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.


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.

Facts that Everyone Should Know About Fda Regulation

Many cultures outside the US use these for recreational purpose with the approval of society and governments, with there being nothing illegal about them.

The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these areas.

For the average American consumer, the FDA is a protective agency that ensures that the foods and medicines consumed by Americans is of world class standards of quality and hygiene. It is also perceived as the agency that stalls bioterrorism by ensuring strict vigilance over this nefarious activity. All these make the FDA a source of comfort for many consumers in the US. After all, when Europe was shaken by the thalidomide scandal of the 1960’s, the FDA, under the stewardship of Frances Oldham Kelsey, showed exemplary alertness and diligence by not allowing it to be sold in the US because it failed to convince this woman of the extent of its standards into this product. The result: prevention of birth defects in potentially thousands or even hundreds of thousands of children, a malady that affected an entire generation in Europe.

To the manufacturers of the products that the FDA regulates, however, it is a stringent regulatory body that is highly adamantine in its approach and is unsparing of anyone. It is often seen as an arm chair critic who doesn’t have to get to the thick of action and just sits on a high pedestal, dictating terms without allowing for the slightest latitude in its strict regulatory requirements.

What is the truth about the FDA? Well, somewhere between.  Let us get down to understanding a few facts about the FDA which will help us understand why it is so stern in setting out standards for regulations and implementing them.

It only does its duty as a health watchdog

The FDA’s primary goal is to ensure public health and to foster innovation and cost-effectiveness in the production of health products. It leaves no stone unturned in its quest to ensure this. This is why, many times, it gets down to hairsplitting details about the processes or composition of many products. It is also not easily convinced about the processes and methods adapted by companies, which is why it has its set of standards that are common to everyone in the respective industry.


Only companies that strictly adhere to the requirements can expect to have their products approved for marketing. When companies fail to meet the requirements of the FDA, they have to carry out a series of often painful and tedious corrective measures. If organizations fail to do this to the FDA’s satisfaction, they can face strict consequences. Many organizations have been penalized to an extent where it has impacted the business. Companies having to shut down their business also has not been unheard of.

Other facts everyone should know about FDA regulation

If all these are an overview of the functioning of the FDA, then, there are many other facts everyone should know about FDA regulation. Let us start with a bit of history to understand how regulation is inbuilt into the FDA:

Although created in 1906, it gained more legislative teeth with the passage of the Federal Food, Drug and Cosmetic Act of 1938. This legislation came into being after a tonic, although legally marketed, killed over a hundred people, including many children. This was when the FDA’s system underwent an overhaul with added emphasis on regulation.

Among the other facts everyone should know about FDA regulation, there is the financial aspect of the FDA: With a budgetary allocation of well over $ five billion a year, the FDA has oversight of the consumption by the general American public of medical products, food and tobacco, whose value runs to over $2.5 trillion.

Some of the other facts everyone should know about FDA regulation

Now, some of the other facts everyone should know about FDA regulation:

  • With the exception of some items such as meat, poultry and a few egg products, the FDA directly regulates nearly three fourths of the U.S. food supply
  • The FDA approves close to 20,000 different varieties of prescription drug products for The number is over a third of that, more than 6,000, for medical device product categories. When it comes to animal drug products, the FDA has a hand in the approval of around 1600 varieties. With relation to biological products, the number is around 340
  • Products whose worth adds to about a fifth of all the money Americans spend are regulated by the FDA
  • Although the FDA oversees more than a humungous number of tobacco products-85,000; e-liquids are not included in this list
  • The FDA attaches extreme importance to labeling of medical and other products it regulates. The labeling requirements are very strict and companies that make false claims are hauled up seriously and heavy penalties are slapped on them. Yet, it is estimated that there is a margin of error of as much as 20 percent when it comes to nutritional facts provided on labels.

The FDA and the touchy area of food supplements

The FDA does not regulate food supplements. This is among the facts everyone should know about FDA regulation. It is because of the subjective nature of many food supplements. Many supplements sold in the US and consumed by Americans as food supplements could be put to different uses in the country of their origin. Mood altering drugs are a prime example. Many cultures outside the US use these for recreational purpose with the approval of society and governments, with there being nothing illegal about them.

However, the FDA’s stringent approval process could prevent some products from being labelled purely as drugs because of the effect on the human mind or body and because of the process employed in their production. The FDA has no say in the way these products are prepared, which is another reason for which the FDA may not regulate food products.

