Thoughts from the team

21 CFR Part 11 Compliance for Electronic Records

Organizations increasingly rely on computer-based technologies for their R&D and manufacturing processes. Data from these technologies is electronically captured, analyzed, and maintained. The FDA provides compliance requirements under 21 CFR Part 11 for electronic data collected by all industries that fall under its jurisdiction. These requirements align will OECD (Organization for Economic Cooperation and Development) initiatives.  The intention of both is to help ensure that the electronic data collected is trustworthy, reliable, and equivalent to paper records.  


March Madness Recap

With snow banks quickly disappearing and giving way to the lawns underneath, spring is finally in the air in New England!  The March weather was quite fierce with three severe snowstorms in a two-week period.


Precipitation, in the form of rain or snow, is associated with atmospheric pressure drops. Meteorologists often use barometric data to predict precipitation.  A large pressure drop in a 24-hour period results in the infamous bomb cyclone phenomenon, which New England experienced during the first week in March.  Subsequent storms were also accompanied by notable atmospheric pressure drops.  


The Element-A solution in our Cambridge, MA office noted the various pressure drops at the times of snowstorms.  The days of the snow storms were:

Snowstorm #1 (the bomb cyclone) – March 1-2, 2018

Snowstorm #2 – March 7, 2018

Snowstorm #3 – March 13, 2018


These dates coincide with the pressure drops recorded by our Element-A device, as shown in the figure below:

These pressure changes are relatively small and almost indistinguishable to humans, but they are important in understanding weather patterns.  Here’s to hoping that the next pressure drops in New England are April showers (not snow) that bring May flowers!

Interphex 2018 NY, NY

Elemental Machines is looking forward to showcasing our next generation lab solutions at Interphex 2018 at the Javits Center in New York, NY on April 15-17, 2018.  

Stop by Booth 4055 to learn more about our solutions for biotech, pharma, and medical device companies.  Our products harness the power of data-driven insights to help customers improve laboratory operations, research, development, and manufacturing outcomes.


Some Samples are Irreplaceable

In a one-week period, two fertility clinics in the US reported issues with cryogenic storage conditions for frozen eggs and embryos. As a result, the viability of thousands of egg and embryo samples is now in question. The estimated cost of lost material, based on the medical procedure expenses and annual storage fees, exceeds ten million dollars.  To further complicate matters, in some circumstances, the lost embryos are irreplaceable, as highlighted in lawsuits against both facilities.


SynBioBeta 2017 | Glimmers of Hope

SynBioBeta is an annual conference — now in its sixth year — that brings together experts and innovators in synthetic biology, ranging from academia to entrepreneurs to industry. In addition to being a great place to cross paths with dear friends from previous chapters of my career and hear from luminaries like George Church, what is always most striking to me is the intellectual horsepower in this industry that is being applied to humanity’s biggest challenges — from sustainably feeding, clothing and accommodating a growing global population to improving human health.


The Good, the Bad and the Ugly | Lab Monitoring Survey Results

People love surveys, and we’re no exception. After all, data from a pool of respondents on an interesting topic lets you pattern match to see if your profile matches your cohort. So, being the curious types that we are, Elemental Machines conducted a survey of lab managers and other science professionals to:

  • Learn more about their experiences and monitoring priorities,
  • Understand how they think about strategic uses of the data, and
  • Know what they do with the data and where they store it.

Here’s what we found.