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Plowmaster
I'm the senior quality manager at a late stage start-up. (Human DNA sequencing)This company has a huge software and production IT component. (The customer receives only DATA from us, a genome map of the DNA sample they sent in.) The software department has it's own 'bug tracking' system and version release control and IT production operates fairly independently, continuously fixing, installing, upgrading, fiddling with the network, data pipeline and hardware. I'm wondering how other companies have dealt with how these departments intersect with the 'usual' CAPA and Nonconforming materials procedures. It would be nice to have everything in one system but software seems to be in a unique world for fixing the bugs that pop up daily. IT is always changing out a crashed hard drive or sending back some equipment to a supplier that didn't work. It's a fairly complex environment: Software to run all the systems, erp, LIMS, data analysis and the Sequencers, IT support of all the processes and then all the Biochemistry involved with Human DNA sequencing. If a customer has a compliant about the data received, that is an easy call, enter into the CAPA system, but the daily bug report because an imager had a registration error that gets noted and fixed within a couple hours? Or for nonconforming materials, its easy when reagents has a buffer that doesn't meet spec but when IT gets a bad drive from Dell or has trouble with two pieces of hardware that are fine but are not compatible when married together? The current solution (as we are learning ourselves what the best practice for us is) is to keep things separate and only narrow SW issues that affect multiple departments or halt production go to CAPA (and complaints if any occur) otherwise just let the SW do their bug tracker (which is a focused software CAPA really) and IT just does their own thing.
We are only one of a dozen or so companies in this market and it's very unique, but I can't imagine it is unique in a heavy marriage of Software, Hardware and Biochemistry.
I hope this post makes a little sense, it's hard to describe, but the main focus is how to (if possible) have everyone in one system and where to draw the line for SW and IT to interact with Material Nonconformances and CAPA.
Thank you,
Kendal Dinsmore
We are only one of a dozen or so companies in this market and it's very unique, but I can't imagine it is unique in a heavy marriage of Software, Hardware and Biochemistry.
I hope this post makes a little sense, it's hard to describe, but the main focus is how to (if possible) have everyone in one system and where to draw the line for SW and IT to interact with Material Nonconformances and CAPA.
Thank you,
Kendal Dinsmore