The matter with food supplements is that consumers can use them at their own risk. The FDA does not take responsibility for the safety of these products and leave it to the consumer. It is left to the individual consumer. If she has a high comfort level in using these, it is left to the user.






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.


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.


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.


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…


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.


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!








Fast-track review for new (e-cigs) with tech to prevent youth use-[FDA chief]

Agency’s requirement that any new e-cigarettes must undergo review before entering the market prevents them from introducing new products.

The Food and Drug Administration is considering fast-tracking the review process for e-cigarettes that include features that make the products less likely to be used by kids, Commissioner Scott Gottlieb told CNBC on Thursday.

Gottlieb last week announced a historic crackdown on e-cigarettes after reviewing unpublished federal data he’s reviewed showing teen use has reached “epidemic” levels. The FDA ordered five brands — Juul, British American Tobacco‘s Vuse, Altria’s MarkTen, Imperial Brands‘ Blu E-cigs and Japan Tobacco’s Logic — to submit plans within 60 days detailing how they will prevent teens from using their products.

Some manufacturers have said the agency’s requirement that any new e-cigarettes must undergo review before entering the market prevents them from introducing new products that could curb youth use, including bluetooth features that could disable them near schools.

Yet Gottlieb said while companies have talked about these ideas with reporters and politicians, they haven’t raised them with the FDA. He said the door is “very open to that kind of discussion.”

“I think if someone came to us with a good idea about how a product could be modified to be less appealing to kids or less prone to misuse by children, we’d be very interested in that product, and we’d be very interested in having a discussion around that and how we could put that through an efficient regulatory process,” he said.

Juul, the brand that dominates nearly 73 percent of the e-cigarette market, said it “believes technology is absolutely part of the solution.” The company plans to launch bluetooth-enabled devices internationally next year, according to a person familiar with the matter.

Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022. He said Thursday that the FDA is actively considering reinstating the original deadline, meaning companies may soon be required to submit applications. It may also pull flavored e-cigarette products from the market until those applications are reviewed and cleared.

Critics have scolded Gottlieb for ever giving e-cigarette companies more time. He said it was necessary because it wasn’t clear what the FDA wanted from manufacturers. Now, a year later, the FDA has issued some guidelines and plans to soon release more.

If he had kept the original date, companies would have started sending in applications and wouldn’t have received a decision until next year.

“What we couldn’t anticipate, and what we didn’t anticipate, in all fairness, was how fast the youth use would accelerate,” Gottlieb said.

Finally What Fda cheif says https://goo.gl/5tzDCG

Dangers of Liquid Nitrogen in Food, Drinks (FDA Warns)

Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma.

Consuming or handling food and drink products where liquid nitrogen is added just before consumption can lead to serious injury, according to the U.S. Food and Drug Administration.

These products — which have names such as “Dragon’s Breath,” “Heaven’s Breath” and “nitro puff” — are available in food courts, kiosks, state or local fairs, and other places where food and drinks are sold. Examples of such products include liquid nitrogen-infused colorful cereal or cheese puffs that emit a misty or smoke-like vapor, and alcoholic and non-alcoholic drinks prepared with liquid nitrogen that emit a fog.

Liquid nitrogen isn’t toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release. Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma.


“The main issue is that liquid nitrogen must be fully evaporated from food or beverage before it is served. In liquid form, it can cause burns to the mouth, esophagus, and upper airway, leading to perforation or rupture of the organs — which could be deadly.

How it effecting to you never miss https://goo.gl/1EWdFD

What Makes FDA Guidelines So Addictive That You Never Want to Miss?

When this is the rationale for which the FDA passes its guidelines, the imperative to meet these guidelines becomes clear.

What makes FDA guidelines so addictive that you never want to miss them? Well, FDA guidelines are something like the reminders for your car servicing. What happens when you buy a car? You get reminders from your dealer asking you to service it on time. The reason: your car is meant to be in fine shape when you drive it on the roads in real life conditions. What happens if you miss the service deadline? Nothing, except that you could be responsible for an accident which causes severe consequences.

