Quality and Compliance services offered in an "as a Service" model, where our focus is always on patient safety, product quality, and data integrity.

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.

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Meeting the Challenge

We have decades of experience helping our clients meet the challenges that can be addressed by way of an “as a Service” model.  And we are skilled at applying this experience to achieve the Quality and Compliance needs of our clients.  We bring an extensive knowledge base of proven methods that ensure a repeatable and predictable approach to moving a business function to this model.  We achieve results that enable our clients to focus their resources on high value initiatives and position us as a true business partner.

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Major Challenges We Address

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Our Delivery Approach

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Results We Achieve

as a SERVICE

Hawkins Point helps companies achieve quality and compliance by leading providing these services in an “as a Service” model. 

 
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IT Quality

We support the development of all computer systems validation life cycle deliverables in compliance with the governing regulations and government regulations and industry best practices (GAMP5, PIC/S, ICH). We perform quality activities associated with Business Process definition, User Requirements, Validation Planning, Specifications, Tesing (IQ, OQ, UAT, Regressions, etc..), Traceability, Reporting, Change Management, and Periodic review.

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Quality Management System (QMS)

We implement turnkey Quality Management Systems (QMS) that includes Quality Manual and CSV policy, validation deliverables, program governance and project management framework. It also ensures qualification of infrastructure laboratory, manufacturing, and enterprise infrastructure. The implementation of the QMS is strengthened by our extensive knowledge base of assets and accelerators.

Implementing the as a Service Model

Hawkins Point implements our as a Service 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.  

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We’ve Helped Dozens of Companies Achieve Their Quality and Compliance Goals

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

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