Quality Assurance
BECAUSE IT HAS TO BE RIGHT
Highly developed quality systems - effective whilst not restrictive.
The effectiveness of MAC’s QA system is confirmed by external audit metrics. In the last 5 years, we have received 34 Sponsor Audits, all of which have returned only minor findings. The last MHRA audits in Aug 2016, Aug 2017, Aug 2018 and Dec 2019 reported no critical findings. These audits confirm compliance to UK regulations which include GCP in our clinics and GMP in our manufacturing unit. Quality issues from any source go through a process of root cause analysis and subsequent implementation of corrective and preventative actions (CAPA).
MAC has around 100 SOPs and policies that are adaptable and flexible that allows us to work globally, to which every MAC team works closely. These cover both early and late phase clinical operations, centralised services, Biometrics and the GMP production unit. Adherence to authorised procedures across teams is monitored by managers and regularly audited by QA via study-focused and system audits. Document control is managed centrally, extending from SOPs to study-related or supporting documents and company policies. Procedures can be revised quickly, without the onerous process sometimes encountered in some of the larger organisations. The QA department has an independent position within MAC, as illustrated below:
The QA department comprises 5 staff with an independent position within MAC and has 30+ years’ of experience, working actively with operational management to provide quality solutions for the whole business. This has proved a rewarding partnership. The Head of QA is regularly involved with the RQA (Research Quality Association) in training and networking initiatives and sits on the RQA board. Auditing is strongly supported by advice and facilitation, adding considerable value to the process. Staff are regularly trained and coached on critical areas requiring quality compliance. GCP training is also conducted periodically on all staff. Customer feedback is obtained from Sponsors, Monitors and Patients, then trended and shared with senior managers. Mean satisfaction scores from all sources are currently running at better than 90%.