Although the pharmaceutical industry has pioneered information technology as a research and development tool, it has consistently lagged behind other industries in using technology to automate and streamline manufacturing processes. Although in some cases, massive investments in drug discovery technology have yielded successful new products, inefficient production processes have prevented companies from meeting market demands quickly and cost effectively.

As the US Food and Drug Administration's Center for Drug Evaluation and Research has observed, "While Americans have the highest quality of drugs in the world, the process used to produce them can be expensive and wasteful" (1). Government and industry initiatives addressing this problem attribute much of that inefficiency to limited automation and point to manual recordkeeping and information collection as major contributors leading to the industry's poor manufacturing-efficiency record. Meanwhile, the pharmaceutical industry accepts equipment use rates that hover below 40%, a figure no other major industry tolerates, and batch quality failures range from 5 to 15%. With batches worth as much as $1 million apiece, these failures add up to significant loses. By comparison, the semiconductor market, which dealt with similar process problems 25 years ago, currently maintains waste well below 1%.

The industry's manufacturing inefficiency is a result of three factors:

• poor process understanding and control, which causes lower yields and production delays as a result of subsequent quality control procedures;
• inefficient, voluminous, paper-based production workflow, which produces very slow set up, production, verification, and so forth;
• the chronic uncertainty of demand in the consumer market.

FDA identifies process analytical technology (PAT) as the best means for improving pharmaceutical industry production processes. FDA defines PAT as "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality" (2). In other words, PAT is a form of in-line quality control that allows small, real-time adjustments to be made to a batch to maintain its quality and keep its expected process completion on schedule.

PAT is a parallel effort to the longer-established electronic batch record (EBR) movement, which focuses on using one or more network-based computer systems to replace paper batch records. In the same way that PAT makes production more efficient than the typical postprocess quality inspection, EBR makes regulatory compliance more efficient by consolidating and organizing data that companies once had to manage manually with paper. PAT systems themselves produce critical electronic batch records.

PAT and EBR both require highly reliable point-of-production data collection and data processing. The EBR system cannot have any breaks in the regulatory record chain or the batch in question must be discarded. PAT requires manufacturers to record process data as well as the adjustments that are made to ensure batches viability. PAT and EBR applications must operate in a continuous manner to electronic record gaps that reduce their value-add to virtually nothing. Without combined continuous availability of computer, network, and storage systems, PAT systems could be less useful than manual processes.

Although forward-thinking companies are considering adaptation of PAT and EBR systems, most are unaware of how heavily these systems depend on continuously available information system infrastructures. This article examines the current pharmaceutical IT landscape, including how PAT fits into the picture and how a continuously available infrastructure is the mandatory foundation of a PAT implementation.