Toshvin is a leading supplier of Analytical Instruments in India. We represent Shimadzu Corporation, Japan for their wide range of analytical instruments.
Informatics Solutions
LabSolutions iLIMs(LIMS, QMS, DMS, eBRM)
CLASS (Complete Lab Aggregator Software System)
Simplified automation and compliance with “Sample Registration – Instrument Connectivity and Sample Dossier”
Features of CLASS
- Web based application (Server based)
- Collects data from non-PC based systems (port based) systems via RS232
- Can be configured with
- Standalone database compliance systems
- Server Database CDS systems like Empower, Chromeleon, LabSolutions
- Collects sample and non-sample information
- Instrument registration with optional instrument management
- Simple calculations
- Optional e-Dash Board
Adheres to 21 CFR Part 11 compliance
- Audit trails of all transactions with date and time stamp
- Role based access controls
- Electronic signature
- Storage of E-records in database
Sample Analysis
- Defining sample data structure
- Sample login with sample metadata
- Sample assignment and work allotment
- Transfer of method, batch and report to server
Reports
- Standard Report (report template, order of columns)
CaliberiLIMS
Pharma Ready Application with Fixed workflows for Sample Management, Instrument Management and upgradable to Standard LIMS
Caliber iLIMS is the right solution for analytical, development, and QA/QC manufacturing operations for small and medium industries. It's a seamless integration of sample workflow with different types of lab instruments and different type of CDS such as Shimadzu LabSolutions CS, Waters Empower and Thermo Chromeleon systems. This quality management framework manages your complete laboratory process lifecycle. Caliber iLIMS provides a complete functional framework for your current and future laboratory informatics and addresses all needs of Sample Management, OOS (Out of Specification) and Instrument management.
Sample Management
- Comprehensive Sample Workflow Automation
- In-Built Electronic Worksheet
- OOS & OOT Process Compliance
- Adherence to Part 11 Compliance
- Instant Analytics and Trends
Instrument Management & Connectivity
- Asset Management
- Calibration / Maintenance Schedules & Records
- Instrument Usage Records
- Robust Connectivity with CDS, File-Base and Port-Base Instruments
Caliber Products Abstracts
CaliberLIMS
Comprehensive modular system for Laboratory automation and digitalization from Sample Login to Certificate of Analysis (COA).
A robust Laboratory Information Management System tool for your lab, meticulously designed to help you drive better decisions, perform efficiently and store data securely. Built-in ELN, 20 ‘plug-and-play’ modules, regulatory compliance and many other exclusive features guarantee reduced review time and effective analysis for increased productivity and enhanced quality. CaliberLIMS is assured to be your laboratory’s best companion leading to complete digital transformation.
- Web-based application with 20 Plug-and-Play Modules
- End to End solution for streamlining sample workflow from sample login to COA generation
- Built-in e-Worksheet mapping with instrument and inventories for automatic usage record and stock maintenance
- Comprehensive module for instrument management with calibration schedules, Calibration records, usage, problem/service reporting
Caliber Products Abstracts
- Extensive modules for each type of inventory such as Chemical, Reference standards, working standards, volumetric solutions, Media, culture etc…
- Individual workflow for Stability studies, Reserve Sample, OOS/OOT Analysis, Environmental Monitoring etc…
- Quick and effective decision-making with instant analytics and trends
CaliberQAMS
Meet your Quality Goals by being Fully Compliance
CaliberQAMS offers you a highly configurable, workflow-driven process automation designed as per 21CFR Part 11 and cGMP regulations. CaliberQAMS helps you in Creation, Review, and Approval of change request, deviation recording and hence, automating your entire QA process. This results in easy planning, scheduling and executing self-inspections, vendor audits, and regulatory audits. Through an integrated approach, CaliberQAMS facilitates task management of follow-up actions through CAPA and Training.
Caliber Products Abstracts
- Easy to configure workflows
- Harmonisation of process across organisation
- Actionable analytics for enhance controls and informed decision making
- Seamless integration with SAP, DMS for an integrated quality approach
- Dashboard to view status of deviations, incidents originating from each plant in a multilocation enterprise
- Different types of performance index reports like Issue cycle, action plan etc…
- Configurable escalation matrix
CaliberDMS
Web Based regulatory system for managing Document Life Cycle
CaliberDMS is web-based Document Management System that ensures consistency and compliance with Standard Operating Procedures (SOPs) for managing your documentation lifecycle. This solution enables organizations to create, manage, review, approve and store all type of documents involves in entire process regardless of departments.
- Configurable system for creating documents, change, review, approval with E-sign
- Compliance with regulations such as 21 CFR Part 11, FDA as per CGMP
- Document routing from other systems like QAMS, LIMS etc
- Fact filing and retrieving documents
- Highly secured and authorised workflow
Caliber Products Abstracts
- Auto alert mechanism for document review, approval an change
- Possible to merge various documents from different departments
- Access document over intranet OR internet
- Controlled access to the documents
Nichelon5 Competency Management System
Manages complete life cycle of trainings for entire organization
Training Coordinators and Department Managers face the huge challenge of Managing GMP personnel competency levels and status across the enterprise. Systematic planning, execution and the required testing effectiveness make this an extremely tedious task. Quick tracing of records from numerous archives is an even bigger challenge, as evidenced by the huge number of reported 483 observations(non-compliance), related to training and training records. Nichelon5 CMS is here to help!
- Manages entire life cycle of training viz schedule training, mark attendance, On-line and Offline exam, test results and certification
- Long / Short term evaluation with analysis of need for re-training
- Built in training calendar
- Training records can be retained securely
- System records trainer feedback and training costs
- Built in document repository with version control for training materials and SOPs
Caliber Products Abstracts
- Configuration of dash boards for quick information and drill down capability to view detailed information
- Comprehensive reports designed to retrieve the training records, training plans and relevant information
CaliberBRM
Scalable Electronic Batch Records Management System(eBRMs) that manages your entire manufacturing process with Compliance
Manage your entire life cycle of Batch Records from preparation to product release with CaliberBRM. Here is a scalable Electronic Batch Records Management System(eBRMs) that manages your entire manufacturing process, making the process compliant with FDA regulations and equipping you with the right information about your batch. It meets your fullest automation needs as it easily integrates with generic ERPs, instruments, and hand-held devices/tablets (iOS & Android compatible).
- Tool to convert existing process templates and instructions
- Customised BRT with configurable, re-usable templates and quality inspection protocol
- Label printing Pre-post dispensing confirmation labels with barcodes and Lot sampling
- Rules and validation engine to define batch record workflow
- Seamless integration with SAP, LIMS and QMS
- Built-in eLOG and machine integration
- Easy retrieval of documents / records as and when required
- Access and Security norms as per 21 CFR Part 11