Cloud Infrastructure and FDA Compliance

By Bruce Maches

May 5, 2010

In my first blog entry I provided background on some of the issues life sciences companies are facing and the potential for cloud computing in dealing with these challenges. In my previous blog entry I provided a high level overview of the extensive system validation and verification process required by the FDA regulatory guidelines. This entry will focus on the infrastructure services side of cloud computing. I will also discuss how the aspects of public versus private cloud impacts the approach for implementing cloud computing in the life sciences. I have already received feedback from a number of you and the regulatory compliance topic seems to be of the most interest so I will focus my next few entries on cloud services and FDA compliance.
 
As mentioned in my prior post, CFR 21 Part 11 validation is a basic fact of life for FDA regulated companies. While my focus is and will continue to be on the life sciences, the FDA also provides the regulatory framework that food and cosmetics companies must adhere to. Many of the challenges faced by these companies are the same that life science companies are dealing with. This includes such items as product recalls, lot traceability, clinical testing studies, and managing product manufacturing.
 
So – how does the cloud infrastructure paradigm align with the FDA regulatory compliance model? Part 11 validation outcome is all about ensuring system quality and to be able to trust that the system in question was installed, operates, and performs correctly. Keep in mind that the FDA, like similar regulatory bodies, doesn’t tell you ‘this is how you must do things’ what they do is state ‘this is what needs to be done’ and it is up to you to prove that you are meeting the guidelines as stated. If you went to the FDA and said ‘we want to leverage cloud for this new system we are implementing’ they would not tell you how to do it and if it would be accepted or not. They would simply point to CFR 21 Part 11 and say ‘if you meet those standards it is acceptable’. That is not something you want to gamble on after investing significant funds in a new cloud based system that must be validated.
 
Since the Installation Qualification (IQ) document covers the infrastructure piece we can concentrate on how to support IQ validation requirements while attempting to utilize cloud based infrastructure and the differences between private and public environments.
 
An IQ document contains a complete set of detailed information on the hardware environment, the underlying software (from OS to application) and instructions on how to install the system from out of the box. A significant amount of this information is captured simply to avoid the risk of failing an audit and these procedures were originated prior to the advent of cloud computing. Some of the items recorded as part of the IQ script normally include:
 
• Hardware serial number
• System configuration
• Equipment location
• Exact versions off all installed software
 
Of course you can see that with public cloud services there are already some issues. In a public cloud offering there is no way to know the detailed information on the hardware and software that your system will be running on or even the exact location of the system itself. In the current way of approaching the IQ validation process, public cloud computing is just not a viable option for these types of applications. Until regulatory auditors can handle not knowing the hardware configuration and location it is just too big a risk to attempt to put a validated application into the public cloud and hope you can pass any potential regulatory audit. That doesn’t mean that a life science company couldn’t use public cloud provisioned infrastructure for non-validated applications and many are doing so now.
 
Now for private cloud the situation can be different if, and it is a big if, the provider of the public cloud is willing to go through the time and expense to pre-validate their entire environment prior to loading any real applications. This would mean creating and executing an IQ document for each server/OS configuration installed in the private cloud. While this sounds like a lot of work, it would be manageable if the private cloud environment were to be completely homogenous from both a hardware and system software standpoint. You would create one IQ document template and execute it for each separate server being installed. This way you could record the hardware information and software installation configuration for every machine. The drawback to this is that every potential user of this validated environment would need their applications to fit into this ‘one size fits all’ offering limiting its appeal to potential clients.
 
Another approach would be to create a certain base level of validation for the private cloud environment. In other words, validate the hardware piece and common software components through the IQ process. The data center operator could then create pre-qualified machine images with all of the supporting documentation which could then be ordered by the client to fit their particular needs. These machine images could include various operating systems, database engines or other supporting software. These would have been through a qualification process meaning that most of the IQ portion is complete with only minor client unique portions remaining. A client could then pick the most appropriate machine image for their needs with supporting documentation and most of the IQ complete. They would then only need to go through the IQ process for those pieces necessary to meet their specific needs.  
 
So – in a nutshell, the public cloud model just does not fit, at this time, the current practices for validation in FDA regulated companies. However the private cloud environment could be leveraged to provide life science companies with a short-cut to completing overall system validation. Any cloud infrastructure provider willing to put in the up-front effort will find they have a solution that would be very appealing to FDA regulated companies looking to be more efficient with their IT dollars. I am actually in the process of starting this effort with a large managed services provider and will keep you updated on how it works out.
 
In my next entry I will discuss how infrastructure as a service can be used to lower costs and increase speed to market for life science companies. I will also provide some examples of what is being done currently in the industry.
 
