US-based company Neoprobe Corporation has expertise in the development of diagnostic gamma products – creating gamma detection devices, diagnostic radiopharmaceutical agents, and accessories for surgical procedures such as Intraoperative Lymphatic Mapping (ILM).
ProcessPower Solutions Inc is part of Gael Ltd’s Global Partner Program, introducing clients in the North American marketplace to Q-Pulse, the compliance management solution developed by Gael.
Based in Dublin, Ohio, Neoprobe is concurrently developing both gamma detection systems and radio labelled tracers for cancer surgery. Neoprobe’s primary focus is to improve the diagnostic tools for cancer surgery by using their market-leading gamma detection devices in combination with the new diagnostic
radiopharmaceuticals they are developing.
Neoprobe realised they needed to replace their previous paper-based Quality Management System. By working with ProcessPower Solutions Inc – and following a competitive tender process – Neoprobe chose Q-Pulse as the solution which best met their needs.
The Challenge
Neoprobe had experienced frequent document process inefficiency and accuracy issues with their paper-based Quality Management System, which was neither centralized nor controlled.
Rodger A. Brown, Vice-President, Neoprobe Corporation, said: “Our previous system was a manual process requiring that we work with physical paper documents and files while using an in-house database to catalogue and track our documentation and records, and did not address the other eight elements of an integrated Quality Management System (QMS). Our QMS processes were not as efficient as desired and we recognised the benefits that an electronic QMS would bring to the company. Also, to comply with regulatory requirements we required a centralized document management system with electronic signatures and records capability, and a built in audit trail at a competitive cost. Q-Pulse fitted the bill perfectly.”
The Solution
Neoprobe’s implementation of Q-Pulse helped improve their overall QMS by streamlining and integrating their previous processes. Q-Pulse replaced their old system, bringing with it a series of benefits such as the centralization of their documentation and the introduction of an electronic and cost-effective Quality Management System with complete visibility and traceability of their documents, records and data.
Another major benefit that Q-Pulse provided was that it enabled their internal QMS processes to adhere to multiple regulations and industry standards for healthcare products such as the European, U.S.A. FDA, Canadian and Japanese regulations, and the international standard ISO13485.
Rodger added: “During our initial review of Q-Pulse, we quickly identified it as the solution that exceeded our initial expectations. It was the ideal solution. Q-Pulse would assist Neoprobe in maintaining its ISO13485 accreditation with the full complement of QMS elements. The addition of 21 CFR Part 11 compliance capabilities also enhanced the program for compliance with the electronic records and signatures requirement.
“Q-Pulse offered more for significantly less than competitive products, and for a small business such as ours, that was essential.”
The Result
By turning to Q-Pulse, Neoprobe was able to shrug off their previous laborious, inaccurate and time-consuming Quality Management System, making it easier for them to achieve compliance with the relevant industry standards and regulations.
Rodger added: “Our QMS is reassessed each year by our registrar, British Standards Institute (BSi). Before applying Q-Pulse, we had encountered nonconformances related to the maintenance of documents and records. With Q-Pulse, we have been able to completely eliminate this non-conformance. We have not encountered a non-conformance in the QMS reassessment process over the last three years.”
Rodger continued: “New and current users are pleased with the capabilities of Q-Pulse as it’s so easy to use and once users utilized the Document Module, our efficiency dramatically improved.
“Q-Pulse addresses difficulties in the original document management system such as delayed, lost or misplaced documents and records, with the application of a central electronic process. Efficiency has improved in the areas of document maintenance, records retrieval and data analysis. The document review and approval process that used to take days or weeks can now be completed in minutes or hours once the user logs on.
“Our quality and regulatory departments utilize the Q-Pulse modules to keep track of compliance with the key elements of the fully integrated QMS requirements as they are defined in industry standards and regulations for the life sciences.
We’ve seen time effective improvements such as being able to access and export real-time data related to product vigilance and supplier non-conformances in quarterly reports to upper management.
“We have utilized the Q-Pulse application for four years and are pleased with its ability to fully integrate the QMS and DMS processes in support of our life science business plans.”
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