Providing Comprehensive Business and Technology Support to Life Science and Healthcare Companies
Focusing on providing servcies for the Life-Sciences including Pharma, Biotech, Medical Device, Diagnostics and Healthcare.
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.
Inspection Readiness, QMS Services, Response Management
Compliance Guidance for Your Development and IT Groups Software Selection, Validation and Infrastructure Management
Life Science focused process design and solution selection. Data Integrity Programs and Assessments, Process and Software Validation
Aligning Stategic Goals with Investments and Actions
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.
Our focus is on providing high-value expertise driven consulting at all levels of an organization. Our consultants have decades of experience in R&D, IT, Manufacturing, Innovation, Program and Project Management, typically in Senior Director, Vice President and C-Level positions.
Our areas of expertise centers around the regulated life-science industries including:
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)
As you move from product development to clinical trials and manufacturing you need to both scale your processes and also adapt to the need for increased controls and process in order to meet regulatory scrutiny. TEC Systems, with our decades of practical experience, can work with your team to find the correct balance and approach to ensure healthy growth and the ability to meet regulatory and customer expectations.
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.
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.
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 .
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.
Whether you need assistance with implementation of Document Control or Change Control, or need to build a QMS from the ground up we have your team. TEC can provide experts in supporting your Quality needs
Using industry best practices we work with you to assess, identify. and address issues with an ultimate goal of transitioning to a proactive approach to inspection readiness.
TEC will work with you to design an inspection readiness program aligned with your goals. Opportunities and risks are identified using a multi-faceted approach of assessments, audits, document reivews and establishing GEMBA like walk-thorugh programs for key areas.
Follow-through is important and our approach includes rigorous follow-through of and reporting progress on identified areas as part of a remdiation plan.
TEC offers training and consulting services to meet Qualty needs throughout your organization.
In today’s information intensive world it is more critical than ever to ensure that you manage your technology investments. Whether its ensureing your IT department meets regulatory and operational expcataions or your software product development meets both market and regulatory expectations TEC Systems can help. We bring decades of experience manging IT and software product development for life-science companies and we understand what is required and how to speak your languge.
TEC Systems brings a thorough understanding scientific principles and the market realities of life-science companies in the development and support of scientific and product software
TEC starts by bringing together your engineers, product managers, Quality and regulatory teams in a structured process where we work to adapt your development practices to comply with regulation.
TEC has extensive experience in adapting agile methods and leveraging both classical and devops centric models in solving compliance challenges. We combine this experise with our knowlege of Medical Device and Digitial Health regulatory ecosystem.
Managing IT groups in regulated life-science companies requires a knowledge of the technology, science and the regulatory environment. TEC Systems offers a range of services to ensure your IT Department is able to support your unique scientific, commercial, and data needs while maintaining compliance with relevant regulations.
We can design and adapt training for your both your product engineering and information technology staff, bringing them up to date with current regulatory expectations and how these expectations translate into the world of technology and software engineering.
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.
We have extensive experience working with leadership teams to align on your strategic vision and to develop, prioritize, execute and monitor operational investments to achive that vision.
Our operational services are founded on deep expertise in life science operations, deep knowlege of applicable regulations, and practical experience running successful organizations. Our team brings decades of experience in running all aspects of the modern life-science company. If you are at that critical stage of scaling your operation, optimizing processes ensuring the success of a critical program our team brings deep experience in all aspects of running a life-science companies from laboratory management, software selection (ERP, LIMS, CDMS, CRM, etc) to XXXXXXX
With TEC Systems processs design and implementation begins with undestanding your business and your commercial, regulatory and scientific environment. TEC consultants, senior leaders from regulated life-science industry, work with you to incorporaate your objectives and drive results. Our extensive experience running commercial organizations combines with your team to ensure success in process design, technology solution selection, and when needed validation. (Process & Software).
We work across the life-science space (Diagnostics, Pharma, Medical Device, etc.) to help improve the operation of laboratories through through rigorous application of process design, system selection and program managment. Our expertise includes laboratories throughout the product life-cycle from R&D to production including FDA and CLIA regulated labs.
Over the past decade we have seen an acceleration in the adoption of digital tools which generate and process electreonic data However the reality is that most companies face a patchwork of manual and paper-based processes integrated with equipment and systems that have been introduced by individual departments to meet local needs. This patchwork of systems and processes is a barrier to ensuring that your data is protected and meets regulatory compliance expectations.
TEC Systems has the necessary knowlege and expertise to understand the technolgy and context of your business processes and help you demonstrate compliance.
Data Integrity Assessments and Audits
Development of Data Integrity Policies and Proceedures
Data Integrity Remediation Programs
Implemnation of Data Governance
Process Validation
Software Validation
Environmental