The convergence of ELNs and LIMS

The demands of compliance-based processes in the life science industry has created specific requirements to capture, catalogue, review, approve and present data used in quality decision-making for drug products.

VelQuest addressed these demands in 1999, by developing an electronic process management and compliance platform (ePMC) and a purpose-built cGMP Electronic Notebook primarily for QC/QA operations in pharmaceutical manufacturing.

A critical element of the electronic notebook was the integration of lab workflow method/documentation tasks and the integration of all laboratory instruments and devices into the system for compliant ‘real-time’ data capture. Being in quality control, the expected norms for each data element could be specified (in the method) and therefore the system could automatically check the experimental result and compare it to the expected values and so alert the analyst should their experimental values vary outside of the acceptable range.

These specific cGLP/cGMP lab automation capabilities were introduced into an existing laboratory informatics management system (LIMS) environment.

Now, many leading life science companies are stepping back and looking at the next decade and are actively planning to ‘harmonise’ their global cGMP IT systems. Their goals are to gain significant productivity improvements, cost reductions and improved infrastructure dynamics through a clear and compelling convergence strategy.

For some this is resulting in a three-tier structure with SAP, a thin-LIMS and a cGMP Electronic Notebook System. The LIMS layer is being completely eliminated by utilising the QM module of SAP and the administration modules in the cGMP ELN. Reported results include >20% cost/productivity improvements, >50% cycle time reductions, the elimination of paper in the process and assured compliance documentation.

Alternatively, some companies are implementing a two-tiered system with direct interface of the cGMP LES/ELN with the QM SAP module, thus eliminating the need for a commercial LIMS altogether.

In this architecture the lab administration layer tasks are limited to key management level operations (specifications, lot and sample input and reporting), thus eliminating the ‘customisation’ and costs required to integrate the LIMS with lab workflows, instruments, lab procedures and the important metadata pedigree needed for compliance documentation. The ‘lab workflow layer’ is then centralised within the GMP Electronic Notebook layer and fully integrates with all lab instruments, methods, supplies and analysts.

The convergence of IT systems in cGMP quality operations

From recent industry press reports, it is clear that to survive and thrive in the 21st century, pharmaceutical, biotechnology and generic cGMP operations and their associated partners (CROs and CMOs) must find ways to cut costs, improve productivity and reduce compliance risks. Historically, many IT groups have focused on a LIMS strategy to attempt to automate workflow processes in the QC/QA lab environments. In reality, the traditional LIMS implementation only satisfies some (but not all) of the management needs.

A clear recent trend in many cGMP quality groups interested in harmonising their entire global IT infrastructures from the ERP system down to the choice of lab instruments is the wish to minimise the number of systems and vendors. Accordingly, they are seeking to meld LIMS functions and ELN functions into a common platform.

The convergence of LIMS and ELN technologies is happening today.

After over a decade of implementations in pharma, biotech, generic, CRO and CMO operations, the current observations on industry demands centre on ‘harmonising’ the IT infrastructure on a global level. This demand is to minimise the ongoing total cost of ownership issues of deploying multiple IT technologies (ie, ERP, LIMS, ELNs etc). VelQuest has created a holistic technology platform (ePMC) that provides both LIMS and ELN functions with cGMP specificity that can be easily and quickly integrated within any current cGMP IT infrastructure. This platform reduces the total cost of ownership issues and assures compliant method execution, data capture, documentation and data transport to other IT infrastructure needs (ie, SAP).

Virtualisation and cloud computing

Technology by its very nature is constantly in motion. On the IT informatics front, some interesting potential infrastructure design opportunities point towards virtualisation and software as a service or ‘cloud computing’.

Technology advances in communications, computation and storage result in huge collections of data, capturing information of value to a cGMP quality organisation. In the discovery and/or R&D areas, data volumes are currently growing faster than Moore’s law. Looking forward, the exponential growth is not likely to stop. The huge size of the data are imposing infrastructure issues for data storage, which can achieve economical scaling to even Petabyte levels, massively parallel query execution, and facilities for analytical processing/visualisation. In the pharmaceutical manufacturing arena, the actual amount of quality data is miniscule by comparison; however, the data along with the compliance required metadata do add up. The prospect of eliminating or at least minimising the IT infrastructure footprint can be a substantial TCO consideration.

Meanwhile, the development of data centres and cluster computers has created a new implementation model, cloud-based computing, where one can rent storage and computing capacity, rather than making the huge capital investments needed to construct and maintain large-scale computer installations. Cloud-based data storage and management is a rapidly expanding business. While these emerging services have reduced the cost of data storage and delivery by several orders of magnitude, there is significant complexity involved in ensuring large data service can scale when needed to ensure consistent and reliable operation under peak loads. The cloud-based environment has the technical requirement to manage data centre virtualisation, lowers cost and boosts reliability by consolidating systems on the cloud. In addition, in an ideal world, the cloud systems should be geographically dispersed to reduce their vulnerability due to catastrophic events, which increase the technical challenge on a great level of distributed data interoperability and mobility.

For those interested in more information, VelQuest Corporation released a position paper ‘The Convergence of Electronic Laboratory Notebooks and Laboratory Information Management Systems in cGMP Quality Operations’ in July 2011. The complete paper can be obtained by emailing info@onqsoft.com.au.