40 Percent of Companies’ Non-Compliance
Issues Tied to Insufficient Engineering Change Practices
Effectively managing product and process engineering change is becoming
increasingly important to life sciences companies worldwide, whether the
change is to a product’s packaging,
ingredients or design. Yet, according to a recent study with AMR
Research Inc., more than a third of companies surveyed said they still
have no formal change process in place.
The study, “Best Practices and
Thought Leadership in Life Sciences Engineering Change Management,”
surveyed 120 life sciences companies, including pharmaceutical,
biotechnology and medical device and contract manufacturers around the
world, and asked about how their organizations deal with engineering
changes.
Companies that take an integrated approach to managing change can
innovate more quickly, promote compliance with global regulations and
support a profitable, enterprise-wide response to customer demand.
Nevertheless, the study found:
-
only 55 percent of inline life sciences product enhancements launched
in 2007 were rated a success;
-
a staggering 40 percent of regulatory issues, including warning
letters, regulatory inspection observations or compliance observations
were attributed to engineering changes;
-
significant gaps exist in performance, financial planning, regulatory
assessment and documentation management processes between the life
sciences companies and their third-party manufacturers.
The study suggests that life sciences companies are shifting to an
enterprise-wide approach to managing product and process engineering
change to cope with the increasing rates of change in today’s
business environment. By 2011, 46 percent of the companies surveyed
expect to manage change globally, but manage the execution processes
centrally.
The study also shows that even though life sciences companies recognize
the value in planning and are prepared to spend more to better manage
product manufacturing change over the coming years –
38 percent growth by 2011 – significant
barriers to success remain.
