A custom-build LIMS eliminates time-consuming customization process, which is crucial to the pharma industry.
FREMONT, CA: A laboratory information management system (LIMS) has been designed to support a modern laboratory’s operation. A custom-built LIMS that has the option to embed various modules enables cutting-down of the lengthy customization process. As operating procedures and industry workflows determine functionality, platforms are designed to meet needs before implementation processes even begin. Such an accelerated start has various advantages:
Against a more typical LIMS system, a customized LIMS can deploy 75 percent faster. Its customized functionality enables a consistent, industry-standard workflow that allows labs to achieve better efficiency and productivity.
Faster deployment and improved functional efficiencies allow significant cost savings. Replacement of stand-alone ELN and LES products and other point solutions with fully embedded, pre-packaged modular capabilities in a streamlined platform allows maximizing to return with time.
A custom-built LIMS utilizes industry latest compliance, best practices, and regulatory developments. Thus, it eliminates the requirement for custom code and reduces the configuration effort. It reduces the risk, which is inherent with other LIMS project.
In case of a custom-build LIMS, lab managers can disable or conceal functionality. It results in a user experience which is focused on the particular industry as well as to the requirement and applications of front-line staff. Thus, productivity is increased, training time is reduced, and the overall quality is improved.
Industry conditions and regulations change with time. Thus, labs are likely to change as well, especially with the addition of new users, service areas, or new tests as the business expands. A purpose-built, modular LIMS that utilizes industry-standard web technology can expand with the business, from start-up labs to global operations. It is feasible without the prohibitive cost, time, and compliance issues that result from specialized coding.
Built Better for Pharma Labs
Compared to several other industries, compliance and traceability guidelines are more stringent for labs in the pharma industry. It is especially the case as regulators turn their focus to the question of temporary memory.
WHO updated its stance on data integrity within its Guidance in 2014 on Goods Data and Record Management Practices report. The MHRA and FDA followed suit soon after draft guidance called for the permanent seizure of all data generated. It is required to satisfy a CGMP requirement. Thus the drug manufacturers need to consider a tighter data integrity standard with new tools. A web-based, new data auditing functionality that is optimized for use in pharmaceutical labs is the demand of time.
Data Auditing Functionality Compliance
A purpose-built tool which is designed to help drug manufacturers adhere to existing and proposed data integrity guidelines from the MHRA, the WHO, and the FDA. Such a tool should help in the lab to capture a clean, complete, GxP-compliant audit trial, which includes:
• Changes in temporary memory
• Changes in data
• Date and time of data entry
• Electronic signatures and mandatory reason for changes
• Identity of the person inputting the data
Challenges in Pharma Laboratories
The primary challenge while selecting a LIMS in pharma is the wide range of laboratories in a company. Screening, combinatorial chemistry, clinical and preclinical bioanalysis, production quality control (QC) and manufacturing R&D, each has unique workflows and needs. However, end-user searching a solution to their business requirements are often challenged by higher management to accomplish their tasks somehow with a system which is already in use in any other part of a company. It can work in some cases, but more often, the outcome is a failed implementation, with several unhappy users.
Complex test methods with multi-stage acceptance criteria must be extensively automated. Product testing in the pharma sector is highly batch-oriented. Thus, a potential solution for the manufacturing area must incorporate batch management capabilities. Clinical and preclinical bioanalysis is highly protocol-driven. It is crucial to understand the study protocol before designing the solutions for these laboratories. While some may consider this approach as contrary to the industry-wide trend of standardization, the fact is it is only beneficial to standardize if it’s advantageous to do so.
Intense regulatory scrutiny is another widely recognized reality for the sector. Any potential solution must address the concerns of both static data such as study protocols and product specifications, and dynamic data like batch dispositions and test results.