I saw a tweet yesterday, which pointed to a great BioProcess International article, Biopharmaceutical Information Infrastructure 2.0 (Part 1 of 2). I sent the link to Emerson’s Jonathan Lustri, who manages the Syncade smart operations management brand for his thoughts. I thought they were great and needed no further elaboration from me. Here’s what he wrote back:
Regarding information management within a Biopharmaceutical operation, this article does a nice job of laying out information about data collection and visualization for postproduction analysis. Systems that do this may generally be categorized as manufacturing intelligence (MI) systems.
This is all well and good for applications where engineers and quality assurance (QA) people want to perform analysis on how to improve the process or investigate what went wrong. It misses all together the opportunity to use information to prevent errors and assure manufacturing efficiently. In order to truly gain benefits to eliminate human error and speed QA review and approval, information has to be applied within the context of performing manufacturing procedures.
So in addition to all of the points made in this article, biopharm processing should consider software systems that electronically dispatch work procedures to operating personnel and bring to them the information they need to correctly perform the procedure. In most Biopharm facilities, work procedures are coordinated with paper standard operating procedure (SOP) documents and Batch Production Records.
Depending on personnel to read paper instruction, correctly follow these instructions, and then manually record key information by hand in paper batch production records affords huge opportunity for error. Furthermore, even if a site has a well-developed manufacturing intelligence system, all the information recorded on paper either never makes it into the MI database, or requires the information to be transcribed at a later point.
There are software systems now available, such as Emerson’s Syncade Smart Operations Management suite that include workflow engines that dispatch step-by-step work procedure guidance to operators to direct them how to perform the procedure. And, through integration with other systems, information can be brought to the operator within the context of the procedure to assure efficiently performing the procedure.
For example, a sampling operation may require a sample ID from the laboratory information management system (LIMS). By using a workflow software system to guide the operator on the steps to take the sample, we can increase the likelihood the procedure will be performed correctly and we can automatically provide the technician the sample ID if the workflow is integrated to the Lab information system and even automatically print out the sample bar code label.
Another value workflow execution systems can bring is in the coordination of work activities. If quality manufacturing requires two operators to perform different tasks which need to be coordinated, using paper-based batch records, such coordination can only occur by two technicians talking together to verify things are coordinated.
The result is that they may not talk and the activities may occur uncoordinated. Using a workflow execution system, the workflow engine performs the coordination and only dispatches work activities at the point in time they should be performed.
To summarize, data collection and visualization information systems for manufacturing intelligence provide significant value in postproduction analysis for investigations and process understanding. The biopharm industry should also look to workflow software systems to apply information within the context in process procedure execution.
The primary benefits of this are that it enables truly paperless operations, eliminates human error and increases productivity by eliminating many manual information look up steps.
It makes sense to reduce errors by automating the workflows where possible and practical.