Matthew Kopecky

This year witnessed a revitalized awareness in the importance of quality management at global biopharmaceutical organizations. Organizations took stock of potential risk factors of insufficient quality initiatives across all departments and, consequently, enterprise-wide quality management has become a top priority for both companies and their stakeholders.

Although regulatory policies are clearly designed to protect the public from undue harm, unless handled in an efficient manner, they can also consume a biotech organization's limited resources and lead to production delays, inflated costs, and lower profitability.

To stave off quality issues associated with production processes and procedures, companies should implement and enforce a centralized and enterprise-wide quality management initiative. Enterprise software systems can help provide this level of management and control while improving productivity, increasing time-to-market, reducing production costs, ensuring compliance, and ultimately reducing risk.

When implementing a centralized quality management initiative, there are a number of factors to consider, especially in terms of management visibility, product improvement, and process efficiencies. An efficient quality management system must offer the following:

Visibility into trends, improvements, and risks

• Streamline processes for decision-making
• Standardize quality process workflows and escalation procedures at the corporate level while executing these at the department level
• Collect supplier, factory floor, and customer quality data automatically, and leverage these as actionable intelligence
• Provide visibility across the value chain to improve safety and operational integrity
• Afford real-time interoperability with other business applications.

Product improvement

• Foster best-practice quality performance through automation of quality processes
• Build compliance and traceability into processes
• Streamline workflow
• Ensure efficiency for shorter cycle times
• Eliminate the need for multiple IT systems
• Synchronize quality and manufacturing
• Manage partners and suppliers, and monitor their quality and compliance conformance.

The biotech world is constantly evolving and new technologies and discoveries, process enhancements, and system improvements are introduced each year. To stay ahead in this dynamically evolving marketplace in 2009 and beyond, forward-thinking organizations need to arm themselves with the tools and pragmatic quality management approaches necessary to balance compliance with continued innovation. Furthermore, as these organizations expand their businesses and operations, enterprise-wide quality control becomes more vital—to proactively identify and address the key issues affecting supply-chain quality management before these issues become a threat to business growth, the company's bottom-line objectives, and continued biotech innovations.

Matthew Kopecky is a product manager at Sparta Systems Inc., Hamilton, NJ, 732.203.0400, matthew.kopecky@sparta-systems.com