Want to Have a More Appealing FDA CFR 21 Part 11? Read This!

The most important ones among these are Computer System Validation, data security, and data backup.

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Title 21 CFR Part 11 is one of the sections of the FDA that inspires both awe and respect. Commonly known as 21 CFR Part 11, this section deals with and establishes the criteria for the FDA’s requirements relating to electronic records and electronic signatures (ER/ES). All the requirements which the FDA expects for electronic records and electronic signatures to be considered trustworthy, reliable and equivalent to paper records are set out in this section.

For the FDA to consider electronic records, electronic signatures and handwritten signatures to be on par with handwritten ones and proven for their safety, trustworthiness and authenticity; companies in the designated industries governed by FDA regulations have to meet conditions set out in 21 CFR Part 11. It is only when these conditions are met that the FDA considers these records to have the same effect or worthiness of an actual paper record.

As paper made way for electronic versions with the advent of technology; FDA 21 CFR Part 11 regulations evolved with the intention of helping to overcome some of the obvious drawbacks of paper records:

  • Their potential to be manipulated or forged
  • Their destructibility
  • Lack of authenticity.

FDA 21 CFR Part 11 regulations came into being to give electronic signatures the same effect as those of paper ones. These regulations seek to make the electronic signatures as authentic as the paper records they replace through a set of well-defined scientific means. FDA 21 CFR Part 11 is designed to give regulatory authorities the confidence and scientific validation for this authenticity.

The core areas of 21 CFR Part 11 implementation

21 CFR Part 11 regulations compliance covers three core areas:

Standard Operating Procedures

There are nearly 12 Standard Operating Procedures prescribed in the 21 CFR Part 11 regulations for addressing the company’s IT infrastructure. The most important ones among these are Computer System Validation, data security, and data backup.

System features

21 CFR Part 11 regulations require close to 50 industry-related features that organizations need to implement into their computer systems to be compliant with the regulations.

Computer System Validation

The core of 21 CFR Part 11 regulations is Computer System Validation. The purpose of implementing CSV is to ensure that the FDA has documented evidence that each computer system in the organization carries out exactly what it is expected to and helps users detect and identify errors.

How to make your 21 CFR Part 11 effective

Since implementation of 21 CFR Part 11 is mandatory in the industries for which it is stipulated; it is necessary to those who work in these industries to get a proper and thorough idea of how to properly implement the provisions of this regulation.

Adapt a risk-based approach. This is the foundation to 21 CFR Part 11 implementation 

The basis to effective implementation of 21 CFR Part 11 is to take a risk-based approach to implementation. A risk-based approach should take all the possibilities of risk into the area of electronic signatures and work on ways of countering them. Understanding the risks is the foundation to implementing 21 CFR Part 11 effectively, as it helps to identify areas from which risk could arise to the electronic signatures.

The risk-based approach is not only a very solid means to ensuring the effectiveness of 21 CFR Part 11 regulations; it also prevents the organization from being cited by the FDA, since this is the method the FDA itself suggests and welcomes. It is also extremely useful in making the organization’s computer systems more effective and inexpensive over time.

Train your staff

The key to effective and proper 21 CFR Part 11 implementation is for the organization to let its employees know the importance of this regulation. It is only when employees, as stakeholders in the organization’s growth, are enlightened about the importance of critical regulations such as 21 CFR Part 11 that they understand why they need to implement, what benefit they get out of implementing it, and what they stand to accrue in terms of penalties for lack of implementation that they take a keen interest in its implementation.

Again, training too, is a core FDA requirement. The FDA has laid out clear-cut guidelines of how to train employees for 21 CFR Part 11 implementation and the ways of documenting the training. Organizations that comply with these requirements are less likely to invite FDA actions.

The most incredible technology you’ve never seen

The biological world has already demonstrated what’s possible on this scale — if we’re going to aim big as a species, it’s time we think small.

There’s money to be made and lives to be saved with the tiny stuff that’s all around us.

Saving the world (or some subset of people in it) is in vogue among the world’s wealthiest.

Jeff Bezos has a rocket company, Blue Origin. Bezos believes our future is extraterrestrial, and his rocket company exists because he thinks the price for getting anything off this rock is too damn high.

Bezos is not alone. Elon Musk is also building huge, reusable rockets. He wants to see humans fly to Mars, initially on a lark but eventually for forever.

This type of long-term thinking about the future of our species coupled with serious investment is important. But Bezos and Musk (and most other investors) are missing the most significant — and smallest — technological opportunity to save humanity.

