Laboratory 2000 ‐ The challenge of achieving efficiency and compliance

Abstract

Significant advances within the field of laboratory automation and instrumentation have greatly benefited the pharmaceutical industry in its quest to discover, develop and monitor the quality of its products. Necessitated by the need for efficiency and greater productivity, faster and more cost-effective means of analyses exist in the form of devices made up of complex electromechanical components, all logically controlled and most with the capability to interface with sophisticated information systems. This benefit does come with a price, a greater responsibility to ensure data quality while complying with increased regulatory requirements. Commitment to this responsibility presents a substantial challenge to scientists and managers throughout the industry. Due diligence must be demonstrated. A comprehensive evaluation of every laboratory system utilized, a solid plan of action for correcting any known deficiencies including upgrades or complete replacement, and an accurate monitoring procedure with the ability to measure progress are all absolute necessities to ensure success. Crossfunctional team effott and communication must transpire with full managerial support. Vendors need to be audited, made aware of any functional or quality inadequacies they possess as well as the pharmaceutical industry's expectation for these shortcomings to be rapidly corrected. Suppliers of these systems should also be encouraged to provide complete ‘off-the-shelf solutions’ to eliminate the need for in-house customization. The requirements for regulatory compliance in today's electronic environment have been well publicized. The players involved are not only listening, but also taking the necessary steps to retain and improve efficiency without sacrificing quality. With the proper measures, planning and action, a highly automated, cost-effective and compliant laboratory operation can become a reality.