Now, in this scenario, what if you had an idea of how much damage your car could cause in which type of accident? Would you still want to miss the servicing and checkup date? This is the summary of the principle of what makes FDA guidelines so addictive that you never want to miss out on them! Simple: just like how an inadequately serviced car or any other vehicle can lead to accidents and carry grave consequences for either the driver or the accident victim or both; having products in the market that don’t adhere to FDA guidelines has its costs.

Understand the reasons for which guidelines are issued

It is in everyone’s interest to ensure that products produced by companies in the regulated industries meet FDA guidelines. Their task will become a lot less tedious when they understand the importance of these FDA guidelines. After all, for whose benefit are these guidelines made? Is it for the FDA’s? No. It is for the benefit of the consumers, the organizations marketing these products, and for the general health of the public. When this is the rationale for which the FDA passes its guidelines, the imperative to meet these guidelines becomes clear.

To take the case of the example given here further, there is another very strong reason for which meeting FDA guidelines is addictive to the extent that you never want to miss them: stringent enforcement actions that follow from non-implementation. The FDA has prescribed strict penalties for different kinds of non-implementation of its guidelines. Its enforcement actions are carried out in the following four broad categories:

Warning Letters: The first and mildest of enforcement actions; a Warning Letter notes the violations the company may have committed and advises them on what action has to be taken to correct them.

Seizure: This action is about confiscating an adulterated or misbranded product and ensuring that such products do not enter the market or removing them if they already have.

FDA guidelines so addictive that you would never want to miss them!

Terrifying Reason The UnitedStates Just Approved a Drug For an Eradicated Disease

The report, distributed in June, said that the re-production of known pathogenic infections like smallpox utilizing the procedures of engineered science ought to be of the “most elevated worry” for the US.

The Food and Drug Administration (FDA) reported on July 13 that it had out of the blue affirmed a medication that could treat smallpox on the off chance that it were ever discharged as a weapon in a fear monger assault. The solution is called TPOXX (tecovirimat).

“To address the danger of bioterrorism, Congress has found a way to empower the improvement and endorsement of countermeasures to frustrate pathogens that could be utilized as weapons,” FDA Commissioner Scott Gottlieb said in an announcement.

“The present endorsement gives an imperative turning point in these endeavors. This new treatment bears us an extra alternative should smallpox ever be utilized as a bioweapon.”

The potential release of smallpox as a weapon is an extremely concerning scenario; many experts think that a weaponised form of disease is one of the biggest risks humanity faces.

The world isn’t prepared for that probability, nor is it prepared to react to a pandemic sickness that happens normally. That implies it’s conceivable that some kind of lethal pathogen – likely an infection – could spread far and wide.

As Bill Gates said in a recent talk, world governments are ill prepared for these sorts of scenarios.

“In the case of biological threats, that sense of urgency is lacking,” Gates said. “The world needs to prepare for pandemics in the same serious way it prepares for war.”

The return of smallpox

There are good reasons to be concerned about a potential smallpox release.

In theory, only two labs in the world are authorised to possess the variola virus: the CDC in Atlanta, and the State Research Center of Virology and Biotechnology in Russia.

But more samples of the virus may be out there. In 2014, vials containing smallpox were found in a cold storage room of an FDA lab at the National Institutes of Health’s campus in Bethesda, Maryland.

The possibility of an accidental release from that kind of forgotten sample is remote but real.

More concerning is the fact that researchers think it wouldn’t be difficult for an ill-intentioned actor to create a version of the smallpox virus – even a more dangerous one – in a lab.

Since smallpox has been “destroyed”, the vast majority never again get an immunization, which means most by far of the world would be helpless against a flare-up.

The Department of Defense as of late appointed a provide details regarding guard against organic weapons from the National Academy of Sciences, Engineering, and Medicine.

The report, distributed in June, said that the re-production of known pathogenic infections like smallpox utilizing the procedures of engineered science ought to be of the “most elevated worry” for the US.

“The US government should give careful consideration to this quickly advancing field, similarly as it did to propels in science and material science amid the Cold War period,” Michael Imperiale, an educator of Microbiology and Immunology at the University of Michigan and the seat of the council that composed the report, said in an announcement.

Last year, a Canadian researcher studying synthetic biology demonstrated that it was possible to create pox viruses related to smallpox from scratch using genetic material purchased through the mail.

Doing that cost the researcher US$100,000 and “did not require exceptional biochemical knowledge or skills, significant funds, or significant time,” according to a World Health Organisation report.