Whenever patient safety is involved, IT systems are subject to substantial regulatory compliance and strict adherence to applicable rules and regulations. We understand the best ways to balance risk vs. delivering solutions quickly to meet the demands of your business.

We develop a right-sized approach, leveraging appropriate technology, providing key personnel, and utilizing our extensive knowledge and framework to deliver solutions quickly and in a compliant manner.

IT Quality as a Service

We offer IT Quality services in an outsourced model as a Managed Service Provider (MSP).  We deliver using a proven methodology and successful MSP model for ITQ that will enable you to commit human capital where there is greater value to your organization. We work closely with your quality organization and IT to create a service architecture that will give you greater visibility into operational needs, planning, and execution.

  • We offer a full range of IT Quality services that will ease the burden on your team, and deliver the highest quality results, with greater speed and efficiency.
  • We lower operating costs, provide a flexible staffing model, and deliver high quality of deliverables.

Quality Manual

Every Life Science organization recognizes the importance and value of having formal quality policies and procedures in place.  Our team of ASQ certified quality experts can help you to define your own unique roadmap and to craft your policies and procedures.

  • We understand that every Life Science organization is unique and has different needs and expectations with respect to its quality processes.
  • We help you choose the path that suits your needs, mitigates risks and aligns with industry and regulatory guidelines & best practices.

We offer IT Quality services in an outsourced model as a Managed Service (MSP). We deliver using a proven methodology and successful MSP model for ITQ that will enable you to commit human capital where there is greater value to your organization.

Computer Systems Validation

Life Science organizations commit to CSV at different times and in different ways during their evolution. A CSV framework must be in place to set guidelines, safeguard controls, and mitigate risks. Our team of experts can help you to define, implement, and operate a CSV framework and develop the policies and procedures that will govern validation for your organization.

  • We help assess the current state and lay the foundation for best practices and industry standards.
  • We have decades of experience in all aspects of CSV and offer a broad range of services to meet your specific needs.

Audit and Inspection Readiness

We support companies who are preparing for audits and inspections. We map current business process workflows used to manage the development, collection and curation of research documentation/outputs which supported pre-clinical research and regulatory compliance to applicable predicate rules.

  • We document the operational business requirements, mapping of data sources and consumers, and data integrations, including to third party service providers.
  • We document data integrations with internal systems and partners supporting research studies, clinical trials, and overall data management for all regulatory compliance activities.

Quality Management Systems

We understand how to assess environments and then instill the necessary governance, which includes a Quality Manual and CSV policy, validation deliverables, program governance and project management framework, assets and accelerators to build out the turn key quality systems, and execution work instructions to ensure successful validations and implementations. We develop all documentation and processes, and perform assessments based on current industry standards. 

 

  • We implement frameworks for contract SLAs and provide vendor management services on behalf of our clients, reducing validation and systems administration burden.

  • Our decades of experience in all facets of QMS can help accelerate the timeline for implementing these critical processes and to deliver a robust technology platform that will grow with your organization.