No one has captured this tech blindspot better than my friend and Ginkgo Bioworks Co-Founder Jason Kelly. He did it by showing an image like this:

“What’s the most advanced piece of technology you see on this desk?,” Kelly asked his audience. The correct answer is in green.

A $4 houseplant is one of the most astonishing objects ever assembled. It’s a biodegradable, carbon-capturing, self-replicating, solar-powered work of art. Have you ever bought an electronic gadget that even comes close?

The mind-bending fact that a common shrub is more advanced than the latest MacBook Pro is overlooked by almost everyone. We fail to see it for a simple reason: the coolest parts of a plant can’t be seen. Not with the naked eye, at least.

It’s at the molecular level that plants fix CO2, soak up sunlight and churn out nutrients that we can eat. Way down at the level of atoms and molecules, the most mundane living objects are doing things that our best engineers can only dream of.

Small solutions to big problems

Humanity faces enormous, imminent challenges. The way we use energy is poisoning the planet, we are on track to use up many of our most important non-renewable resources, and we are ill prepared for the next inevitable global pandemic. And that’s just a small sampling of the challenges we see coming; there are dozens more around corners we can’t see around.

Major advances in deep tech — the marriage of hard sciences and emerging technology — is going to be critical if humanity is to survive these challenges and thrive, but most of the money in the world is maintained or managed by people who do not have formal scientific training. For example, just 5% of the Forbes richest 400 people have formal scientific training. Most therefore invest in things they’re familiar with, like real estate, software and finance.

I founded OS Fund to support the scientists entrepreneurs bringing deep tech to market; leveraging hard sciences and technology to rewrite the basic operating systems of our world. Atoms, molecules, genes and proteins can be designed like never before. The biological world has already demonstrated what’s possible on this scale — if we’re going to aim big as a species, it’s time we think small.

At OS Fund, we don’t invest in particular problems. Instead of trying to solve energy or climate change or the spread of disease, we invest in the foundational technology that could be applied to solve all problems. In the same way that early computer companies like Intel, Apple and Microsoft helped spawn the modern era of computing, we aim to do the same thing with atoms, molecules, organisms and complex systems.

The scientists at Ginkgo Bioworks, one of the first companies in the OS Fund ecosystem, are charting their way by designing bacteria that puff out perfume, crops that fertilize themselves, gut microbes to make medicine, and much more. With three highly automated foundries up and running, the company is poised to upset almost every industry you can think of.

Arzeda, another OS Fund company, is using computers to design new genetically-encoded nanomachines, otherwise known as proteins. Although most of us know proteins only as food, these intricate biological objects actually do almost all the work needed to keep cells alive. Designing new proteins from scratch will let humanity play by biology’s rules, meaning we can design our way to better food, fuels and chemicals in the greenest way possible.

Another OS Fund company rewriting our world is NuMat, where they’re arranging atoms in MOFs (metal organic frameworks) to create the most powerful sponges you’ve never heard of. NuMat works at the intersection of high-performance computing, chemistry, and hardware systems to design and manufacture materials that can filter non-renewable material like xenon out of thin air.

But wait, I can hear you thinking, isn’t AI going to eliminate the need for this kind of innovation?

View story at Medium.com

View story at Medium.com

You Will Never Believe These Bizarre Truth Behind Food And Beverages

Further, out of these, nearly 20 million, one in 16 Americans, visit a full-service restaurant on any given day.

The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no place on this planet that this industry does not cover. You are as likely to find a food joint in Mongolia as you are in Mozambique. The reason is simple: we can live without many things, but not without food. Any surprise that this industry is a giant, valued at a few trillion dollars globally?

The food and beverages industry in the US is characterized by several interesting facts. Many of these could be in the positive and some, in the negative. Whether it is about the positive or the negative factors one is talking about, there is no doubt about one thing, which is that the food and beverages industry is one filled with very interesting facts. Let us take a look at some of these:

One in seven Americans eats fast food everyday

It is estimated that as many as 50 million Americans consume fast food every single day, without a weekend or a vacation! This is more than the population of many countries. The most important reason for this is the quickness and convenience associated with fast food. Further, out of these, nearly 20 million, one in 16 Americans, visit a full-service restaurant on any given day. Yet, surprisingly, this is the same percentage of Americans who have been eating outside for the past 15 years!

