Session Overview –  Unlock business value through digital transformation. To transcend traditional boundaries, the Lab of the Future requires advanced digital tools and contextualized scientific data that can drive business growth. Learn how to make your vision become reality.

In this webinar, we will discuss:

• How to drive growth with integrated, AI-enriched laboratory informatics solutions
• Why you should embrace a data-driven mindset and culture shift
• What the impact will be on your workforce
• Who a scientific data advisor is, and how they can assist you
• When you should start your transformation to a Lab of the Future

The post On Demand Webinar -Inside the Lab of the Future with LabVantage appeared first on Astrix.

More about the LabVantage Client Portal

Client web portals are increasingly popular in B2B environments because of their ability to streamline collaboration and increase customer engagement without compromising security.

While this technology has applications across many industries, it promises significant efficiency benefits to labs that regularly need to securely exchange data with external clients and third-party partners.

Earlier this year, we talked about the general benefits of using a LIMS portal to enable faster, more accurate interaction with your clients — capabilities that will be available to you in the new LabVantage 8.7 Portal.

In this post, we’ll examine four types of real-world request use cases, and discuss how a secure client portal simplifies them all.

The post On Demand Webinar – Simplify Secure Data Management with the LabVantage Customer Portal appeared first on Astrix.

In the current climate of healthcare, overburdened by the demands of the Covid-19 pandemic, labor shortages, and healthcare systems merging to become mega healthcare systems with disparate systems creating communication and integration issues, a modern LIS system with advanced analytics powered by AI and ML technology can make all the difference in the world.

Developed specifically for laboratories in healthcare settings, LabVantage Medical Suite is a Laboratory Information System (LIS) that integrates all medical laboratory disciplines under one umbrella, addressing the distinct needs and workflows across the medical community providing one solution for diagnostics, microbiology, pathology, blood bank, genetics/molecular, and veterinary labs.

5 Key Benefits of a Unified LIS for All Medical Lab Disciplines

 1. One Platform| All Medical Lab Disciplines

Chemistry, hematology, microbiology, pathology, genomics, and more – in one platform. All disciplines share common features, databases, and interfaces enhancing information sharing and cross-discipline analytics. Due to its modular design, LabVantage Medical Suite can scale to meet your needs by discipline.

2. Best-in-Class Workflows

With the built-in workflow rules engine, the LabVantage Medical Suite LIS can adapt to variations of laboratory workflows and incorporate your desired level of process automation. It provides the flexibility needed to meet the unique demands in your laboratory. The user/role-specific work lists and patient-centered views make the platform easy to use and learn, speeding user adoption.

3. Control Center for Your Lab

LabVantage Medical Suite controls the communication of all instruments and systems, bringing intelligence to the workflow and fully managing and supervising the entire laboratory process. This helps to assure that quality results are delivered in a timely manner to support care decisions and positive patient outcomes.

4. Seamless Integration

LabVantage Medical Suite LIS seamlessly integrates with any laboratory equipment, system, or outside organization in a convenient and validated manner. Integrations are implemented on open standards and interfaces, through HL7 or XML, or any proprietary protocol.

5. Compliance

LabVantage’s Medical Suite integrates fully with EMR, EHR, and pathology systems, and meets HL7 standards established for patient care. Instrument maintenance and analyst certification are fully supported to satisfy industry regulations. Importantly, consent management for tissue procurement meets HIPAA requirements, and tissue acquisition and distribution complies with IRB-approved protocols.

Why it Matters to You

A modern LIS Laboratory Information System (LIS) that seamlessly integrates all medical laboratory disciplines in a unified platform will dramatically improve the quality of patient care. LabVantage Medical Suite LIS digitally transforms the medical laboratory in the following ways:

• Provides one solution for diagnostics, microbiology, pathology, blood bank, genetics/molecular, and veterinary labs.
• Streamlines laboratory operations by automating routine tasks and processes, reducing errors and overall costs.
• Advanced workflow management capabilities increases efficiency, improves your lab work, and therefore the safety and quality of patient care.

About Astrix

For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations. To learn the latest about how Astrix is transforming the way science-based business succeed today, visit www.astrixinc.com.

The post 5 Key Benefits of a Unified LIS for All Medical Lab Disciplines appeared first on Astrix.

A leading diagnostics laboratory that specializes in DNA based testing was in the process of implementing a LabVantage LIMS. Recognizing the complexity of LIMS implementations, the group was interested in engaging a team of consultants to assist with developing a project strategy, establishing a project plan and providing LabVantage LIMS specific guidance to the project team. Due to Astrix’s extensive expertise with strategic planning and LabVantage LIMS implementations, the client selected Astrix to assist with this project.

To successfully execute on a complex LIMS deployment, it is necessary to have proper planning and experienced resources throughout the project team. Projects with improper planning and strategy will fail regardless of the technical aptitude of the project team.

The company was entering a high growth phase and had an immediate need to replace legacy in-house built solutions with a modern COTS solution. The client was looking to streamline their current LabVantage platform to optimize and automate their current workflows including integration to a real-time PCR system in support of their business.