Feel free to contact me at [email protected]

Subscribe to HPCwire's Weekly Update!

Be the most informed person in the room! Stay ahead of the tech trends with industy updates delivered to you every week!

What’s New in Computing vs. COVID-19: Fugaku, Congress, De Novo Design & More

July 2, 2020

Supercomputing, big data and artificial intelligence are crucial tools in the fight against the coronavirus pandemic. Around the world, researchers, corporations and governments are urgently devoting their computing reso Read more…

By Oliver Peckham

OpenPOWER Reboot – New Director, New Silicon Partners, Leveraging Linux Foundation Connections

July 2, 2020

Earlier this week the OpenPOWER Foundation announced the contribution of IBM’s A21 Power processor core design to the open source community. Roughly this time last year, IBM announced open sourcing its Power instructio Read more…

By John Russell

HPC Career Notes: July 2020 Edition

July 1, 2020

In this monthly feature, we'll keep you up-to-date on the latest career developments for individuals in the high-performance computing community. Whether it's a promotion, new company hire, or even an accolade, we've got Read more…

By Mariana Iriarte

Supercomputers Enable Radical, Promising New COVID-19 Drug Development Approach

July 1, 2020

Around the world, innumerable supercomputers are sifting through billions of molecules in a desperate search for a viable therapeutic to treat COVID-19. Those molecules are pulled from enormous databases of known compoun Read more…

By Oliver Peckham

HPC-Powered Simulations Reveal a Looming Climatic Threat to Vital Monsoon Seasons

June 30, 2020

As June draws to a close, eyes are turning to the latter half of the year – and with it, the monsoon and hurricane seasons that can prove vital or devastating for many of the world’s coastal communities. Now, climate Read more…

By Oliver Peckham

AWS Solution Channel

Maxar Builds HPC on AWS to Deliver Forecasts 58% Faster Than Weather Supercomputer

When weather threatens drilling rigs, refineries, and other energy facilities, oil and gas companies want to move fast to protect personnel and equipment. And for firms that trade commodity shares in oil, precious metals, crops, and livestock, the weather can significantly impact their buy-sell decisions. Read more…

Intel® HPC + AI Pavilion

Supercomputing the Pandemic: Scientific Community Tackles COVID-19 from Multiple Perspectives

Since their inception, supercomputers have taken on the biggest, most complex, and most data-intensive computing challenges—from confirming Einstein’s theories about gravitational waves to predicting the impacts of climate change. Read more…

Hyperion Forecast – Headwinds in 2020 Won’t Stifle Cloud HPC Adoption or Arm’s Rise

June 30, 2020

The semiannual taking of HPC’s pulse by Hyperion Research – late fall at SC and early summer at ISC – is a much-watched indicator of things come. This year is no different though the conversion of ISC to a digital Read more…

By John Russell

OpenPOWER Reboot – New Director, New Silicon Partners, Leveraging Linux Foundation Connections

July 2, 2020

Earlier this week the OpenPOWER Foundation announced the contribution of IBM’s A21 Power processor core design to the open source community. Roughly this time Read more…

By John Russell

Hyperion Forecast – Headwinds in 2020 Won’t Stifle Cloud HPC Adoption or Arm’s Rise

June 30, 2020

The semiannual taking of HPC’s pulse by Hyperion Research – late fall at SC and early summer at ISC – is a much-watched indicator of things come. This yea Read more…

By John Russell

Racism and HPC: a Special Podcast

June 29, 2020

Promoting greater diversity in HPC is a much-discussed goal and ostensibly a long-sought goal in HPC. Yet it seems clear HPC is far from achieving this goal. Re Read more…

Top500 Trends: Movement on Top, but Record Low Turnover

June 25, 2020

The 55th installment of the Top500 list saw strong activity in the leadership segment with four new systems in the top ten and a crowning achievement from the f Read more…

By Tiffany Trader

ISC 2020 Keynote: Hope for the Future, Praise for Fugaku and HPC’s Pandemic Response

June 24, 2020

In stark contrast to past years Thomas Sterling’s ISC20 keynote today struck a more somber note with the COVID-19 pandemic as the central character in Sterling’s annual review of worldwide trends in HPC. Better known for his engaging manner and occasional willingness to poke prickly egos, Sterling instead strode through the numbing statistics associated... Read more…

By John Russell

ISC 2020’s Student Cluster Competition Winners Announced

June 24, 2020

Normally, the Student Cluster Competition involves teams of students building real computing clusters on the show floors of major supercomputer conferences and Read more…