Millions of children eat fast food in the US

As many as a third of the children aged between two and nine years eat fast food daily in the US. The media could be playing a part in this because it is estimated that on average, the American child is exposed to three to five ads for fast foods every single day. This rate of consumption is cause for some worry for policy makers and health experts, although one silver lining could be that children are more aware of the importance of eating clean food.

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American cuisine is still the top hit

Among the millions of Americans who make up the market for the food and beverage industry, four fifths of all food consumed in hotels in the US is American. While the cuisines of most other countries are still popular, this figure points to the overwhelming preference for American food by those who eat outside. Want to know which the least preferred cuisine is? It is Scandinavian and Nordic food, which is consumed by only two percent of those eating outside. Adding to the interesting facts about the food and beverages industry is the point that a high proportion of Americans like their food to contain local, fresh ingredients and flavors.

Americans eat the most outside during warm weather

Call it a case of sunny binge or the lethargy of getting out of home during the cold seasons; it is a fact that Americans eat more outside during the warm seasons.

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The fast food industry is highly concentrated

While there are hundreds of players in the fast food industry, an interesting fact about the food and beverages industry is that almost all the food consumed by the Americans is sold by only a handful of companies such as PepsiCo, Kellogg and General Mills and a handful others.

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Information about the food is an important factor

Another of the interesting facts about the food and beverages industry is that for Americans who eat outside, information about the food’s nutritional content is a major factor when it comes to eating outside. This is followed by how many options the restaurant offers for low calorie foods.

Want to recommend a restaurant to a friend? Think again!

Surprising as it may sound, one of the truly interesting facts about the food and beverages industry is that a friend’s recommendation or online suggestions are the least important factors that motivate people to go out and dine at restaurants. The top factors are still the quality of food, followed by the time taken to travel to the restaurant and the quality of service.

Move towards cleaner food

The move towards cleaner food by the industry as a whole is one of the other interesting facts about the food and beverages industry. With children themselves becoming aware of the need for cleaner food, as we just saw, does it surprise that chains such as McDonalds are making conscious efforts towards preparing and selling cleaner food?

Cleaner food

Nutritional labels can be deceptive

Facts about nutrition that are ubiquitous on food labels are misleading. They are almost never 100% truthful. While the facts relating to the percentage of the ingredients may not be fully wrong, the claimed benefits can be off target. Isn’t is one of the interesting facts about the food and beverages industry that in this information-driven society, there is still a lot of scope for manipulation?

Now, the most unpleasant interesting fact about the food and beverage industry…

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America leads in food waste

Whether it is at homes or in restaurants, especially in the latter, the proportion of food that is wasted is extremely high. As much as two fifths of all the food eaten in restaurants ends up in the waste baskets. One of the main reasons for this factor is that what is left behind in the plates is insufficient to make a full meal of, as a result of which it finds its way to the bin. When the food wasted in transport and while being cooked is accounted for, this amounts to an average of $2,000 being spent on just wasting food by every American during a year.

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This gives North America the dubious distinction of being the top waster of food anywhere in the world. This region wastes around 95-110 kilos of food per person per year, which places it several notches ahead of the region at the other end of the list: sub-Saharan Africa, which wastes around six to seven percent of this ratio. This wasted food can have extremely serious consequences for the rest of the world. While being responsible for a carbon footprint of about three gigatons, this wasted food also consumes as much as 28% of the world’s agricultural area!

https://www.weforum.org/agenda/2015/08/which-countries-waste-the-most-food/

http://www.fao.org/docrep/018/i3347e/i3347e.pdf

https://www.theatlantic.com/health/archive/2012/08/how-40-of-our-food-goes-to-waste/261498/

http://www.urbancultivator.net/facts/

https://www.livestrong.com/slideshow/1011186-9-hidden-food-industry-doesnt-want/

https://pos.toasttab.com/blog/10-fast-food-industry-statistics

https://www.statista.com/topics/1957/eating-out-behavior-in-the-us/

No one can believe this update [MIT vision system]

It generates a “visual roadmap” — basically, collections of visual data points arranged as coordinates.

Robotic vision is already pretty good, assuming that it’s being used within the narrow bounds of the application for which it’s been designed. That’s fine for machines that perform a specific movement over and over, such as picking an object off of an assembly line and placing it into a bin. However for robots to become useful enough to not just pack boxes in warehouses but actually help out around our own homes, they’ll have to stop being so myopic. And that’s where the MIT’s “DON” system comes in.

