The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in ...The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.展开更多
计算机化认知行为治疗(computerized cognitive-behavioral therapy,CCBT),即指通过电脑交互界面,以清晰的操作步骤,高度结构化的多种媒介互动方式(如网页、漫画、动画、视频、声音等)来表现认知行为治疗基本原则和方法的治疗方式。抑...计算机化认知行为治疗(computerized cognitive-behavioral therapy,CCBT),即指通过电脑交互界面,以清晰的操作步骤,高度结构化的多种媒介互动方式(如网页、漫画、动画、视频、声音等)来表现认知行为治疗基本原则和方法的治疗方式。抑郁症的CCBT近年来在西方崭露头角,目前Beating The Blues、MoodGYM、E-Couch和Good Days Ahead等抑郁症CCBT程序在西方使用较为广泛。从可行性分析上发现,该疗法较受病人接纳、具有较高的成本效用和易用性;现有实验研究证明了抑郁症采用CCBT是有效的,但其有效性仍取决于诸多因素。以往研究存在着较少关注治疗有效性的内在机制、治疗效果差异较大、风险评估简化和被试选择偏向等问题,建议未来研究应加强:(1)中介效应及机制研究;(2)以人为本的个性化服务研究;(3)风险评估与隐私保护研究;(4)在"弱势群体"中的研究与运用。最后,对其在中国发展的必要性与可行性进行了展望。展开更多
文摘The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing.
基金国家重点基础研究发展规划(973)(the National Grand Fundamental Research 973 Program of China under Grant No.2003CB716101)国家自然科学基金重点项目(the Grand National Natural Science Foundation of China under Grant No.30730036)
文摘计算机化认知行为治疗(computerized cognitive-behavioral therapy,CCBT),即指通过电脑交互界面,以清晰的操作步骤,高度结构化的多种媒介互动方式(如网页、漫画、动画、视频、声音等)来表现认知行为治疗基本原则和方法的治疗方式。抑郁症的CCBT近年来在西方崭露头角,目前Beating The Blues、MoodGYM、E-Couch和Good Days Ahead等抑郁症CCBT程序在西方使用较为广泛。从可行性分析上发现,该疗法较受病人接纳、具有较高的成本效用和易用性;现有实验研究证明了抑郁症采用CCBT是有效的,但其有效性仍取决于诸多因素。以往研究存在着较少关注治疗有效性的内在机制、治疗效果差异较大、风险评估简化和被试选择偏向等问题,建议未来研究应加强:(1)中介效应及机制研究;(2)以人为本的个性化服务研究;(3)风险评估与隐私保护研究;(4)在"弱势群体"中的研究与运用。最后,对其在中国发展的必要性与可行性进行了展望。
