TEC Systems LLC
Providing Comprehensive Business and Technology Support to Life Science and Healthcare Companies
Remote Workforce Management
TEC Systems Uses a robust combination of process, tools and supervision combined with proactive reports to ensure engagement, quality and delivery of the services we provide.
Ask us for more details on how our approach works for you during these difficult times.
Our Expertise
Information Technology
Software Selection, Validation and Infrastructure Management
Software Development
21 CFR Part 11 and Annex 11 Compliant Custom Software and Compliance Guidance for Your Development Process
Human Resources
Recruiting, Compliance and HR Generalist Support
Quality Systems Management
Inspection Readiness and QMS Services
Focus on your Business – Let Us Support You
Business and Support Technology Services
TEC Systems specializes in providing business and technology support services to Life Science and Healthcare organizations. We understand the unique needs of science and engineering driven businesses which operate in highly regulated environments.
We have extensive experience right-sizing services for businesses which operate under a variety of regulatory frameworks including HIPAA, CLIA, FDA 21 CFR Part 11, EU Annex 11, ISO 13485, IEC 62304, and related guidances such as Software as a Medical Device, and EDC Systems.
Do you need C-Level Leadership but can't justify the cost of a full-time employee?
TEC Systems provides a wide range of engagement models including on-call, fractional C-Level staffing, strategic consulting and interim leadership engagements. For a fraction of the cost of full-time executive you gain access to our executive consultants who provide C-Level expertise to assist in strategic planning and meeting the operational needs of your organization .
Are you overspending for IT Support which doesn't meet your needs as a Life Science or Healthcare business?
We all know that technology is critical to ensuring smooth business operations, but all too often technology vendors and managed service providers don’t understand the unique needs and regulatory requirements. TEC Systems are experts in implementing and managing technology while maintaining compliance with the regulatory framework which applies to your organization. Our team members bring expertise in HIPAA, CLIA, FDA 21 CFR Part 11, EU Annex 11, and ISO 13485.
Is your software development FDA and CLIA compliant?
TEC Systems has extensive experience working with software engineering teams to adapt their existing development process to regulatory requirements. We specialize in translating regulatory requirements in to practical frameworks which fit your team’s culture and agile practices. (ex. 21 CFR Part 11, ISO 13485, IEC 62304, EU Annex 11, and Guidances on Software as Medical Device, and EDC Systems)
Is your Quality Management System Ready?
Implementation of a formal QMS is critical in growing organizations. Our Quality experts can provide assessments of your organization’s QMS, which not only identify technical gaps, but will also help you chart a course forward towards strengthening your QMS and building Quality and compliance into your culture.
Are you meeting Federal, State and local workforce requirements?
The compliance landscape of HR has changed dramatically over the past several years. Companies are recognizing that HR plays a critical role in protecting the Company from legal risks and exposures and maximizing human capital. We evaluate your current processes and provide guidance to improve your compliance.
Are you needing to select, validate and support software for your buisniess?
TEC Systems brings a comprehensive approach to the selection, implementation and validation of software supporting your business. This approach can be right-sized based on your needs and whether you are identifying a solution or have a product selected. Our approach begins with working with your teams to identify the features which are important to your business. From there we work with you to develop and execute a plan that helps you select the best tool for your needs, ensuring that you don’t get trapped by technology issues later in the project. We then work with you to implement and release the software tool, ensuring that all regulatory requirements which apply to your business are met and documented.
Information Technology
Whether you need managed services, IT consulting services, or one time project support, TEC Systems can handle any level of request for your IT environment.
Software Implementation and Validation
We have deep expertise in managing software selection, deployment and support for scientific and commercial software. This includes guiding the you through the process of matching tools to business need, technical configuration, business process design and deployment of a validated system.
Helpdesk and Infrastructure Management
Your workforce depends on technology, keeping it working without breaking the bank is critical. TEC can provide remote and onsite technology support services for laptops, servers and networks. We ensure the installations of all equipment are verified and include Installation and Operational Qualification (IQ/OQ) documentation.
Data Integrity and Governance
Data is at the center of your business and it’s quality, security and accessibility are paramount. We can help you with ensuring that the data you use to make decisions and to support regulatory submissions is available, secure and accurate.
Software Development
Our expertise in software engineering and management combined with extensive domain expertise in the life sciences and helathcare can help you build high-quality software solutions and products.
FDA and CLIA Compliant Development
TEC brings together your engineers, product managers, quality and regulatory teams in a structured process where work to adapt your development practices to comply with regulations. TEC has extensive experience in adapting agile methods and leveraging both classical and devops centric models in solving the compliance challenge.
Custom Software and Technology Staffing
If you have a custom software development project TEC can supplement your teams with highly skilled talent or can provide an entire team. Whatever your needs, TEC has both the technical staff and an understanding of scientific and healthcare applications to support your organization’s needs,
Partial CTO and Interim Leadership
Your business runs on technology and making decisions where to put your technology dollars requires more than just an understanding of the technology. Our executive consultants are expert at linking business strategy, scientific needs and regulatory requirements with technology to improve investment decisions and operational efficiency.
Human Resources
We are human capital experts and strategic integrators of talent, structures, processes, and technology. As an innovator in our industry, we provide effective solutions for our clients and create a positive impact on healthcare and life science organizations. Whether you need assistance in compliance with regulations, HR Generalist support or solutions for difficult HR situations, we offer a range of approaches and services.
Compliance
We review, develop and implement organizational programs and practices to ensure compliance with federal and state regulations governing the workplace. TEC provides compliance solutions to meets the needs of your organization regardless of the longevity in business or complexity of structure.
HR on Call and Interim Leadership
Sourcing, selection, onboarding, performance management, training and employee relations processes are critical element of the company’s ability to achieve/maintain success in its industry. Our team of HR experts can be utilized on an as needed basis for organizations’ most valued asset, human resources.
Staffing
TEC has developed a strategic resourcing model to properly identify, procure, and assure superior resources for any short or long term engagement.
Quality Systems
FDA Compliant QMS Implementations
Whether you need assistance with implementation of a Document Control system or need to build a QMS from the ground up we have team. Experts in FDA compliant QMS implementation including CAPA, Documentation Control, Change Control, etc.
Inspection Readiness Programs and Audits
Using industry best practices we work with you to identify, assess and address issues with an ultimate goal of transitioning to a proactive approach to inspection readiness.
Computer System Validation
More than ever validating computer systems and software requires unique expertise and skills. We specialize in modern approaches to the validation of software. Our expertise includes validation of internal supporting systems to externally facing systems and Medical Devices.