Partnered Service Solutions for Healthcare IT Companies
Partnered IT Services
Software Compliance & Validation
Partnered IT ServicesSolutions that help Healthcare IT Companies create loyal customers and increase profitability
Why Partner With CSA?
We have years of experience supporting healthcare technology and understand requirement of working in healthcare environments. We provide medical equipment maintenance and repair on most equipment types and modalities. Our field service engineers are very familiar with the healthcare environment and the procedures that are required by many healthcare institutions such as proper check-in, vendor credentialing and HIPPA. They receive all the safety training required to work in hospitals or clinics where there's potential exposure to blood-born pathogens. They're also equipped with the necessary test equipment including electrical leakage testers, patient simulators and imaging phantoms.
We’ve streamlined the complete service delivery process and incorporate all aspect of technical service operations and field service delivery to provide the most complete service outsourcing solution in the industry. Over the past 18 years, we have managed critical service delivery processes on our clients’ behalf with a commitment to operational excellence, innovation and world-class customer service.
Our nationwide service organization can leverage the backing of more resources and more experience to streamline the delivery of quality support services. Our service operations infrastructure and service delivery processes have been continually refined over years, across multiple industries. We understand the emerging service delivery trends and emerging technology that is necessary for the efficient delivery of quality technical services. When we identify efficiencies or process improvements that can lower costs, we act.
Growth that is maintainable and profitable is what most businesses are pursuing. And the opportunities for growth in the medical device and equipment industry are clear. As a service delivery partner, we establish a continuous improvement communication loop with each of our clients to communicate results, hone our deliverables and proactively prepare for future needs. We work with our clients to establish a clear roadmap so we are prepared to scale quickly and effectively.
Every client’s needs are unique. We provide flexible customized solutions based on our client’s needs and business objectives. We can complement your existing service resources or provide a complete service operations outsourcing solution. We provide a flexible managed solution, therefore it can be deployed for a one-time engagement or an ongoing partnership. We have the largest dedicated implementation team in our industry. We manage successful implementations by clearly understanding our customers’ needs, challenges, and requirements prior to designing the processes.
Quality is at the heart of all our operations. Whether it is a recall for a medical device or regular maintenance, our clients rely on us to deliver the best quality talent and services. We’ve invested in and operate on state-of-the-art service management, logistics, training and quality systems. Our quality system incorporates efficient workflow processes to ensure that all CSA associates are equipped to consistently deliver quality.
The key to growing a successful business over the long term is customer loyalty. Without loyal customers a business will eventually wither away and die. Great products can create customers, but it's excellent service that creates loyal customers. We're experts at delivering high quality service solutions that create and maintain customer loyalty. Our Customer Centric Service Delivery Model serves as the foundation of our ability to consistently deliver excellent service at an affordable price.
Some businesses treat service as a necessary evil and the cost of doing business. They view service as a cost center. However, we see service as a profit center that, if done right, can generate revenue and create loyal customers. We've helped many companies use service as a strategic growth engine that ensures long term business growth. We provide expert consultation and guidance to help our clients make this transformation.
It takes a significant investment for a business to create its' own service organization. And along with the investment comes a lot responsibility, hassle and financial risk due fluctuating cost and workload demand. Our fixed pricing model enables our clients to know their service delivery cost down to the penny. Being able to accurately predict service delivery cost results in simplified budgeting, predictable margins and elimination of all the risk.
Clinical Education ServicesA Proven Partner for Providing Healthcare Informatics Applications Training & Support
CSA Clinical Education Solutions add value and staffing flexibility for Healthcare IT (Informatics) companies with our professional nationwide team of Clinical Educators. We have a proven record of accomplishment in recruiting, training, and retaining resources. We offer per-diem and contracted resources so you can control your baseline staffing overhead and customer or patient education costs. We offer flexible solutions that can be customized to meet your contract needs.
Expertise You Can Count
Our Clinical Educators consist of critical care registered nurses, radiologic technologists, sonographers and respiratory therapists that bring instant credibility to your product life-cycle needs or staffing requirements. These clinicians make us proud everyday with their tremendous knowledge, expertise, customer focus, and flexibility. If your needs involve Clinical Educators in other care environments or disciplines, we can meet those requirements too.
Our nationwide team is strategically located across the country. They all have experience providing clinical application support for most healthcare informatics disciplines. We provide end-user and/or super-user education, create and change device configuration, and offer go-live support on medical devices. Our Clinical Educators have a high technical learning curve. All educators are located in metropolitan areas for cost effective and efficient travel. In addition, all of them complete a thorough CSA and vendor orientation; which includes all education modules needed for vendor credentialing.
Information Systems We Support
We are able to assume all of your clinical support needs, augment your full-time staff, or work side-by-side with other subcontractors to ensure you can stay focused on your business and your customers.
Software Compliance & Validation ServicesExpert FDA regulatory services for software compliance
FDA Compliance for Software
Software is as critical to business success as pen and paper – probably even more so. Enterprise systems significantly improve an organizations performance by automating a wide variety of data transactions and business processes. Effectively implementing a large enterprise system, such as a LIMS or ERP, can be a major challenge under the best of circumstances, particularly for life science companies which must comply with FDA and international regulatory requirements for functionality, security, data integrity and electronic signatures through enterprise software validation. In fact, many organizations continue to struggle with software validation despite a sharp increase in FDA 483s and Warning Letters over the last few years.
A common misconception is that enterprise software validation provides no value and only serves to document the obvious for the FDAs benefit. This is far from the truth. Validation proves to the FDA that the system is suitable for its intended use and that any potential impact on product quality is minimized. While additional work is required, it doesn’t have to last for months on end if risk is properly analyzed at the onset. This approach has the added benefit of providing fresh insight into how the system should be deployed and where its weaknesses are.
IT Systems Validation
The evolution of network technology has opened the door to many new applications that were unimaginable even 10 years ago. Today, most software systems are run over powerful networks, WANs and even the internet rather a single, isolated computer. But while the power of networked computing is indisputable, it creates another layer of complexity that must be proven to conform to FDA requirements. The IT system infrastructure is validated to establish requirements and tests for the network hardware, bandwidth, connectivity and operating systems upon which software applications run. This can seem overwhelming given the widespread use of computers and software today, but this doesn’t have to be the case.
CSA can help by asking the right questions about how your system will function and what the risks are. Questions such as: how are the system boundaries defined? What exactly needs to be tested? How do I know what my critical requirements are? Do we include hardware as part of validation? Can certain functions be ignored completely? Our risk management techniques for GMP software validation can identify and analyze critical system requirements relative to regulatory and your business requirements.
Let CSA help streamline enterprise software validation for your next system implementation while reducing the overall cost of compliance.
Our experts can support almost any type of configurable or customized software. Our experience includes:
Software Validation Methodology