IT Quality Framework
A solid IT Quality framework and governance provides structure and consistency for efficient execution of work. Also, in this heavily regulated environment, is the starting point for being able to successfully navigate audits.
At Hawkins Point, we understand the value and structure that documented processes can bring to a young IT department, as well as provide guidance to an established group climb to the right level on the maturity scale. To accommodate, we offer an assessment of IT Quality Management System (IT QMS), developing and implementing a roadmap to get to the right level of maturity, while balancing costs with compliance.
Computer System Validation (CSV) Methodology
In the industry, the term Computer System Validation (CSV) has wrongly become synonymous to inefficiency, costly and road-block. At Hawkins Point, our philosophy is that when the right balance of process and training, supported by the right tools, leads teams to deliver and maintain systems in the most efficient and effective manner. This helps keep companies be compliant to regulations, as well as deliver the consistently high-quality solutions required when dealing with human lives.
To help achieve this level of quality and efficiency, we provide GxP/CSV assessments, process standardization expertise, awareness trainings, as well as project validation implementation support.
Vendor Audit Management
Being able to partner with good solution providers is key in this fast-paced environment. It allows for the company to focus on the key products being researched and developed to improve human health while leveraging the expertise and experience others have gained through standardized systems to meet business needs. That said, it is important to recognize that partnership does not transfer accountability, and therefore steps need to be taken to ensure continued success and compliance.
Hawkins Point bring many years of experience with the challenges faced by vendors providing traditional client/server systems, to the Software as a Service (SaaS) and Cloud-based solutions.
CSV Execution and Change Control
Equally important to setting up validation framework and methodologies is the ability to execute them effectively. In today’s hybrid environments, a solid understanding of the difference between on-prem implementations vs hosted vs SaaS with a keen understanding of the impact to validation plan execution is an important distinction and experience our team brings. Our team of Computer Systems Validation (CSV) Leads are specialists skilled at authoring validation plans and summaries, understanding of Quality SOP’s to ensure a successful execution of the validation plan, review and approval for all other relevant deliverables (i.e. requirements, design/config, test plans, protocols and executions, summaries and traceability).