We already knew about Q-Pulse and recognised that the software offered could meet our needs and requirements. By having the robust 21 CFR Part 11 enabled in our system also, we can easily meet our GCP requirements.
Lloyd Gregory
Associate Director of R+D
Through their commitment to improving patient health, NHS SalfoR+D recognised a need for an efficient electronic Quality Management System, helping them manage their compliance activities to comply with MHRA regulations.
Based in Salford, NHS SalfoR+D specialises in Acute and Primary Care Research and also runs Good Clinical Practice (GCP) trials to develop cutting edge treatments and improved methods of care.
NHS SalfoR+D required a QMS system which would allow them to move from their manual paper-based methods to a central, electronic system for their compliance needs. Q-Pulse, developed by Gael Ltd, was chosen as the most effective and efficient system.
Lloyd Gregory, Associate Director of R+D, said: “We needed a system that would allow us to streamline our compliance activities which included Document Management, Audit and Training.
“We had previously been managing these activities using manual processes and required software that would allow us to easily log our information electronically, taking away our laborious manual method.
“We already knew about Q-Pulse and recognised that the software offered could meet our needs and requirements. By having the robust 21 CFR Part 11 enabled in our system also, we can easily meet our GCP requirements.”
NHS SalfoR+D will use a number of Q-Pulse modules to help streamline and manage their compliance activities that include Documents, Training, Audits, CAPA and Assets.
Lloyd added: “We were very keen to put in place proper controls for our Document Revision management process that included issuing and approvals. It was also essential that we recorded our training processes against our Standard Operating Procedures (SOPs).
“The system will help us do that, and enable us to show the MHRA how we are managing both areas efficiently. It also gives us the tools to manage our internal audit programme more effectively using the CAPA module to track findings and resolutions better.”
For further information please contact:
Michele Agnew
Marketing Director
Gael Ltd
+44 (0) 1355 593400
michelea@gaelquality.com