The project goals identified to address these challenges were as follows:

• Develop an architecture that provides the ‘best of breed’ technologies to support the business goals
• Streamline and optimize the existing LabVantage configuration
• Work with the team to develop and refine the proposed integration architecture and data model for the future state solution
• Integration of a real-time PCR system within the overall sample management and testing workflow
• Implementation of the future state LabVantage solution

Project Approach

To successfully execute on a complex LIMS deployment, it is necessary to have proper planning and experienced resources throughout the project team. Projects with improper planning and strategy will fail regardless of the technical aptitude of the project team.

Not only are experienced technical resources required but it is imperative to have a technical lead with a multi-level skill set and prior experience with projects of this magnitude. A technical lead has insight into all aspects of a project including LabVantage LIMS architecture, planning, system design, coding style, change management, roll out strategy, validation and hyper-care.

Business analysts work in conjunction with the team to align business processes, business goals, and technology to ensure that the laboratory informatics project maximizes the overall business value for an organization.

To address the business challenges of the DNA laboratory, Astrix proposed a team of comprised of a business analyst, a technical lead, and informatics engineer to perform a detailed analysis of the workflows that included:

• Documenting a full set of user requirements of the end-to-end business process
• Recommendations for a future state integration architecture that included ERP, specialized DNA analysis and reporting capabilities, and LabVantage as the LIMS solution
• A thorough analysis of the issues related to the DNA testing workflows identified by the users
• Development of a mutually agreed upon remediation plan to streamline the implementation and address issues
• Implementation of the remediation plan to provide a working solution able to be completed within a 6 week time period

Services Provided

For the LabVantage LIMS implementation, Astrix recommended the addition of a business analyst and technical lead with deep technical knowledge of the LabVantage platform. The analyst and lead worked in collaboration with the client and LabVantage teams to perform a detailed business process analysis and construct an implementation plan that included the development of a requirements backlog and project plan for the LIMS implementation.

The project strategy and deliverables for each stage of the process are outlined below:

Provided a detailed assessment of end-to-end business process analysis

• Evaluated both scientific laboratory and business processes
• Outlined areas of process harmonization and standardization
• Identified fit-for-purpose applications
• Determined data analysis and reporting requirements
• Developed requirements backlog

Developed informatics landscape, go-forward architecture and roadmap

• Data architecture, flow and master data management strategy
• Instrument and system integration strategy
• Data migration strategy

Evaluated technical implementation approach and strategy

• Assessed against best practices and scalability for the DNA testing laboratory
• Recommend go-forward technical approach

Defined Release Management Strategy

• Detailed release process
• Assisted with technical environment management

Developed the Implementation Plan and Strategy

• Provided work breakdown structure and estimations
• Identified technical project risks and possible mitigation actions
• Finalized scope for initial implementation
• Defined strategy for scope prioritization
• Created the project resource plan
• Assisted with development of communication plan and governance structure
• Developed Testing and Validation Strategy
• Assisted in development of Change Management Plan and Strategy
• Data migration and data cutover plans
• Go-live planning and training

Estimated the costs and timeline for each stage of the project

• Service hours and cost per resource
• Hours and cost per project stage

The Technical Lead worked with both the client and LabVantage teams to ensure that the project was delivered on time, within budget and achieved the desired business outcomes. Responsibilities of the technical lead throughout the project included:

Provided overall guidance to the functional team

• Evaluation of the current project schedule and implementation strategy
• Facilitated technical problem solving and design related decisions
• Developed test strategies and reviewed the quality of all project deliverables
• Enabled the proper implementation of each major task

Promoted and assured adherence to solid project management principles

• Assisted with work breakdown structure and estimations
• Identified technical project risks and possible mitigation actions
• Followed a defined escalation process

Partnered with the client’s Subject Matter Experts (SME) and technical team

• Assisted with scope/change management
• Facilitated functional requirements support to the development team
• Assisted in defect resolution and prioritization process
• Served as a knowledgeable, trusted adviser to the client

Results Delivered

The project required careful strategic planning for the development and completion of the remediation plan to meet the client’s accelerated timeline due to immediate and increasing business needs. An in-depth business process analysis was conducted to develop an architecture that would provide the ‘best of breed’ technologies to support their business goals. To underpin this effort, Astrix recommended against trying to build a large, monolithic solution that incorporated too much customization within the COTS LabVantage solution.

The Astrix team delivered the project on time, within budget and was able to effectively address all of the client’s needs with regards to the scope of the project. The client was very pleased with the results and was able to achieve the desired optimized workflow.

The results delivered to the customer included:

• A thorough analysis and detailed assessment of the issues relating to the DNA testing workflow
• The creation of an optimized workflow that included a future state integration architecture
• The development of a LabVantage LIMS implementation plan and strategy
• Integration of a real-time PCR system within the overall sample management and testing workflow
• Implementation of the remediation plan, completed within the required 6 week time period

The post Case Study: LabVantage LIMS Implementation for a DNA Testing Laboratory appeared first on Astrix.

A contract research organization (CRO) providing full-service clinical development services to biopharmaceutical and medical device sponsors was interested in implementing one centralized system to manage their biorepository. They choose to install the LabVantage pre-packaged LIMS designed for biobanking (LabVantage Biobanking), as this system is pre-configured to address all aspects of biorepository management.

