In today’s modern analytical laboratory such as a contract research organisation (CRO), a laboratory information management system (LIMS) is no longer a luxury but a necessity, critical to the management and control of laboratory data and information. Due to the rising cost in R&D and biotechnology, many companies are looking at ways to maximise efficiency and profitability in order to remain competitive
Approaches to achieve these goals include implementing LIMS and automation, deploying Six Sigma, extending facilities to the Asia-Pacific region, and increasing the amount of outsourcing to CROs. This article will focus on ways to leverage automation with LIMS and method validation software as a means to increase operational efficiency, enhance data quality and facilitate regulatory compliance.
The majority of US laboratories face the challenge of doing more with fewer resources, at lower prices, in a complex regulatory landscape, and with a constantly evolving global economy. Organisations often do not invest in automation infrastructure, instead, relying on outdated manual systems that are prime targets for audits. Not only can negative audit findings prove to be costly, but they can damage the organisation's reputation and result in a loss of business.
It is common to see CROs managing significant workloads with a series of home-grown database applications, Excel spreadsheets and logbooks.These solutions tend to be piecemeal; they often lack security, do not scale, do not integrate across steps, do not have any documentation (relying on institutional memory that can walk out the door), and are not subject to standard backup and recovery methods.The total time required for all data entry and verification tasks is rarely justified at any level of the organisation, and the lack of standardisation introduces significant flaws that audits are guaranteed to find. These manual systems are frequently plagued with transcription errors, large Excel sheets that are prone to corruption, as well as a lack of an audit trail and accountability. In addition, there is often no quick or easy way to view trends in data, extract any business intelligence or have the ability to automatically generate reports, such as a Certificate of Analysis
Christine Paszko of Accelerated Technology Laboratories Inc, and Jennifer W Weller at the University of North Carolina at Charlotte