utilization dashboards showing resource usage patterns - Conflict detection and resolution - Recurring booking support - Reduces administrative overhead for reservation management **Use cases:** Shared instrument booking (HPLC, NMR), meeting room reservations, calibration lab scheduling. --- ## Storage Locations Visual management of laboratory storage infrastructure. **Capabilities:** - Multi-level hierarchy visualization: locations, components, shelves, racks, positions - Track item arrival, placement, movement, and expiration - Environmental attribute monitoring per storage location - Visual map of storage occupancy - Quick search and locate functionality **Use cases:** Sample storage management, reagent warehousing, stability chamber organization, cold room inventory. --- ## Measurement of Uncertainty Captures and reports measurement uncertainty per ISO 17025 requirements. **Capabilities:** - Per-instrument measurement uncertainty data capture - Final uncertainty ranges displayed alongside test results - Supports various uncertainty calculation methods - Integration with instrument calibration data **Use cases:** Accredited testing labs, ISO 17025 compliance, customer-facing test reports with uncertainty values, metals analysis labs, mining assay labs, automotive testing facilities. --- ## Compliance and Regulatory CodonLIMS is designed to meet stringent regulatory requirements for regulated industries: - **21 CFR Part 11**: Electronic records and electronic signatures, audit trails, system access controls, authority checks - **GMP / cGMP**: Good Manufacturing Practice compliance for pharmaceutical and food industries - **GLP**: Good Laboratory Practice compliance for non-clinical testing - **Full audit trail**: Every data modification is recorded with timestamp, user, old value, and new value - **Role-based access control**: Granular permissions with individual user data security - **Electronic signatures**: Authenticated signatures with meaning (reviewed, approved, rejected) - **Data integrity**: ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) --- ## Industries and Applications ### Pharmaceutical Manufacturing - Quality Control (QC) laboratories: Batch testing, raw material testing, finished product testing - Quality Assurance (QA) departments: Batch release, deviation management, CAPA tracking - Research and Development: Method development, formulation, API characterization - Stability testing: ICH-compliant stability study management - Microbiology: Environmental monitoring, sterility testing, water testing - API development: Synthetic route tracking, compound history ### Biotech - Biologics research: Upstream/downstream process development, analytical method management - Cell culture monitoring and fermentation process tracking - Protein characterization and purity testing - Process analytical technology (PAT) integration - Biosimilar development and comparison studies ### Stainless Steel Manufacturing - Chemical composition analysis: OES, XRF, ICP testing for alloy verification - Mechanical testing: Tensile strength, hardness, impact, bend testing - Heat analysis and heat-wise sample tracking - Product certification and mill test certificate (MTC) generation - Incoming raw material inspection and verification - Metallographic analysis and grain structure evaluation ### Automotive Testing - Material testing: Component material verification and certification - Environmental testing: Temperature cycling, humidity, vibration, corrosion testing - Reliability testing: Endurance, fatigue, and accelerated life testing - Compliance certification: ISO/TS 16949, IATF 16949 testing documentation - Component and sub-assembly quality testing ### Car Battery Manufacturing - Raw material testing: Cathode, anode, electrolyte, separator material analysis - Electrolyte composition and purity analysis - Cell performance testing: Capacity, voltage, impedance, cycle life - Safety testing: Thermal abuse, overcharge, short circuit, crush testing - Quality control: In-process and finished product testing - Environmental and aging studies for battery cells ### Mining — Multi-Commodity - Ore grade analysis and assay management (gold, copper, iron, nickel, zinc, etc.) - Exploration sample tracking with geological context - Geochemical analysis and multi-element testing - Environmental compliance monitoring: Water, soil, air quality testing - Process plant laboratory: Flotation, leaching, and recovery testing - Tailings and waste characterization ### Mining — Coal - Proximate analysis: Moisture, volatile matter, ash, fixed carbon - Ultimate analysis: Carbon, hydrogen, nitrogen, sulfur, oxygen - Calorific value (gross and net) determination - Ash fusion temperature testing - Sulfur analysis and forms of sulfur - Coal washability and preparation plant testing - Environmental monitoring: Dust, water quality, emissions ### Dairy - Milk quality testing: Fat, SNF, protein, lactose, adulteration testing - Product composition analysis for cheese, yogurt, butter, and milk powder - Microbiological testing: Total plate count, coliform, E. coli, Salmonella - Shelf-life studies and stability testing - Water quality testing for processing facilities ### Metals & Materials - Material composition analysis: OES, XRF, ICP for alloy identification - Mechanical testing: Tensile, hardness (Rockwell, Brinell, Vickers), impact (Charpy, Izod) - Metallographic analysis: Microstructure, grain size, inclusion rating - Incoming inspection and vendor qualification testing - Certification testing for customer-facing test reports and COAs --- ## Technical Details - **Platform**: Web-based application, accessible from any modern browser - **Deployment**: On-premise or cloud deployment options - **Device Support**: Desktop, tablet, and mobile browsers - **Architecture**: Customizable and programmable — not a fixed turnkey system - **Integration**: LIMSinc bridge for instruments, API for ERP and external systems --- ## Company Information - **Product**: CodonLIMS - **Company**: Codon Software Pvt Ltd - **Product Website**: https://codonlims.com - **Company Website**: https://codonsoft.com - **Contact Email**: info@codonsoft.com - **General Inquiries**: hello@codonsoft.com - **Request a Demo**: Visit https://codonlims.com and click "Request Demo" - **Download Brochure**: Available on the CodonLIMS homepage ### Usage Statistics - 225+ active users - 15 customer organizations - 2 countries - 9+ industry verticals (Pharmaceutical Manufacturing, Biotech, Stainless Steel Manufacturing, Automotive Testing, Car Battery Manufacturing, Multi-Commodity Mining, Coal Mining, Dairy, Metals & Materials) ### Other Products by Codon Software - **CodonQMS** (https://codonqms.com): Quality Management System - **docuHive** (https://docuhived.com): Enterprise Document Management System - **CrewMetrics** (https://crewmetrics360.com): Workforce Management Platform - **retailTrac** (https://retailtrac360.com): Retail Financial Management - **ServiceTrac** (https://servicetrac.com): Service Management Platform - **ezPOZ** (https://ezpoz.com): Point of Sale System