The customer worked with LabVantage Professional Services to implement LabVantage Biobanking into their laboratories with no customization of the system. Once LabVantage Biobanking was installed, it needed to be validated. As a premier LabVantage consulting partner, Astrix Technology Group specializes in validation services for LabVantage LIMS. The customer therefore decided to partner with Astrix to fulfill its LabVantage Biobanking validation requirements.

Services Provided

Astrix provided two primary resources to the customer to accomplish the necessary validation activities for LabVantage Biobanking:

• Validation Manager – This resource had overall responsibility for all validation services performed and worked to keep validation activities within budget and in alignment with the overall LabVantage Biobanking implementation project plan. The Validation Manager interfaced with both the LabVantage Project Manager and customer resources.
• Validation Analyst – This resource was responsible for the planning, construction and execution of all validation-related Services.

The work the Astrix Team did on this project included:

Validation Plan. The Astrix team created a Validation Plan document that defined the objectives of the validation, the approach for maintaining validation status over the full software development lifecycle (SDLC), and satisfied all regulatory policies and industry best practices (e.g., GAMP 5). The Validation Plan detailed the following:

• Project Scope – outlined the parts of the system that needed validation (those parts of the system that would be utilized by the customer), along with deliverables/documentation for the project.
• Testing Approach – Defined the types of data that would be used for testing, along with the kind of scenarios that would be tested.
• Testing Team and Responsibilities – Listed the members of the validation team, along with their roles and responsibilities in the validation process.
• Acceptance Criteria – Defined the requirements that need to be satisfied before the system is considered suitable for use in regulated activities.

Requirement Gathering. The Astrix Team gathered the necessary information regarding the customer’s intended use of the system that would be used to guide a risk-based approach to validation testing. The following documents were finalized in this phase:

• User Requirements Specification (URS). The Astrix Team worked with the customer to author the URS, which clearly defined what the system should do, along with any operational (regulatory) constraints.
• Functional Requirements Specification (FRS). The Astrix Team worked with the customer to review/revise the FRS, which defined how the system will look and function for the user to be able to achieve the user requirements.
• Design Specification (DS). The Astrix Team reviewed the LabVantage Biobanking DS that were created by the implementation team.

Risk Management. The Astrix Team conducted an analysis of failure scenarios to determine scope of validation efforts. A risk management plan (RMP) was created to document the findings and recommendations which came out of the analysis.

System Qualification and Interim Reports. All installation qualification protocol (IQ) activities associated with infrastructure of the hardware, software, and instrument interfaces were completed by the customer with the assistance of other third-party vendors. The Astrix Team reviewed IQ documentation, and conducted the following qualification activities:

• Operational Qualification Protocol (OQ) with Test Scripts – Wrote test scripts at subject matter expert (SME) level and conducted the testing.
• Performance Qualification Protocol (PQ) with Test Scripts – Wrote test scripts at SME level and conducted the testing.
• Traceability Matrix – Documented the OQ and PQ results in a Traceability Matrix

Closure & Deviation Management. The Astrix Team worked to document the results of the project by authoring the following documents:

• Validation Summary Report (VSR) – A review of all activities and documents against the Validation Plan.
• System Release Document – Documentation that validation activities are complete and that the system is available for intended use.

Results Delivered

The contract research organization (CRO) engaged with the professional services group at LabVantage to install and configure the pre-packed LIMS for biobanking  Astrix Technology group then created a Validation Plan document that defined the objectives of the validation, the approach for maintaining validation status over the full software development lifecycle (SDLC), and satisfied all regulatory policies and industry best practices.  The validation plan detailed the project scope, testing approach, testing team responsibilities, and acceptance criteria. Additionally, Astrix provided the Validation Manager and the Validation Analyst resources to perform the necessary validation activities.

The Astrix Team then gathered the detailed information regarding the customer’s intended use of the system that was used to guide a risk-based approach to the validation testing. The documentation provided during this phase of the project included the User Requirements Specification (URS), Functional Requirements Specification (FRS) and Design Specification (DS).

During the final phase of the project, the Astrix Team conducted an analysis of failure scenarios to determine scope of validation efforts. A risk management plan (RMP) was created to document the findings and recommendations which came out of the analysis. The system qualification was managed in two stages.  The IQ was completed by the customer with the assistance of other third-party vendors. The Astrix Team reviewed the IQ documentation, and conducted the OQ and PQ, with all and results documented in a traceability matrix.  At the completion of the validation, the Astrix Team provided a Validation Summary Report (VSR) and the System Release Document indicating that all validation activities were completed, and that the system was available for intended use.

The LabVantage validation performed in this project by the Astrix Team met the customer’s needs which resulted in significant improvements to operational efficiency, regulatory compliance and data integrity for their centralized LabVantage LIMS and biobanking system. The customer was extremely satisfied with the results of this project having accomplished all of the intended business goals.

The post Case Study: LabVantage LIMS Biobanking Validation for a Contract Research Organization appeared first on Astrix.