We deliver IT Quality as a Service, authoring and review of compliance documents offered as a Managed Service Provider (MSP).

Whenever patient safety is involved, IT systems are subject to regulatory compliance and strict adherence to applicable rules and regulations. We understand how to balance risk, support informed decisions, and deliver timely solutions to meet the demands of your business.

.

Download our Top 10 Considerations for High Value Managed Services PDF

Download the Whitepaper

  • This field is for validation purposes and should be left unchanged.

Meeting the Challenge

We have decades of experience helping our clients meet the challenges that can be addressed by way of an outsourced or managed services provider model.  We bring an extensive knowledge base of proven methods that ensure a repeatable and predictable approach to moving a business function to an MSP.  We achieve results that enable our clients to focus their resources on high value initiatives and position us as a true business partner.

Major Challenges We Address

Our Delivery Approach

Results We Achieve

as a SERVICE

Hawkins Point helps companies achieve quality systems compliance by leading Quality inititives.  We plan and execute successful implementations of computerized systems within a GxP environment. 

 

Quality Systems Compliance

We interpret regulatory guidance (GxP) and client policies and procedures into executable and defendable lifecycle documentation. We provide quality assurance oversight for system related issues, and guidance to project teams on the compliance requirements. We follow risk-based methodologies as it relates to CSV and general Quality practices.

Authoring, Review, and Approval of SDLC Documents

We support the development of all life cycle deliverables in compliance with the governing regulations and procedures (i.e., URS, FS, DS, Risk Assessment, TM, etc.). We perform supporting quality related activities associated with computerized systems including periodic reviews, procedures, defects, test scripts (IQs, UATs, System Tests, PQs etc.) Change Management, and test runs.

Leading Quality Efforts

We provide input and guidance on level of procedural rigor, Quality documentation workflow, compliance standards, and adherence with FDA, ISO, GAMP and other applicable regulations and industry guidance. We embrace your culture and integrate as part of your team to ensure practices are consistent and comply with organizational standards. We maintain all required trainings to maintain 100% compliance with procedures, job aids and work instructions.

Implementing the MSP Model

Hawkins Point implements our Managed Services Programs leveraging our four phased approach to assume responsibility for a scope of work.  Each phase builds seamlessly upon knowledge gained in the previous phase, ensuring the various processes, delivery management practices, tools for governance, continuous improvement, and change management are defined and in place before commencement of ongoing, steady state operations.  

We’ve Helped Dozens of Companies Achieve Their MSP Goals

Hawkins Point offers a full range of IT Quality services that will ease the burden on your team, and deliver the highest quality results, with great speed and efficiency.