We offer the widest range of solutions for Process Automation, Quality Management and Regulatory Compliance.
We create products that enhance operations and transform regulated enterprises with efficient, thoroughly compliant and secure automation solutions. Discover today how we can collaborate and support your Quality Assurance, Quality Control, Manufacturing and Future Enterprise Analytics needs.
A robust laboratory information management system tool for your lab, meticulously designed to help you drive better decisions, perform efficiently, and store data securely. CaliberLIMS is designed for regulatory compliance-adhering to the highest level of integrity and ensuring that you meet your company’s regulatory requirements effectively. Built-in ELN, 20 ‘plug-and-play’ modules 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.
CaliberQAMS offers you a highly configurable, workflow-driven process automation designed as per 21CFR Part 11and 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.
Good document management is an essential part of the quality assurance system as per GMP requirements. Having a secure system like CaliberDMS ensures complete compliance with regulatory requirements and additionally guarantees quality and security of your documents. CaliberDMS is a web-based regulatory 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 documents as per GMP and cGMP enforced by FDA.
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).
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.
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 function al framework for your current and future laboratory informatics and addresses all needs of Sample Management, OOS (Out of Specification) and Instrument management.
To ensure the appropriateness and consistency of existing processes, the Annual Product Quality Review is a process required by Pharma GMP (Good Manufacturing Practices ). This process usually takes a few months’ time of senior personnel. CaliberAPQR eliminates this tedious process and heavy investment of time, energy, and resources by recording and tracking crucial data and analyzing it in real-time to make reports readily available to assess product quality anytime!
Complete Lab Aggregator Software System (CLASS)addresses challenges faced by the Quality Control laboratory in managing data generated from Chromatographic, Spectros copy, File based and Port -based instruments. Data is collected and aggregated directly from the instruments and posted into the CLASS database, preventing transcription errors and the risk of non-compliance. The calculations will be done, and combined sample test report (Sample Dossier) will be generated automatically. The software also enables to upload worksheets, reports and any other type of documents related to the respective sample process.