“Of course it wouldn't [specify], because that's an area of federal law
where we'd want to have as much ambiguity as possible.”
~ The West Wing
If you’d mistaken the preceding line of fiction for the chatter of a laboratory compliance specialist, you’d be forgiven. Regulatory compliance is one of science’s great necessary evils. Yet without it, research methods and practices would be inconsistent; their results, less reliable.
And yet the powers that be leave much about compliance to the researcher’s imagination. For example, ISO 9001:2015 orders that an organization “maintain a quality management system,” while the FDA requires a “risk-based approach.” As for how, both leave much up to the interpretation – and implementation – of the reader.
In the US, much of the FDA’s regulations come from Title 21 of the Code of Federal Regulations (CFR). Today, the CFR has over 100 million words and would take over 3 years to read!
It’s no surprise that over the years, we’ve received numerous enquiries from clients who are just setting up their operations, asking how to design Quality Systems that are compliant with cryptic regulatory guidelines.
The ambiguous mandates are costly ones. The total cost of compliance spans budgetary categories and org charts, tacking on costs to everything from staffing and development to scientific instrumentation and even printer toner.
Pharmaceutical companies devote an average of $18.2 million to compliance each year, while the industrial sector averages $29.4 million.1 Perhaps the only thing more costly than compliance is non-compliance, which can result in criminal charges, forfeitures, and civil claims.2
Much of the energy devoted to compliance comes down to monitoring and surveillance. Satisfying the FDA’s risk-based requirement is a matter of somehow setting a risk score, then monitoring to determine if your wild guess initial estimates had any basis in reality.
Herein lies the considerable advantage of intelligent monitoring. Our Elements A, C, D, and T replace yesterday’s archaic paper records with always-on, never-distracting sensors that turn a lab’s existing equipment into internet-connected devices in 60 seconds.
No, sensor technology is nothing new. But the user interfaces utilized by the sensors, and the insights they offer, represent a stark dividing line among today’s alerts and monitoring technologies.
As one of our current customers learned the hard way, much of the market’s existing technology gives little thought to compliance. Their previous monitoring platform offered a single, clunky output: CSVs. As if the cumbersome downloads weren’t bothersome enough, the format failed to meet the standards outlined in FDA 21 CFR Part 11. As the customer told us, "We felt like we had to babysit the program instead of it working to help us."
The Elemental Machines Insights platform ensures the authenticity, integrity, and confidentiality of electronic records, satisfying a wide range of GxP requirements, including:
- Electronic Record Authenticity (21 CFR Part 11)
- Electronic Record Integrity & Confidentiality (21 CFR Part 11B)
- Alerts & Monitoring (21 CFR Part 1271 )
- System for User-Generated Records (21 CFR Part 1271)
- Customer Data Protection (GDPR)
- Lab Equipment Protocols (21 CFR Part 58D)
For more information regarding GxP compliance, download our comprehensive guide here.
Of course, there’s much more to monitoring that compliance alone. Such comprehensive observation can also have unexpected benefits. When a customer monitoring a bank of incubators using Element Ds noticed that hidden humidity settings had inadvertently reset after a service call, he corrected the settings before the error spread. Another customer now uses Elemental Insights even more proactively, consulting reliability data before making purchasing decisions.
The mandates set forth by our regulatory bodies may be ambiguous at times (and they’re certainly costly to implement), but this same ambiguity is what actually gives companies the latitude to create systems that suit their specific needs. When an entire industry has flexibility to craft their own types of compliance guidelines, any supporting technology must be equally (if not more) adaptable.
The advances brought forth by the Elemental Machines platform make adhering to them easier than ever before. Better yet, strategic implementation of such a system can deliver much more value than any red tape might consume.
1Globalscape: “The True Cost of Compliance With Data Protection Regulations”