A variety of factors are contributing to a new level of complexity in relation to how the life sciences industry is managing its quality processes to remain in compliance. Some of these factors include: the increasing portfolios of products under management, the degree to which companies are outsourcing key services and the evolving regulatory compliance environment. The risk to a company, whether it's a pharmaceutical company or a medical device company, is too great to manage in an ad hoc way and thus an integrated format is required to facilitate a sustainable approach that will assure the value of the company's product assets.
Today these approaches must provide nimble as well as efficient and compliant solutions, otherwise they will either add unwanted costs or not meet the expectations of the industry and the International regulatory bodies. Risk is a huge factor and the ICH Q 9 guidance (Quality risk management) sets out that every element of Quality Management should contain a Risk assessment and Mitigation function. Failure to meet these requirements and other regulations such as 21CFR parts 210/211, 21CFR part11, ICH Q 10 Pharmaceutical Quality Systems and ICH Q8 Pharmaceutical Development, can result in severe penalties by the agencies, resulting in citations (FDA 483), Warning Letters and Consent Decree actions. The impact of these increasingly severe actions is a loss of brand equity in the market place which damages the company's competitiveness. The way forward then is to develop a sustainable integrated approach that will address each of these major points and in doing so maintain the company's regulatory compliance position without paralyzing the business operations.
Join Nigel Smart, Managing Partner, Smart Consulting Group on this exclusive webinar hosted by MetricStream that will discuss the enterprise-wide approach organizations can adopt to ensure quality management processes are aligned to regulatory compliance goals and the role technology can play to obtain a 3600 view of its Quality Management processes for a sustainable compliance program.
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