The DON or “Dense Object Nets” is a novel form of machine vision developed at the MIT Computer Science and Artificial Intelligence Laboratory (CSAIL). It generates a “visual roadmap” — basically, collections of visual data points arranged as coordinates. The system will also stitch each of these individual coordinate sets together into a larger coordinate set, the same way your phone can mesh numerous photos together into a single panoramic image. This enables the system to better and more intuitively understand the object’s shape and how it works in the context of the environment around it.

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“At its coarsest, highest level, what you’d get from your computer vision system is object detection,” PhD student Lucas Manuelli, author of the paper, told Engadget. “The next finest level would be to do pixel labeling. So that would say, okay, all these pixels are a part of a person or part of the road or the sidewalk. Those first two levels are pretty much a lot of what self-driving car systems would use.”

“But if you’re actually trying to interact with an object in a particular way like grab a shoe in a particular way or grab a mug,” he continued, “then just having a bounding box or just all these pixels correspond to the mug, isn’t enough. Our system is really about getting into the finer level of details within the object… that kind of information is necessary for doing more advanced manipulation tasks.”

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That is, the DON system will allow a robot to look at a cup of coffee, properly orient itself to the handle, and realize that the bottom of the mug needs to remain pointing down when the robot picks up the cup to avoid spilling its contents. What’s more, the system will allow a robot to pick a specific object out of a pile of similar objects.

“Many approaches to manipulation can’t identify specific parts of an object across the many orientations that object may encounter,” Manuelli, wrote in the study. “For example, existing algorithms would be unable to grasp a mug by its handle, especially if the mug could be in multiple orientations, like upright, or on its side.”

The system relies on an RGB-D sensor which has a combination RGB-depth camera. Best of all, the system trains itself. There’s no need to feed the AI hundreds upon thousands of images of an object to the DON in order to teach it. If you want the system to recognize a brown boot, you simply put the robot in a room with a brown boot for a little while. The system will automatically circle the boot, taking reference photos which it uses to generate the coordinate points, then trains itself based on what it’s seen. The entire process takes less than an hour.

Really awesome you also don’t believe this via https://engt.co/2wWDPCj

Medical Wearable Devices Health Technology [Fads or the Future]

The fitness wearable company has adopted Google Cloud for Healthcare application programming interfaces (APIs) in a bid to make data sharing more secure.

The wearable health technology craze looks like it’s here to stay but some devices are proving more useful to the medical industry than others. Which of the most talked about devices are fads and which could be the future?

As the wearable health technology market continues to grow it can be hard to distinguish the trendy consumer devices from those with useful medical applications. From the debate over smart watches to the latest wearable MRI scanner, here’s a roundup of some of the most talked about wearables. Many of them are pointing the way to the future of patient care.

wear electronics

In the ever growing wearable health technology market, Fitbit is arguably the most well-known brand. Extremely popular with consumers, fitness tracking Fitbit watches are not a favourite among medical professionals due to claims that the patient data collected is not accurate enough for medical assertions to be made. However, Fitbit remains determined to break into the healthcare market and partnered with Google earlier this year to improve the ability of its devices to share data with medical professionals. The fitness wearable company has adopted Google Cloud for Healthcare application programming interfaces (APIs) in a bid to make data sharing more secure.

The more medically trusted smart watches include the FDA-approved Empatica smartwatch, called Embrace, which is designed to monitor seizures. The AI-powered device uses advanced machine learning to check for grand mal or generalised tonic-clonic seizures and can send instant alerts to caregivers.

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Continuous glucose monitors (CGMs) are becoming increasingly popular with diabetic patients, who can wear the devices day and night to keep an eye on their glucose levels. The popularity of the devices lies in the fact that a patient can view their glucose levels with a quick glance and only have to use a finger prick blood test twice a day to check that the readings on both devices are similar.

Real-time glucose levels help patients make more informed choices about the types of food, physical activities and medication they require throughout the day. CGMs work by using a tiny sensor inserted under a patient’s skin which tests interstitial glucose levels every few minutes and sends this information to a monitor or smartphone. Patients receive alerts when their glucose levels need to be adjusted.

Devices like the Dexcom G6 are popular because they claim to negate the need for patients to use finger sticks.

Diagnostic wearables

No matter how advanced healthcare is becoming there is always an occasion when healthcare professionals just aren’t sure what is wrong with a patient. This is where diagnostic wearables come in.  Australian National University (ANU) researchers recently developed optical sensors that can be used in wearable medical devices to diagnose various diseases in real-time. The sensors measure very small concentrations of metabolite gases, which are emitted through human skin and breath, and use these measurements to detect biomarkers which can indicate a variety of diseases.

