To establish a procedure for the proper assessment of product and process design, Also, to align evaluation of product quality standards for chemistry manufacturing and controls (CMC) review and to maintain quality standards per Office of Pharmaceutical Science (OPS)
It should be noted that OPS is responsible for assuring that the quality of drug products for the entire pharmaceutical industry follow uniform policy and review processes during drug product development (the manufacture and formulation).
Therefore, it is incumbent on all personnel involved with the preparation of documentation for subsequent submission to the regulatory authority recognize the importance of creating and maintaining a clear scientific and sound approach for all products.
Quality target product profile (QTPP) forms the basis for design and the development of the product. Considerations for the Quality Target Product Profile (ICH guideline Q8 R2)
Critical quality attributes (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality
Process Analytical Technology (PAT) which is a Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
Risk Assessment (RA)one can recognizing critical attributes that are going to affect final quality of product
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
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.
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.
We visited Mirror’s HQ in NYC to test it out and to see if it’s really worth cancelling that gym membership for.
Life gets busy. With long days at the office, taking care of a family, making time for friends, and more competing for time on our schedules, it’s tempting to trade in a gym session for some quality time on the couch whenever you get the chance. But with Mirror, the gym is right at home: Part mirror, part LCD screen, it has on-demand workouts built into it.
You’re probably thinking that there’s plenty of at-home fitness equipment on the market, but this one isn’t an eyesore. Unlike a spin bike or treadmill, it also brings you a huge variety of exercises from yoga to barre, and even weight training. But at $1,500, Mirror is an investment you want to be sure about. We visited Mirror’s HQ in NYC to test it out and to see if it’s really worth cancelling that gym membership for.
Looks sleek and high-end
For $1,500, one would hope the product not only works well but looks nice too — especially if it’s hanging in the middle of your home. It does. When we saw the product ahead of its debut in September, we were blown away. At first glance it appears to be a normal mirror with an extremely sleek look framed in dark, carbon steel, but there’s a mineral bronze powder-coated LCD inside.
At the top is a 5-megapixel front-facing camera (which will be used for personal training classes in 2019) that comes with a convenient cover you can slide on and off, for those worried about privacy. It’s a little bulky and distracting, and takes away from the streamlined look of it. The 40-inch display boasts a 1080p resolution, and in our demo, content looked crisp and bright on the screen. To hear your workouts loud and clear, there are also two 10-watt speakers built in.
There’s no touchscreen capability, which might be for the best if you imagine the potential for fingerprints and smudges. With dual-band Bluetooth and Wi-Fi, everything is connected from Mirror’s app on your smartphone. That way, you can also sync a heart-rate monitor or your Apple Watch to see your beats per minute in real time during workouts. Unfortunately, the app is compatible only with iOS devices for now.
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.
provides much-needed skills like critical thinking, analysis and problem-solving that people need in a rapidly evolving world.
Technology has undoubtedly and irreparably changed all aspects of our lives, from personal to professional. Unsurprisingly, it has also extended to many areas of healthcare, with research by the World Economic Forum (WEF) showing that between 2018 and 2022 there is an expected 87 percent adoption of user and entity big data analytics and 67 percent of Internet of Things, among others, in global health and healthcare.
This indicates widespread uptake of technology in the coming years and illustrates the need to incorporate technology in health education to ensure that the future workforce is adequately equipped, as well as to fully harness the power of technology to disrupt and improve the way individuals learn as we move deeper into the digital economy.
The disruptive and transformative power of technology in education is driven primarily by the fact that technology has the ability to make learning more interactive, collaborative and interesting. It also provides much-needed skills like critical thinking, analysis and problem-solving that people need in a rapidly evolving world.
Nursing and health sciences are, of course, not immune to the transformative capabilities of technology in education.The health industry is recognising more and more that it is critical for modern nurses and health practitioners to be highly trained and well-educated critical thinkers able to make complex clinical decisions – and there is an increasing recognition that the most effective way to produce these kinds of practitioners is to utilise technology in their education.
The transformative power of technology in nursing education
The Life College of Learning, which was established by Life Healthcare in 1998, has made technology and innovation its strategic focus for this reason and continuously implements programmes and initiatives that make use of the latest and most advanced technology.
Since 2013, for example, the college has upgraded the simulation rooms and digital education systems at each of its seven learning centres across the country so that innovative teaching and learning methodologies are used to promote student theory practice integration and improved cognitive thinking.As a result, the college now makes use of an advanced electronic learning programme that is conducive to learning and self-study as it is visual and interactive. The programme is a 3D human anatomy and physiology software used for teaching, learning and presenting.
