Laboratory Management System Services

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Specialized LIMS Implementation, Validation and Optimization Services

One of the critical data sources for clinical development decision making is the clinical trials lab data generated across subject visits per the clinical trial protocol. Therefore, sponsors and CROs have a huge responsibility for implementing, validating and continuously ensuring that the Laboratory Information Management Systems to guarantee accurate results.

Our LIMS Consulting Practice

With our LIMS expertise, Techsol provides professional services that encompasses all critical activities that is part of a LIMS lifecycle.

Lab Research | Techsol

Strategic Consulting

Our team of LIMS Subject Matter Experts can provide strategic guidance with best-practice frameworks to complete:

  • Identifying Use Cases for LIMS Requirements Gathering (URS, FRS, Non-Functional, Regulatory, Reporting, Integrations, etc)
  • Performing System Selection and Fit-Gap Analysis
  • Creating a strategic LIMS technology roadmap (Multi-phase technology adoption)
  • Preparing Trackwise system implementation plan

LIMS Consulting

LIMS System Implementation & Validation

Using the GAMP 5 Risk-based validation methodology, we have developed LIMS implementation accelerators that reduces overall effort for completing setup, validation, and  system rollout. Our key validation activities and deliverables for a LIMS implementation includes:

  • LIMS Installation, Configuration, Integration and Customization
  • System Requirements Specification, Risk Management Report, Validation Master Plan
  • Validation of LIMS to guarantee 100% GxP compliance to 21 CFR Part 11, EU Annex 11, and other regional regulations.
  • IQ/ OQ Test Scripts and Reports, Requirements Traceability Matrix and Validation Summary Report
  • Technical Documentation (User Manuals) and Process Documentation (SOPs and Work Instructions)

GxP Process Management

Post-Implementation Configurations Management & Application Support

We offer SLA-based LIMS application support through our Service Desk across time zones. This includes:

  • Handling user requests (application help, password reset, configuration change, etc.)
  • Performing user access management (Roles, permissions, access grant / revoke, etc.)
  • Resolving incidents by working with Sparta product management group
  • Addressing new LIMS configuration requirements
  • Facilitating IT  change management

LIMS Application Hosting, Data Migration & Application Upgrade

If you are planning to move away from a manual process to LIMS, our team can provide both process and technology consulting services for:

  • Fully-managed LIMS hosting on Techsol Cloud
  • Source Data Migration & Testing
  • Performing Application Upgrades
  • Establishing System Integrations with LIMS
  • Developing new reports and dashboards to provide insights on LIMS processes

Our LIMS Service Delivery Framework includes:

  • Continuous SME Guidance for initial implementation, remediation, and system upgrade
  • Support for initial and ongoing change management
  • Project Management for Global System Deployments
  • Post Implementation Hypercare and End-User Support (SLA-based)
  • Providing expert resources (Clinical Lab Informatics SME, Project Manager, IT Experts, Validation Specialists)
  • Fast and Accurate Data Migration Strategy Consulting
  • Continuous Integration and Continuous Deployment

Let Us Know on How We Can Help You