管理产品质量问题和产品合规性流程如Corrective and Preventive Actions(CAPA)是当今医疗器械制造商面对的最大监管风险来源。这一管理流程被困陷于各种材料细节之中,并未能充分解决风险、根源和整治的关键问题。医疗器械制造商和其他生命科学组织坚持不懈地有效处理质量问题,但随着产品和流程复杂化程度的增加,这一问题将继续恶化。同时,尽管医疗器械制造商收集了大量有关质量体系的宝贵反馈意见,但他们没有得到他们应获得的战略价值。
ENOVIA has proven particularly valuable in helping us model our business process, which it does very well. As a relational database, it enables our people to work through the details of a business process and apply it through a schema
Stephen Wells,
Design and Documentation Manager,
Terumo Cardiovascular Systems