Simulation, which is a vital part of healthcare training because of the ability to create real-world scenarios in a controlled and non-threatening environment, benefits broadly from the use of technology because tech facilitates the simulation of specific characteristics or behaviour of patients or illnesses.This allows students to get much-needed exposure to and practice life-saving skills without adverse consequences. These skills include basic and advanced nursing capabilities, a variety of wound care procedures, and labour, delivery and midwifery skills.
NHS £8.5 million by reducing the cost of treatment required and £138 million over five years thanks to reduced hospital admissions.
Not a day goes by without another headline bemoaning the lack of finance and resources that the NHS currently suffers from, but in a far corner of London a new accelerator scheme is trying to address that.
Incubating over 20 companies, the NHS has put together a Digital Health.London Accelerator to fast-track tools and software that could potentially help patients or supply savings to the already stretched public health service.
Adopting these innovations could be a way for the government to reduce spending on certain running costs, allowing for more investment in other areas of the service or to cut the deficit faced by the NHS on an annual basis.
And of course, there are other private studies already in operation in other parts of the NHS.
Here is a sneak peak of some of the tech-focused companies the scheme is currently working with:
Dr. Julian Medical Group Ltd aims to increase accessibility to mental health services, thus reducing waiting times. Patients with mental health problems have been proven to deteriorate if left untreated leading to higher cost. Individual sessions are more affordable too and could lead to savings of £29 million if 10% of treatments were undertaken via the platform.
Dr. Toolbox Ltd is an information service allowing for staff who are working in a different facility than they were trained in to access any necessary knowledge about the inner workings of the establishment. Developers estimate that the tool saves doctors an average of 40 minutes per day and could save the average hospital £200,000 per year.
Locum’s Nest is a platform that connects locum staff to temporary roles within NHS organizations. It is the first collaborative digital staff bank and has fill-rates of over 90% trust-wide resulting in cost savings of over £2.5 million each year.
Synopsis Healthcare provides a streamlined preoperative process using online assessment questionnaires. The screening aims to reduce the number of procedures canceled on the day. It is estimated that £65 million could be saved through the streamlining of the process, with 40% of low-risk patients no longer needing to attend an in-person preoperative appointment.
Healum Ltd allows patients to monitor their chronic physical or mental health condition in a cost-effective way. For example, with the help of the app, 150,000 patients have reduced their level of HBA1c by 1% or more. It is estimated this type of access to monitoring could save the NHS £8.5 million by reducing the cost of treatment required and £138 million over five years thanks to reduced hospital admissions.
Trakka Medical (HaMpton) uses an app to allow patients to monitor their blood pressure at home. The app alerts patients if they need to attend the hospital and also can be monitored by clinicians remotely. Use of the app resulted in a 53% reduction in the need for hypertension monitoring appointments and could save the NHS £50 million annually if scaled up across the country.
Trayned Insight Ltd analyses hundreds of performance and outcome measures in primary care which can be used to improve patient care, the effectiveness of treatment and cost efficiency. Use of the technology could save the NHS £700 million in drug prescriptions annually and would reduce the number of urgent care admissions by nearly 40,000 occurrences.
The number of active users, Simmons noted, thus relates to the quality of the ads and the inventory in a given network.
How the ranking was determined: The ranking is based on four metrics relating to ads that drive app installs, which is mostly what Kochava measures and assigns credit for.
They are signal clarity, fraud, quality and correlation (the statistical relationship between clicks and conversions) reported by the networks. Kochava integrates with 3000 or so mobile ad networks.
Signal clarity is the data surrounding clicks, impressions and postbacks. Head of Client Analytics Grant Simmons told me that networks sometimes only report clicks, for instance, and are less clear about related data, such as device ID, creative ID, transaction ID and so on. Postbacks are the data that Kochava returns to the network, relating to whether the ads led to app installs, and this data is used by networks for optimization.
The percent of fraudulent traffic is based on measurement via Kochava’s fraud console, and quality is how many active users the network retains. The number of active users, Simmons noted, thus relates to the quality of the ads and the inventory in a given network.
Other rankings: Simmons pointed to two other rankings of mobile ad networks, by attribution firms Appsflyer and Tune, although the latter’s attribution business is now owned by deep linking firm Branch. The difference in the rankings, he said, is that Kochava puts more emphasis on signal clarity, and thus on the quality of correlation between click and install.
Why this matters to marketers: “This [ranking] is an effort to clear up this industry,” Simmons said, adding that it is “remarkably fraudulent.”