Is anyone using a statistical software package like Minitab to analyze stability data in a LIMS system with a direct link to the database? We are just setting up a Labware LIMS system for stability management, and so far the only option we have is to export data from LIMS, import it to Minitab and manage the data and analysis in Minitab. I’d like to be able to link the two so that the data integrity is intact and it is a more automated process.
In my current life, no. In a past life, no, again, but we did export the data to a data warehouse and from there the statistics and reporting tools worked very well. The biggest drawback was timing. To avoid taxing the LIMS system the exports were done each 24 hours, thus the risk of data not being absolutely current was always there (although very rarely any impact). Still, if that’s what you’re referring to by data integrity, that’s the only issue I can think of, otherwise validation of exports vs. direct grabs would cover any data integrity concerns. If absolutely necessary, the outputs could be footnoted/watermarked to indicate the exact date/time of currency of the data.
That is ultimately the goal where I currently am. We are targeting JMP and our LIMS to be integrated. According to the JMP people, most LIMS should be able to integrate without issue. The folks over at JMP have been very helpful for us. Your GMP IT team should be able to setup the network infrastructure to prevent network bottlenecks.
While we setup our integration, we are generating hybrid reports from JMP (for the calculations and charts) and the LIMS for the reported results (COT and stability reports).
As Walter indicated above, these integrations require validation to ensure each system is performing their part without error and in sequence.