Many life sciences companies are embarking on a laboratory digital transformation journey and are using a LIMS solution to help them reach their destination. In order to realize how LIMS can be the center price of a digital transformation, we first need to understand the fundamentals of what such a transformation looks like for a laboratory.
What is a Laboratory Digital Transformation?
Although paper documentation is “king” in the laboratory, nearly every laboratory process presents opportunities where manual paper processes could benefit from a digital transformation. For example, samples are entered into a paper log book upon receipt into a laboratory, testing is documented in a laboratory notebook or approved form, the analyst prints raw data for report and review, finalized results are generated in a paper-based Certificate of Analysis, and sample disposal is recorded in a paper based log book as well. Secondary processes like stability testing, instrument usage, standard and reagent management and equipment maintenance are again documented on paper. All this information could be recorded electronically, eliminating the need for paper.
The critical elements of a digital transformation for a laboratory include:
Electronic Integration – the implementation of the laboratory processes into electronic enterprise systems.
Process Automation – the elimination of manual processes, reducing paperwork, and increasing process efficiencies and overall throughput.
Equipment and Instrument Interfacing – the interfacing of various equipment and instruments to input results, whether analytical data, raw data files, chromatograms or scans.
Collaboration – to foster and increase the interaction and communication throughout and across the labs.
Real-Time Data Access – providing immediate access to data electronically, which aides in providing results for data driven business decisions.
What are some critical steps to take towards making the laboratory more digital?
Create a Roadmap – A roadmap or multi-phase plan is a high-level overview of the digital transformation vision and direction over time. The roadmap shows the overall strategy and anticipated effort required to achieve the objectives.
Develop an Implementation Plan – The implementation of the digital laboratory requires a well thought out business case, and a deployment plan with supporting capital budgets.
Harmonize Processes – This will be vital to getting the most out of your digital transformation. The more processes that can be aligned across the labs, the better electronic and communications tools can be leveraged.
Deploy the Solution – The solution should consider implementation and integration of LIMS, electronic laboratory notebooks, laboratory electronic systems and chromatography data systems. Further integration with other infrastructure systems should be considered as well, such as Enterprise Resource Planning, Quality Management, Equipment Management, and Learning Management.
With any new way of doing things there will always be challenges, but by defining and maintaining your strategic objectives, effective resolutions to these challenges can be identified.
A Note on Global Harmonization
Mergers and acquisition or different technology strategies can lead to dynamic, site specific business processes and laboratory information management systems configurations. In these instances, a more global approach may need to be taken to your digital transformation and LIMS implementation to drive harmonization. In these instances, a robust core solution that meets the needs of all the sites in the network must be established.
Please download Clarkston’s Laboratory Digital Transformation webinar to view our perspectives on LIMS being the centerpiece to digital transformation and the global harmonization process.
Additional contributions from Ben Gaise, Segun Olorunyolemi, Lynette Nazabal, and Mike Lanewala