Time spent gathering and analyzing data from multiple sources is the biggest challenge facing both small/medium and large drug makers, say respondents to a recent survey. In addition, more than 60 percent of 538 manufacturing professional respondents report "moderate" or "significant" variability in their manufacturing processes.
Results indicate that more than half of small/medium companies use home-grown data aggregation systems, while large companies more often use data historians and data warehouses, reports Aegis Analytical, which conducted the survey.
The analysis finds that "data aggregation frustration" affects not just batch investigations but also regulatory audits and annual product reviews. The overall survey finding is that existing IT investments are not being leveraged. Large companies that have invested more heavily than their smaller counterparts in IT infrastructure, but even those using lab, manufacturing and enterprise software systems still report spending too much time collecting data.
Consultant Michael McClellan, writing in our op-ed section, says "what is needed is an easy method to extract data from each information source to build an electronic file to match the master batch record format." He has a project underway to do just that.
- access the survey report here [1]
- click here [2] to learn about McClellan's project
Links:
[1] http://www.aegiscorp.com/lifesciences_survey_signup.asp
[2] http://www.fiercepharmamanufacturing.com/story/needed-faster-easier-master-batch-records/2009-06-15