HarborView has implemented GxP systems at multiple top-tier Bio-Pharma companies. We have well-developed data models consisting of fact and dimension tables, predefined measures for key supply chain and quality metrics, and an elegant visualization layer.
We provide GAMP 5 compliant requirements and specifications, documented factory acceptance testing , and if requested, IOQ templates. We also provide a full set of as-built specifications to facilitate change management.
HarborView founder Richard Love has over 20 years of industry experience. He has held technical, quality and executive management roles including Global Head of Quality for Dermatology Operations at GlaxoSmithKline.
During his time in industry he has created and deployed multiple GxP information management and reporting systems. His unique background in business, quality and IT give him a powerful combination of skills relevant to your GxP analytics needs.
In short, HarborView has the skills and tools to rapidly develop, test and deploy systems that will transform your business!
Data is the backbone of our industry and how it is used often makes the difference between success and failure.
Let us turn your data into actionable information.
“Richard’s unique combination of leadership, global executive Tech Ops/Quality experience and practical IT skills enable HarborView to deliver truly impressive GxP analytical solutions.
HarborView fulfills its commitment to turn data into actionable information and can help bridge the gap with corporate IT to add real value to the business.”
“HarborView’s ability to quickly design systems to precisely meet our business needs helped make information management a core competency of our business.
Especially valuable to us are the abilities to monitor information in real-time and run highly customized reports.”
"The information management systems Richard and his team implemented not only formed the basis of a very effective virtual supply chain but also greatly facilitated the due diligence and ultimate acquisition of Connetics by Stiefel, a $3billion specialty pharmaceutical company.
Ready access to operational/quality information and the ability to drill down to details proved invaluable to our tech transfer process. "
"I was very impressed – frankly amazed – with the ease and flexibility of incorporating already designed spreadsheets into a comprehensive, integrated dataset.
The use of one comprehensive data management system enabled us to harmonize our approach to similar processes (deviations, complaints, audits, and quality planning) and increase the effectiveness of our quality system.
The integrated system helped our efficiency in monitoring, updating, analyzing, and reporting progress in our work, as we were able to quickly select the best factor(s) around which to pivot our data, and present the resulting report in a consistent format.
The reputation our Quality group had for responsiveness was due in large part to the flexibility of being able to simply “click and go” to prepare and present a report to Senior Management."
“I have used Quality System software applications developed by Rich Love for several years in my role as Quality Engineer, and have seen first-hand the value these GxP systems bring to a Quality department.
I completely relied upon their ease-of-use, functionality, and connectivity to satisfy my duties related to Complaint handling, CAPA management, and document control. I especially appreciated the ability of the GxP systems to share data across several functional areas. This connectivity decreased duplicate data entry, drove increased data integrity, and provided powerful reporting capabilities.
Rich’s ability to understand process needs and user requirements, and then develop a GxP application that meets them, is truly impressive. I would not hesitate to recommend his work to anyone looking for a customized electronic GxP system solution.”
"HarborView understands quality. They are not only experts in data management, analysis and presentation, they bring real world experience in pharmaceutical and medical device manufacturing to their work.
They are responsive, fun to work with, and they are tireless problem solvers who get the big picture but also know the guts of the systems I am working with. I heartily recommend them."
Where does your business need more support? We offer a broad range of services and packages that be customized to your needs. Send us a message today, and we can start you on a path to success.