A legislative requirement of GxP is to have an effective Quality Management System (QMS) in place. The QMS should be all encompassing, with a complexity consistent with the activities being undertaken. Unique to your company and culture, the system must set out your processes, procedures, responsibilities, and risk management principles. In addition to being maintained, this system should be iterative, enabling learning through feedback and continuously improving. QA+ has successfully built a number of Quality Management Systems of varying complexity. The bespoke QMS can be built as a standalone system or incorporate your current international or corporate systems. Our diverse experience as a consultancy, enables us to build and develop a system that works for you.

Quality Events is a collective term we apply to risk management, deviation handling, control of change, corrective and preventative actions (CAPA), complaints management, returns assessment and recall activities. As the overall control strategy built into your company’s quality culture, these events are critical in managing and improving your quality system.  Quality events must be reported, documented and investigated, and as an indicator of the health of your quality management system, these events are of particular interest to regulators. They allow the review of risk, corrective and preventive actions to be applied, and the effectiveness of the system to be reviewed frequently. Within QA+, we can support with your quality events, from providing interim support or advice to managing your quality events systems.