Quickly staff projects with high-value US and Eastern European experts

Competency

We have extensive experience in assembling and managing teams of experts including Business Analysts, Project Managers, Solution Architects, IT Administrators, Software Developers, IT Support, QA Specialists, and Validation Specialists that can deal with complex laboratory business and IT challenges.

Onshore & Offshore

We utilize a team of US based project professionals that we can supplement with offshore Eastern European resources, to create a symbiotic team that delivers greater value than using either onshore or offshore alone. This allows us to quickly scale up skilled personnel to bring the right amount of resources to any project for today's constrained laboratory budgets.

High Level Contributors

Our teams are highly experienced at dealing with the complexity associated with large scale projects and our software consultants usually become high level contributors and mentors to your staff during projects.

Supplement your in-house effort or fully outsource your project.

We use 21st century technology including cloud, LAMP, and mobile solutions.

Competency

We are Cloud Informatics Company and have extensive expertise in architecting and developing solutions on a LAMP (Linux, Apache, MySQL and PHP/Python) stack and deploying those solutions on Amazon Web Services, Google Cloud Platform, Private Cloud, and Microsoft Cloud. We develop full web based solutions and applications for multiple platforms including:

• iOS
• Android
• Windows Mobile
• HTML5

Web Portal

Our modern, cloud based, web portal, allows clients a direct connection to your laboratory, all through a web interface, without installing any software locally (zero client). Intuitive and easy to use means that our clients rapidly adopt and use this portal. Our web portal can be customized through our professional services group and can interface with EMR's, Laboratory Information Systems (LIS), CRMs and any other HL7 ready system.

Supplement your in-house software validation efforts in regulated environments

Validation Professional Services - a “must have” for assuring compliance and conformance in life sciences and regulated environments processes and workflows

BGASoft offers professional services to provide or supplement your in-house software validation efforts in regulated environments such as life sciences.

BGASoft provides validation experts to manage or partner with your validation and quality teams throughout the full life cycle of the project. With Business Process Mapping and clearly defined risk strategies during project planning, we help to provide clear and compliant plan. Whether your requirements are to make additions or modifications to existing business workflows; instrument interfacing for automated run scheduling and data collection; site specific reporting; or interfacing to LIMS, SDMS, ELN, or other software systems – BGASoft ensures your IT systems are compliant and fit for purpose.  

BGASoft subject matter experts can review and analyze your existing data workflows and help you achieve more efficient and intelligent use of your data. We are able review gaps and analyze existing systems. We can offer a data analytics solutions for better use of the processed existing data. We can help pinpoint and identify where there may be difficulties; or areas to streamline; and recommend solutions to better manage and use the data produced. We’ll help you establish and maintain compliance and data integrity, achieving 21 CFR Part 11 compliance.

Contact us to discuss your “must haves” for compliance and conformance in Life Sciences and regulated environment processes and workflows.

Competency

Our validation project team works very closely with our clients; projects involve clear and effective communication between the client and our professional services teams under the responsibility of the client’s Quality group.

Validation projects typically address:

• Complete validation SDLC of Configured Off The Shelf (COTS) systems
• Gap remediation and retrospective validation
• Modifications to existing business workflows
• Building custom interfacing
• Interfacing lab systems – CDS, LIMS, SDMS, ELN
• Interfacing with other internal and external business systems
• Instrument interfacing and validation for automation
• Bar code and report interfacing and validation
• Issues (Ticket) Management SDLC

SDLC Deliverables

• PMBOK driven Project Plan
• Change Control
• Validation Plan including Risk Assessment
• Test Plan
• Business Process Mapping
• User Requirements Specifications
• System Design Specification
• System Architecture Specification
• Functional Requirements Specifications
• Configuration Specifications
• Data Migration Plan
• Data Migration Test Plan
• Installation Qualification
• Operational Qualification
• User Acceptance Testing
• 21 CFR Part 11 compliance specific testing
• Requirements Traceability Matrix
• System Integration/ Integrity Testing
• Report Development and Validation
• Validation Summary Report
• Process Monitoring
• Training Plan

Reduce total cost of ownership from the start with an experienced partner

Competency

Designing and documenting software architecture is a complex strategic process that is critically important in any project. Long-term success of any implementation depends on getting the architecture correct because it reduces the total cost of ownership over the lifetime of the project by reducing the maintenance and improving overall quality. BGASoft has developed and deployed a large number of successful custom software projects; in doing so we have accumulated a great deal of know-how and best practices.

Transition from requirements to success

Having an experienced software architect is essential to any project. That's why BGASoft works only with highly experienced software architects who have successfully developed and deployed in a timely manner. We have the experienced architects and best practices to bring to any project and make it successful.

Build the solution you need on our open, flexible informatics platform

Competency

LIMSABC is a modern cloud-based framework that can be deployed on your servers or hosted on Amazon or other web service provider. We offer turnkey solutions in our target markets but sometimes more sophisticated and customized solutions are required. BGASoft can quickly and efficiently analyze your most important business and operational needs and develop solutions to exactly meet your laboratory requirements.

Features of the LIMSABC framework

• LAMP stack (Linux, Apache, MySQL and PHP/Python)
• Flexible data model
• Easy integration via HL7, ASTM and web services
• Intuitive and responsive, built on HTML5, CSS, Javascript
• Database level audit trails
• Edit report templates in minutes
• Role based access and security

Get more out of your existing Laboratory Informatics System

Competency

Give your existing Laboratory Information System or Laboratory Information Management System a performance overhaul. Today's business environment is demanding more from a LIS or LIMS than it was designed for. Access decades of domain know-how and laboratory experience within BGASoft. We can quickly put together a project team that will allow you to get more out of your existing system. We have a proven track record of delivering extensive improvements to LIS / LIMS such as STARLIMS and other systems. You can get more from your investment in weeks than you have in years.

We have helped our clients get more

• Defining key business and operation needs
• Workflow analysis and optimization
• System configuration and architecture improvements
• 21CFR Part 11 compliance
• Create and modify Crystal Reports or other Report Engines
• Customization, configuration, and development
• Database performance tuning
• Instrument integration
• Validation and verification
• Software updates
• Training
• and more