At Orbis Labsystems, we have more than 20 years experience in the planning and implementation of LIMS. We are also experienced in addressing legacy LIMS issues. We can provide the following Business Analysis and Project Management related services for all of your LIMS project needs:

  • Business Requirements Analysis
     

  • Strategic Planning
     

  • Risk Assessment and Management
     

  • Project Organization and Resources
     

  • Project Models
     

  • Quality Assurance
     

  • Regulatory Compliance

Business Analysis & Project Management

LIMS Projects

  • New LIMS Implementations
     

  • Global LIMS Planning, Implementation and Deployment
     

  • Upgrades
     

  • Streamlining and Optimizing Systems
     

  • Integrations to 
     

    • ERP
       

    • MES
       

    • Chromatography
       

    • Instruments
       

  • System Health and Compliance Checks​​

Business Analysis &
Project Planning

  • Business Analysis
     

  • Setting Objectives and Targets for the Solution
     

  • Defining the Future State (Solution) in terms of Functionality and Data
     

  • Defining Business Interfaces
     

  • Focus on Customization Elimination
     

  • Structuring the Project to meet Critical Timelines
     

  • Risk Management
     

  • Engagement with Stakeholders and Subject Matter Experts to ensure Solution Adoption

Risk Assessment

  • GAMP 5 Risk Assessment
     

    • Functional

    • Data
       

  • Testing Strategies

  • Data Review Processes
     

  • Project Risk Assessment
     

    • Weighting

    • Mitigation

Project Organization

  • Effective Engagement between Vendor and Business
     

    • Roles & Responsibilities
       

    • Escalation Paths
       

  • Reporting
     

  • Resource Contingency

Project Management

  • Waterfall, Agile
     

  • Project Tasking & Tracking
     

  • Risk & Contingency
     

  • Team Building & Communications
     

  • Steering & Stakeholders

Quality Assurance

  • ISO 9001:2015 Standard
     

  • GAMP 5
     

  • Data Integrity
     

  • Systems Acceptance Testing
     

  • IQ/OQ/PQ

Regulatory Compliance

  • Data Governance & Integrity
     

  • GAMP 5
     

  • ISO 17025