Life Sciences Motivations for EQMS Implementation: Non-Conformance, Risk & Compliance
Industry News - 10 December 2013
LNS Research in Cambridge, MA recently published a survey (LNS Research, The Global State of EQMS, 2013) on manufacturers that have automated their quality systems. The survey results, compiled from more than 500 responses from manufacturers in various industries, reveal a number of interesting drivers that motivated them to take on this initiative. For purposes of our blog, we will focus exclusively on the Life Science respondents, who accounted for 18.8% of all received responses.
Among Life Science manufacturers it was made clear that the over-arching motivations for automating their quality processes were to avoid non-conformances, avoid operational risk and to ensure compliance with regulatory requirements. This conclusion was in contrast to respondents from manufacturers outside of the Life Science industry where the primary motivations appeared to be associated reduction in the overall cost of quality.
The most important motivator for automating quality processes among Pharmaceutical Manufacturers and Medical Device Manufacturers was ‘Reduction of Non-Conformances in Manufacturing’ (cited by nearly 30% of respondents). The next most important motivator for Pharmaceutical Manufacturers among those respondents was ‘Ensured Regulatory Compliance’ (>25%). Among Medical Device manufacturers, it appears that Improving the Customer Experience was an important driver as well (cited by nearly 20% of those responding).
Having said that, the value of implementing an automated quality system as a tool to help reduce the total cost of quality is not lost on manufacturers in the Life Sciences; however, it appears that this is a secondary driver rather than the primary driver for these initiatives.
Founder & CEO, SOLABS