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| Thought Paper |
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Best Practices for Quality Management Software Implementations
in Life Science Manufacturing |
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| Abstract |
Efficient and effective manufacturing operations are a critical component of pharmaceutical, biotechnology, and medical device operations. A company’s ability to produce a quality product without defect, rework, or investigation is central to increasing margins, maintaining service levels, controlling inventory, managing production costs, and avoiding FDA scrutiny.
A recent study on pharmaceutical manufacturing by PriceWaterhouseCoopers indicates that an exorbitant amount of capital is wasted due to poor quality management in manufacturing.
The FDA has recommended a Quality Systems model where cross-functional quality units support all manufacturing operations in their effort to comply compliance with Good Manufacturing Practices. The FDA’s motivation is not only to ensure the safety of consumers, but to foster innovative development and manufacture of products within the industry. While this concept is theoretically employed throughout the industry, the success of the implementation of this strategy can certainly be questioned based on the research cited above.
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