Digital transformation of laboratory operations

Managing Consultant, Decision Design, NNE

Leif Poulsen

Managing Consultant, Decision Design, NNE

Leif Poulsen is an expert in business analysis and conceptual design of automation and IT solutions, including how to deploy such solutions effectively in a GxP regulated environment. As a subject matter expert within automation and IT, his focus is on manufacturing execution systems (MES), advanced automation and IT solutions and how they can support current and future business objectives. 

Leif Poulsen is member of the ISA SP88 Batch Control CommitteeISA SP95 Enterprise/Control Integration Committee and a member of the GAMP Forum. In 2011, Leif Poulsen was awarded the ISA ‘Excellence in Documentation Award’ for his article on deployment of MES in the pharmaceutical industry. In 2013, he was certified as a TOGAF Enterprise Architect.

Today still most of the development and production laboratories in the pharmaceutical industry are operated in a manual/semi-automatic way and burdened with tedious paper-based documentation. The frontrunners in the industry have however started a digital transformation of lab operations to increase efficiency and decrease lead time in laboratories. The potential benefits are huge.

Manually operated instruments are replaced by computer-controlled instruments where plans for what to analyze are automatically fed to the instruments before execution and test results automatically sent to central systems for documentation or further analysis.

Instruments may be combined in laboratory cells with a limited number of related analytical instruments and where robots may be used to transfer samples from one instrument to another.

Transfer of samples between such cells may be handled by automated guided vehicles and tracking of samples may be handled by matrix codes or RFID chips.

To optimize the utilization of the highly automated lab instruments the lab may be supported by an advanced finite scheduling system

The analytical results may be uploaded to a central data repository where advanced data analytical tools may exploit recent developments within artificial intelligence.

A typical example of a system architecture for advanced digital operation of development labs is shown below:

Figure 1. Architecture for highly automated and integrated lab operation

Automated and integrated lab solutions can increase faster launch of products and cut down cost for development/production of products.

However, the actual solution must be adapted and aligned with company specific business objectives and strategies.

This can be ensured by development of a digital transformation strategy for lab operation as shown in fig. 2 below:

Figure 2. Model for development of digital transformation strategy