Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS) translates to safer products and better organizational performance and profits.
Philosopher George Santayana once stated, “Those who cannot remember the past are condemned to repeat it.” This sentiment of not learning from your mistakes holds true when building and maintaining a QMS. A QMS should continuously evolve to meet new or changing business demands and regulatory expectations. These changes provide plenty of opportunities to evaluate and improve your processes.
ProPharma Group’s compliance experts routinely observe which attributes of quality systems work well and which are a struggle for firms to maintain compliance in a regulated industry.
Eight common avoidable mistakes that stress a firm’s ability to maintain compliance with their established quality system:
Drawing from relevant regulatory authority regulations, guidelines, and industry practices, our global experts assess your QMS to identify improvement opportunities to help ensure that regulatory compliance and industry best practices are met. Our quality systems team makes sure that suitable process performance is achieved, the set of controls are appropriate, compliance opportunities are identified and evaluated, and the body of knowledge is continually expanded. With this, we focus on three primary objectives:
Whether you are proactively looking to develop and implement a Quality Management System or need to optimize your existing system, our team can help.
A proactive, phase appropriate, and risk based QMS approach can substantially reduce the risk of a catastrophic incident that could jeopardize your trial, drug, or device’s future. A robust QMS will enable you to successfully bring your product to market.
ProPharma Group’s Life Science Consulting team is made up of subject matter experts who can assist with Clinical and Commercial Quality System design including risk management, quality manuals, SOPs, CAPA design and processes, risk management plans, and communication plans. We also assist with Quality System implementation as needed. Additionally, we can conduct qualifying audits for sites and vendors, and perform routine audits for ongoing trials, CMOs, and CROs.
Whether your needs are for implementing, maintaining, or remediating a Quality Management System, our experts are here to help. Contact us today for a complete evaluation of your current QMS.
June 9, 2020
The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...
June 9, 2020
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...