What Features Ensure Compliance?

I hear the word ‘compliance’ tossed around all the time but I suspect that many of those using the word only have a very vague idea about what it means. Compliance usually refers to the adherence to the rules that have been imposed upon you by the law or some type of regulatory body. But what technical capabilities are required to actually comply with such legal and regulatory requirements?

First, let’s be clear. You don’t use the word compliance when you are referring to something that you really want to do. Compliance usually means an inconvenience that you are required to do. It rarely saves you time or money. However, compliance is designed to protect you from failure, from disruption, from poor quality, from wrong decisions, from danger, from injury, and - if you live in America you’ve probably guessed it - from lawsuits. Various parties may be interested in protecting you from all of those risks. It could be a consumer safety regulator (i.e. the FDA in the pharma industry), your government (federal, state, or local), or your employer. But how does that actually work?

First, compliance often means to assure that proper authorization is in place for important decision making. That starts with access control - making sure that the right people have access to pertinent information at the right time. That usually involves a dose of security - preventing any unauthorized actor from manipulating the information or the decisions.

The decisions themselves are often required to be documented in a non-repudiable way. This is where electronic signatures come in. Unlike digital signatures which deal with mimicking the paper-based ‘wet signature’ in a digital form, e-signatures are all about capturing who, when, what and why. Electronic signatures are simply a data object with name, date, and brief justification that become attached to a version of a document. When someone changes the document version, the e-signature is invalidated. “I didn’t sign off on this version of the medication packaging” is what e-signatures are all about in the pharma industry’s FDA’s CFR 21 Part 11 regulation.

Other compliance requirements, such as Six Sigma and the various ISO customer service quality standards, ask to ensure that certain mandatory process steps are completed before the process can advance to the next stage. This is where technologies such as workflow  and BPM come in - workflow for processes where all steps occur within a single system and BPM for processes that cross multiple systems.

At the end of any process, many regulations require that all the artifacts are stored as proof in case of a potential audit or lawsuit. That’s the role of archiving and of course also records management. Records management not only stores the required information for a prescribed period of time, it also classifies the records to assign them a retention policy that specifies how long the record is to be kept and what should happen with it when the retention expires. Records management also deals with requirements such as legal holds (pausing of any record shredding during a lawsuit) and secure records disposal to prevent forensic recovery.

Finally, many regulations require the ability to trace back any steps for the purposes of an audit or investigation of an incident. This is where auditing comes in with the ability to record a timestamp for every event in an audit trail and the ability to easily review and analyze the audit trail.

There are many other capabilities that may be part of a compliance solution. The specific regulations drive the requirements. Beyond access control, e-signatures, workflow/BPM, archiving, records management, and auditing, compliance requirements may include search, publishing, secure communication, collaboration, and many other capabilities. Records management has been receiving plenty of attention lately; so much that many equate compliance to records management. Yet there is much more to compliance than records  which is what I wanted to show in this post.

Is It Time for DC Power?

In the 1880s, the War of Currents was raging between the two main factions - direct current (DC) which was heavily promoted by none other than Thomas Edison and alternating current (AC) advocated by George Westinghouse. The DC system was developed first and worked well for lighting which was the primary use of electricity in its early days. The AC system, however, has proven to be more efficient for powering motors and for carrying energy across long distances. In the end, AC won and the rest is a history. Today, our electricity grid is AC based.

Thomas A. Edison

When I look around my house today, I see a number of motor-based appliances including the washer, dryer, refrigerator, heater, air conditioner, etc. Those appliances use AC and that is the more efficient source of power for them. Yet increasingly, more and more of my electrical devices use a power adapter because they run on DC power: computer, printer, iPhone, iPad, PC speakers, cordless phone, Apple TV, TV set, alarm clock, radio, not to mention the many devices that use batteries: camera, keyboard, mouse, flashlight, fire alarm, etc.

Using all the power adapters to generate DC power is a hassle because of the lack of standardization. We practically have a different adapter for each device which is hugely inconvenient. Traveling with a bag full of power supplies is a major pain as I have written about in my post Environment and the Power Charger. In addition, power supplies are only about 70-80% efficient which means that about a quarter of the energy we produce (and pay for) is wasted on the AC to DC conversion.

This situation is particularly absurd for the increasing number of households that use solar panels to augment their power supply, often making them entirely independent from the AC power grid. The power produced by the solar panels is DC power. All the solar systems today require expensive inverters to invert the DC current into AC current. These inverters are expensive, often representing a significant portion of the entire cost for the solar power system. They are also inefficient, with efficiencies ranging from 50-90% - this is where we lose up to 50% of the energy produced by the solar panels!

So we are inverting DC solar power into AC current to power the house while losing up to 50% of the energy. At the same time, our devices increasingly use the DC power which requires an adapter that loses another 25% of the energy. So we are losing a significant percentage of the energy that we pay for. That sounds pretty inefficient, doesn’t it?

LED light bulbs may be the trigger

The story becomes even more interesting with the advent of LED-based light-bulbs. Lighting represents about 20% of household’s energy consumption today and switching to the LED light bulbs offers great opportunity to save on the monthly energy bill while doing something good for the environment at the same time. The LED lights are still pricey but those prices will surely go down, just like they did for the fluorescent light bulbs a decade ago. The problem with the LED light bulbs is LEDs work on DC and so each LED bulb has to contain a power converter which converts the house AC into the DC that the LED lights need. More AC/DC craziness, not to offend any rock fans...

All of this begs the question - is it time to wire our houses for DC power? We have standardized DC power in our cars with a slew of gadgets and appliances using the "cigarette lighter outlets" - from phone chargers and GPS to air pumps and mini-refrigerators. Many airlines provide a DC outlet in every seat to power our laptops and other gadgets. Why not have such DC outlets in every room of the house? Why not have the lights wired on a DC circuit?

USB outlets exist today

Sure, we will still need to transport power across long distances and we’ll need an AC circuit to power the big appliances with motors. But most houses have a separate 220V circuit for big appliances in addition to the standardized 110V wiring. In Europe, most house have 220V (well, 240V really) and they also have a 380V circuit for their washer, dryer, water heater and other big appliances. Why not have a separate DC circuit for all the devices? AC would come to the house like it does today but one single converter would replace all of those individual power adapters. On top of that, DC power is easier to store and a couple of batteries could provide an effective backup power supply.

Re-standardizing something as essential as the power system is a major undertaking. But we live in the times of major undertakings. If Google can take pictures of every street in the world and Tesla can build a network of charging stations throughout the entire country and SpaceX can fly to space, we might be also capable of switching to a more efficient power circuitry. We even have a standard - USB - which may not be meeting all the needs, but could be a starting point. Of course, we would first have to convince Apple to add USB interface to all their devices...

PS: Thank you, Brett, for an inspiring dinner conversation!