BIOVIA LIMS

Introduction

BIOVIA Laboratory Information Management System (LIMS) is purpose-built to manage 21st-century requirements for informatics supporting lab management processes . BIOVIA’s process- and execution-driven approach to LIMS deployments is fundamentally different from the sample-driven approach of traditional LIMS.

This entirely new approach to LIMS implementations eliminates the complexities, excessive customization and lengthy associated validation requirements inherent with legacy LIMS—offering fast, “out-of-the-box” deployment capabilities, no custom coding, easy integration into existing software platforms and enterprise-wide data management capabilities. The result is streamlined deployments, a substantially lower total cost of ownership and rapid time to value.

By requiring no custom coding, providing automatic workflow validation and enabling flexible and fast deployment, BIOVIA LIMS solves the problems that sample-centric legacy LIMS have for too long failed to address. By focusing on process and execution, rather than samples, BIOVIA LIMS takes a flexible approach tailored to the business requirements of downstream operations and offers substantially lower total cost of ownership and rapid time to value.

No Custom Coding
Each BIOVIA LIMS application comes with Workflow Editors that eliminate tradition al software custom-coding processes, enabling your own internal system administrator to deploy needed applications, workflows and procedures using a simple drag-and-drop process and dialog interface. Start with one of the BIOVIA LIMS applications and simply add the others as needed. By eliminating the need for external consultants and programmers, this approach speeds system deployment while also lowering total cost of system installation and ongoing ownership.

Automatic Workflow Validation
When finished with the workflow editing, a single mouse click generates a complete validation document for the application, workflow or procedure created. Built-in compliance at the “core technology” level turns qualification/validation into a simple, fast document review with no need for external validation consultants, even in regulated environments.

Flexible, Fast Deployment
These key capabilities provide the shortest time to “go-live” in the LIMS industry. With only a few IT resources, plus BIOVIA’s implementation team, LIMS applications can be running and validated in only a few weeks to a few months. The system’s purpose-built workflow and compliance technologies, enabled by BIOVIA’s deep history in R&D, Quality and Manufacturing operations, reduce or eliminate LIMS customization and configuration issues, making the applications truly easy to install and validate without external consultants or programmers.

Applications

The BIOVIA LIMS applications include the following commercial, off-the-shelf applications:

BIOVIA Environmental Monitoring

BIOVIA EM is an enterprise web software application for the centralized and paperless management of sampling plans for microbiological environmental monitoring. The application was developed in collaboration with some of the largest pharmaceutical companies in the world that were seeking an efficient solution to the paperwork-intensive processes traditionally used in aseptic environments.

BIOVIA EM can be used as a stand-alone application or it can be integrated with existing ELN or LES systems to improve documentation efficiency, ensure compliant procedure documentation and reduce manual transcription errors. It is designed to be used on mobile devices like tablets and small laptops.

BIOVIA Inventory

BIOVIA Inventory provides a web-based environment for managing materials, equipment, supplies and reagents within Good Practice (GxP) laboratories and their operations. BIOVIA Inventory enables organizations to adopt and deploy a centralized electronic inventory management system for all GxP operations with a low cost of ownership and lower infrastructure requirements.

The application can be deployed as a stand-alone, out-of-the-box inventory management capability for use with existing electronic lab notebook (ELN) or lab execution systems (LES).

BIOVIA Inventory provides full audit trails and comprehensive, dynamic and static management reports, enabling organizations to meet all technical requirements for 21 CFR Part 11 compliance.

BIOVIA Metrology

BIOVIA Metrology automates all traditional paper, manual and semi-automated tasks associated with the performance of routine calibration and maintenance workflows for simple and complex instruments requiring routine checks such as:

  • Pipettes
  • High-Performance Liquid Chromatography systems (HPLCs)
  • Balances
  • pH meters
  • Titrators
  • Spectrometers
  • Dissolution testers
  • Hardness testers
  • Air testing devices
  • Particle size analyzers

BIOVIA’s Metrology web-based application provides compliant performance verification and routine calibration of laboratory instruments, equipment and devices supporting inventory management, scheduling, protocol/test method execution, data capture and reporting in lab-to-commercialization operations.

BIOVIA Metrology can be used as a stand-alone application or it can be integrated with existing ELN or lab execution systems to improve documentation efficiency, ensure compliant procedure documentation and reduce manual transcription errors. It provides an out-of-the-box environment that can be readily configured to meet specific needs without the extensive and expensive modifications traditionally seen with Laboratory Information Management System (LIMS) modules.

BIOVIA Samples

The BIOVIA Samples application supports a variety of ways to manage the following laboratory workflows in a secure Web-based environment:

  • Inspection lot management
  • Specification management
  • Sample chain of custody management
  • Test execution and result entry
  • Result review and reporting

As samples are collected and submitted, they become visible to the system. Samples are assigned testing workflows and lab location/destination parameters, and the optional BIOVIA Workbook ELN or LES core application features for assigning/managing analytical procedures can then become active.

BIOVIA Samples can be used as a stand-alone application or it can be integrated with existing ELN or LES systems to improve documentation efficiency, ensure compliant procedure documentation and reduce manual transcription errors.

BIOVIA Stability

The web-based BIOVIA Stability application provides an intuitive, drag-and-drop workflow editor enabling study owners to add user-defined properties, schedules and process steps to stability workflows in a simple layout. These properties, shown as icons, link to lot materials, specifications, time-point definitions and the general workflow of the study.

Permissions and workflow actions can be set up to match the business rules of the organization, e.g., who may activate a study (such as study owner, lab manager or lab staff member), whether unscheduled pulls are allowed, how and if a study may be extended and if tests can be added or removed. All changes and edits are fully audited from the initial definition and saved through the approval, activation, use and final closure/archiving of the study.

BIOVIA Stability can be used as a stand-alone application or it can be integrated with existing ELN or LES systems to improve documentation efficiency, ensure compliant procedure documentation and reduce manual transcription errors.

More information about BIOVIA LIMS here!