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Other new diagnostic wearables include body-worn sensors that can assess gait and potentially detect Alzheimer’s disease early. Diagnostic technologies like this definitely have a future as the healthcare industry continues to look for ways of diagnosing chronic conditions earlier.

Cardiac monitors

Wearable imaging

More interesting topic if you miss you never understand http://bit.ly/2MTQpvQ

Most AI Applications that have real-world business significance for debt collection [today]

Today seem to be in personalizing communications to customers and identifying clusters of similar debtor profiles.

According to the Consumer Financial Protection Bureau, Americans filed more grievances about debt collections than about any other financial incident. Of the 316,810 complaints received by the CFPB about debt collection in 2017, the most common was, “Continued attempts to collect debt not owed,” which was cited by 39 percent of grievance filers.

Debt collection in finance is starting to be disrupted by artificial intelligence due to the availability of massive amounts of historical records of customers for banks and other financial institutions. Most AI applications that have real-world business significance for debt collection today seem to be in personalizing communications to customers and identifying clusters of similar debtor profiles.

From our research we have segmented the AI applications for debt collection into the following broad segments:

  • Driving Additional Messaging Campaigns
  • Customer Service (Debtor) Personalization
  • Debt Management Service

We delve further into each of these applications and aim to coax out the need-to-know factors for business leaders regarding AI usage for debt collection.

Driving Additional Messaging Campaigns

Tailoring interactions to debtor habits could be possible with AI today. Virtual assistants are starting to be deployed through channels in which collections agencies can reach out to debtors through email SMS, and outbound dialing, allowing organizations to increase the number of individuals that they’re able to contact on a daily basis.

TrueAccord

TrueAccord was founded in 2013 in San Francisco and claims to be offering an AI-driven debt collection solution. The 97-employee company claims to be offering debt collection solutions to banks, eCommerce and telecom companies.

TrueAccord claims that their decision engine uses machine learning to create digital interaction experiences that are customized for each debtor. The company claims its platform can create an interaction model for each debtor.

TrueAccord claims this model provides banks with the best possible channel and time to reach out to existing and new debtors which might eventually result in better debt revenue collections.

The company says more than 1.5 million debtors have already been modeled using their platform. Based on these existing debtor profiles, their software claims to predict an individual’s response time, schedule, best communication channel, and type of content that they’ll respond to.

TrueAccord adds that its decision engine can automatically select the appropriate pre-approved messages from banks to deliver to debtors. The software also tracks, in real time, the action events from the debtor, such as interaction with call centers, or email opens, link clicks and browsing patterns on TrueAccord assets. The software then sends this data to employees at debt collecting agencies so they can plan the ideal style and time of their next message.

What channel the next message should likely https://goo.gl/gGHvYg

CAPP Presents Roadmap for Telehealth Adoption to Improve [Patient Care]

How can telehealth realize its potential to improve patient care? The Council of Accountable Physician Practices (CAPP), a coalition of visionary multi-specialty medical groups and health systems, answers this question in its new primer.

“Telehealth tools have the potential to transform healthcare delivery by improving access, quality, and efficiency,” noted CAPP Chairman Stephen Parodi, M.D., associate executive director, The Permanente Medical Group. “However, there are significant barriers in realizing these benefits due to current cultural, regulatory, and payment practices. At this pivotal time, we must Telehealth into daily clinical practice http://bit.ly/2oeHTZO services are deployed in appropriate ways that are embraced by physicians and patients alike.”

To help guide that transition, CAPP physician leaders identified six critical principles for stakeholders to consider.

1. Telehealth must integrate, not fragment, care.

Telehealth tools are most effective when they are used in the context of an already-established relationship between a patient and an accountable healthcare delivery system. In that setting, telehealth encounters with a patient’s own provider or system are simply another means of delivering integrated, comprehensive care, and supporting the capability to provide value-based care.

2. Telehealth improves quality, access, and convenience; cost-savings are not the primary benefit.

Short-term savings for payers should not be most important feature of telehealth. In the experience of most CAPP groups, telehealth visits via phone or video did not replace in-person care, but rather augmented it. Potential cost savings will be realized in the long term as telehealth tools expand access to preventive care and disease management, eliminating the need for more costly interventions in the future.

Telehealth into daily clinical practice http://bit.ly/2oeHTZO