Cleanroom management: Information technology offers a compliant roadmap for quality

摘要

Pharmaceutical manufacturing organizations face the challenge of balancing resources to meet and maintain current good manufacturing practices (cGMPs) compliance expectations with their need to continually improve the efficiency of operations. With proper planning and attention to core business objectives, information technology (IT) solutions can help organizations achieve a proactive and sustainable approach to: 1. Compliance with cGMP mandates and validation requirements, with particular attention to Part 11 requirements. 2. Timely and targeted information and feedback systems for Decision Support. 3. Increased operational effectiveness & productivity. However, these three criteria quickly become competing forces as manufacturing operations deploy IT solutions. If investments in technology and automation are not balanced appropriately, manufacturing organizations may not be able to remain competitive while meeting quality mandates.