Process manufacturers need better flows of information to make timely decisions to efficiently run their businesses. The ANSI/ISA-95 Manufacturing Enterprise Systems standard, commonly referred to as S95, is the international standard for the integration of enterprise and automation systems. This global standard consists of models and terminology for the exchange of information between systems for sales, finance and logistics and systems for production, maintenance and quality.
One key area of information flow is reading laboratory analysis results from the laboratory information management systems (LIMS) and coordinating this information with the running batch controlled between the batch automation system and the manufacturing execution system (MES). The MES normally maintains the complete electronic batch record of all automated and manual processes, including LIMS data.
I spoke with Steve Thorp, an Integration Consultant in our Life Sciences industry organization. He is currently working with a batch process manufacturer who is implementing extensive elements of the S95 model, including comprehensive LIMS integration. Some of the key objectives for this project included:
- Providing the MES system (Compliance Suite for this project) the ability to request the creation of new samples within the LIMS system based on the current status of the MES Electronic Work Instructions. The MES system would also read information from the process control system to determine when and what samples would be created.
- Providing the MES system the ability to monitor the status of specific samples within the LIMS system
- Providing the MES system the ability to read the analysis results for specific samples within the LIMS system after the samples status has been set to “completed”
Steve and the team architected and implemented a solution which first combined the LIMS server software and MES server software onto a single hardware platform using one SQL instance, with separate databases for the LIMS and MES data. Next the LIMS and MES clients shared the same network and often the same PCs running both clients. The team developed scripts using the MES Electronic Work Instructions to have the MES software execute the LIMS software to have the laboratory analysis data entered per the appropriate work instruction, and then automatically inserted into the proper area of the LIMS database which feeds the electronic batch record.
Steve talked about the alternative of doing this process manually, the number of people who can be involved, and the delays this manual process can cause to the release of the batch. By analyzing this processes and architecting a solution to automate the manual pieces, big efficiencies can be gained.
For implementing this portion of the S95 model Steve offered the following guidance to process manufacturers. First, fully understand the current workflow including how and when the physical samples are taken, when the results are required, how these should be included into the electronic batch record, and what failure contingencies should be made in the MES and automation system if the results are not ready when expected. Second, when implementing the design, it critical to understand the underlying data structure within the LIMS system, and to understand the overall usage patterns to properly estimate server and storage requirement for the hardware design.