ABSTRACT
Effective and efficient utilization of assets by pharmaceutical research or manufacturing enterprises is fundamental to the early delivery of new products to market and to satisfying customer demand once those products have been approved for release by the relevant regulatory authorities. Effectiveness and efficiency must be established from the outset of asset specification and design (“built-in quality”) and cannot be delivered by fine tuning and testing (“testing in quality”) when the asset is handed over from the development environment to the operational environment. Assets must be reliable, consistent and capable, that is, they must
• be available when needed and not fail during use;
• function consistently to predefined performance criteria; and
• meet performance criteria without undue stress, risk of failure or reduced asset life.
