Starting with your compliance needs, will lead you to your remote monitoring solution requirements
In 1997, the FDA passed 21 CFR Part 11, introducing
requirements for signing and controlling electronic records. The Annex 11
update added a few additional requirements, but neither Part 11 nor Annex 11
altered the overall validation process. Today, however, the industry landscape
is forcing life science companies face new compliance challenges such as:
- · Managing growth through global expansion, mergers and acquisitions
- · The “coming of age” of enterprise-wide systems remote monitoring solutions, cloud computing and the wide distribution of mobility platforms
- · Increased investments in research, manufacturing, marketing and delivery
- · The interpretation of global regulatory requirements, including those of non-FDA, regulations, like SOX, Bill 198 or ISO/IEC 27001, that impact IT departments.
As manufacturers of indicators, data loggers and remote
monitoring solutions, that means new data models are needed that allow for
better regulatory support and data integrity. Why? Because regulations change
rapidly and geographically, so data reporting and analytics must have the
flexibility to change with it. This also means that, with potentially thousands
of data recorders on the market today, there will be a need to remotely
configure and update recorders for those standards. In the end, this provides
better customer support and longevity to products already deployed in the
field.
Can data loggers and remote monitoring solutions be adaptable for tomorrow's regulations?
A data recorder’s (or remote monitoring sensor’s) primary
purpose is to automatically collect data points from sensors and make these
data points available for review, analysis, and decision making processes. More
complex devices can also be programmed for other purposes, such as alarm and
control conditions. Those recorders developed for the
life sciences market, though have an additional concern, long term data
integrity. And, while physical data loggers use microchips that are getting
more and more rugged and reliable, they still require routine maintenance,
calibration and have a risk of failure. Therefore, it is logical to assume that
the way to assure data integrity is to provide a transmission and storage
mechanism that can be automated, backed up and is accessible. The cloud offers
that assurance.
Thus, when choosing between a stand-alone sensor or an
integrated, remote monitoring solution, look to regulations, growth potential,
ability to maintain the sensors and long term data storage requirements.
