A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory’s operations. Key features include—but are not limited to—workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully “support its use in regulated environments”. The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics.
Not all LIMS systems comply with GLP standards, which is essential for Pharmaceutical Researh and Pharmaceutical production companies who need to comply with FDA requirements.
One of the most cost-effective validation strategies is to follow the Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems. The Guide draws together key principles and practices and describes how they can be applied to determine the extent and scope of validation for different types of automated systems. The principles of GAMP concern five different software categories, namely operating systems, hardware and instrument embedded software, COTS, configurable systems and customized LIMS.
Following the Guide provides significant cost benefits by aiding the production of systems that are fit for purpose, meet user and business requirements and have acceptable operation and maintenance costs. The time and effort taken to achieve compliant systems is also reduced and compliance with regulatory expectations is improved by defining a common and comprehensive life cycle model. Thermo Fisher Scientific offers purpose-built or COTS solutions — such as Darwin LIMS™ for pharmaceutical manufacturing R&D and QA/QC and Watson LIMS™ for Bioanalytical laboratories — to reduce the complexity and risk of system validation.
In order to achieve validation with the minimum cost possible while also speeding up the whole project, organizations should purchase validation services only from experienced providers. The ideal vendor should be fully aware of the GLP regulations, the principles of GAMP, the validation needs of the specific application area as well as the operation and usability of the specific application software that needs to be validated. Additionally, the vendor should possess relevant information technology expertise and be knowledgeable of validation industry best practice. Finally, the vendor should comprehend the internal validation procedures of the specific organization.
Effective, timely validation can be most effectively accomplished by a validation team that has been thoroughly trained through a course that brings together the different experiences of validation approaches of the team members so that everybody agrees a common approach. Furthermore, cost-effective validation can be achieved via standardization of a single LIMS solution across all laboratory facilities of an organization or via rollout of the same system sequentially. Following one of these strategies will greatly reduce validation costs as a percentage of the overall project expenditure since only minimal acceptance testing is needed at every site and most testing can be cross-referenced.
Risk analysis may be also used but always with caution. It is true that many GLP laboratories process low risk records, however only functions, not records, can be validated. In the LIMS area it is common for the same generic functions to be used across all records, whether high or low risk. Therefore all functions must be considered high risk and subject to full validation. It can be more efficient to conduct a high-level risk analysis of the entire LIMS, which acknowledges that the whole system is high risk, rather than conduct a detailed risk analysis of every function which eventually reaches the same conclusion, but with more effort(1).
Organizations should also make appropriate use of the testing that the vendor has already carried out. For this reason, they should consider purchasing a vendor-supplied validation kit and also avoid validating functionality which they do not intend to use.
Finally, organizations should ensure that the validated state of the systems is maintained. The principles of GAMP define that this is achieved by ensuring that existing operational procedures are kept up-to-date. Maintenance of the validated state is primarily the responsibility of the system owner, and is typically achieved by defined service-level agreements with, for example, the IT function. For COTS, the vendor support package is also a vital component of the overall system maintenance.
Compliance with the principles of GLP is of high importance when registering or licensing pharmaceuticals, veterinary drugs. LIMS solutions have emerged as the most appropriate tool to assist towards compliance with the principles of GLP. Such systems can efficiently and safely record, report, store and retrieve study plans, raw data and final reports, thereby addressing the complexity of the regulations.
In order to comply with the principles of GLP, LIMS solutions need to be fully validated. This may be a particularly expensive process but costs can be considerably minimized by following certain strategies; adhering to the principles of GAMP, sourcing validation services from experienced vendors, employing a consistently trained validation team, standardizing on a single solution and ensuring long-term maintenance of the validated state of the systems.
How we can help
- We can advise you in choosing the most cost-effective LIMS for your organization.
- Where possible we make use of Open Source solutions and adjust these to meet your specific requirements.