The Duke Human Vaccine Institute, a component of Duke Health, is to implement software from Ideagen to assist with quality management for an HIV vaccine manufacturing programme.
Ideagen Q-Pulse will help staff catalogue and manage equipment maintenance and calibration records, training record logs, audits, deviations and corrective actions as part of its quality management system.
Q-Pulse will also assist in the monitoring and management of vendors and change control and integrate risk assessments and risk mitigation through its risk and incident management functionality.
Dan Ozaki, Quality Manager of the HIV vaccine programme, said: “Q-Pulse will help to organise and facilitate the quality management programme that we are implementing.
“It will allow us to address key processes and manage aspects of quality electronically compared against our previous paper-based systems, which required a lot of staff time and effort.
“We believe Q-Pulse will be helpful for quality management in our HIV vaccine manufacturing programme. By using its IMS functionality we will be able to integrate risk assessment and risk mitigation and link our incidents and occurrences, deviations and CAPAs.”
The HIV vaccine manufacturing team will assess early phase clinical material manufactured for first-in-man and proof of concept clinical trials.
Duke’s manufacturing programme is just one unit utilising Q-Pulse at Duke University Medical Center. Q-Pulse is also used in other departments in the medical centre with around 350 users using the system as a foundation for quality management for Good Clinical Laboratory Practice compliance.
Ideagen is a UK company quoted on the London Stock Exchange AIM market. It provides quality, safety, audit, performance and risk management software and expertise and has operations in the UK, the European Union, the United States and the Middle East.
Q-Pulse is Ideagen’s proven quality, compliance, safety and operational risk management solution for thousands of organisations globally.