By Oliver Peckham

Hoefler’s Whirlwind ISC20 Virtual Tour of ML Trends in 9 Slides

June 23, 2020

The ISC20 experience this year via livestreaming and pre-recordings is interesting and perhaps a bit odd. That said presenters’ efforts to condense their comments makes for economic use of your time. Torsten Hoefler’s whirlwind 12-minute tour of ML is a great example. Hoefler, leader of the planned ISC20 Machine Learning... Read more…

By John Russell

At ISC, the Fight Against COVID-19 Took the Stage – and Yes, Fugaku Was There

June 23, 2020

With over nine million infected and nearly half a million dead, the COVID-19 pandemic has seized the world’s attention for several months. It has also dominat Read more…

By Oliver Peckham

Supercomputer Modeling Tests How COVID-19 Spreads in Grocery Stores

April 8, 2020

In the COVID-19 era, many people are treating simple activities like getting gas or groceries with caution as they try to heed social distancing mandates and protect their own health. Still, significant uncertainty surrounds the relative risk of different activities, and conflicting information is prevalent. A team of Finnish researchers set out to address some of these uncertainties by... Read more…

By Oliver Peckham

[email protected] Turns Its Massive Crowdsourced Computer Network Against COVID-19

March 16, 2020

For gamers, fighting against a global crisis is usually pure fantasy – but now, it’s looking more like a reality. As supercomputers around the world spin up Read more…

By Oliver Peckham

[email protected] Rallies a Legion of Computers Against the Coronavirus

March 24, 2020

Last week, we highlighted [email protected], a massive, crowdsourced computer network that has turned its resources against the coronavirus pandemic sweeping the globe – but [email protected] isn’t the only game in town. The internet is buzzing with crowdsourced computing... Read more…

By Oliver Peckham

Global Supercomputing Is Mobilizing Against COVID-19

March 12, 2020

Tech has been taking some heavy losses from the coronavirus pandemic. Global supply chains have been disrupted, virtually every major tech conference taking place over the next few months has been canceled... Read more…

By Oliver Peckham

Supercomputer Simulations Reveal the Fate of the Neanderthals

May 25, 2020

For hundreds of thousands of years, neanderthals roamed the planet, eventually (almost 50,000 years ago) giving way to homo sapiens, which quickly became the do Read more…

By Oliver Peckham

DoE Expands on Role of COVID-19 Supercomputing Consortium

March 25, 2020

After announcing the launch of the COVID-19 High Performance Computing Consortium on Sunday, the Department of Energy yesterday provided more details on its sco Read more…

By John Russell

Steve Scott Lays Out HPE-Cray Blended Product Roadmap

March 11, 2020

Last week, the day before the El Capitan processor disclosures were made at HPE's new headquarters in San Jose, Steve Scott (CTO for HPC & AI at HPE, and former Cray CTO) was on-hand at the Rice Oil & Gas HPC conference in Houston. He was there to discuss the HPE-Cray transition and blended roadmap, as well as his favorite topic, Cray's eighth-gen networking technology, Slingshot. Read more…

By Tiffany Trader

Honeywell’s Big Bet on Trapped Ion Quantum Computing

April 7, 2020

Honeywell doesn’t spring to mind when thinking of quantum computing pioneers, but a decade ago the high-tech conglomerate better known for its control systems waded deliberately into the then calmer quantum computing (QC) waters. Fast forward to March when Honeywell announced plans to introduce an ion trap-based quantum computer whose ‘performance’ would... Read more…

By John Russell

Leading Solution Providers

Contributors

Neocortex Will Be First-of-Its-Kind 800,000-Core AI Supercomputer

June 9, 2020

Pittsburgh Supercomputing Center (PSC - a joint research organization of Carnegie Mellon University and the University of Pittsburgh) has won a $5 million award Read more…

By Tiffany Trader

‘Billion Molecules Against COVID-19’ Challenge to Launch with Massive Supercomputing Support

April 22, 2020

Around the world, supercomputing centers have spun up and opened their doors for COVID-19 research in what may be the most unified supercomputing effort in hist Read more…

By Oliver Peckham

Australian Researchers Break All-Time Internet Speed Record

May 26, 2020

If you’ve been stuck at home for the last few months, you’ve probably become more attuned to the quality (or lack thereof) of your internet connection. Even Read more…

By Oliver Peckham

15 Slides on Programming Aurora and Exascale Systems

May 7, 2020

Sometime in 2021, Aurora, the first planned U.S. exascale system, is scheduled to be fired up at Argonne National Laboratory. Cray (now HPE) and Intel are the k Read more…

By John Russell

Nvidia’s Ampere A100 GPU: Up to 2.5X the HPC, 20X the AI

May 14, 2020

Nvidia's first Ampere-based graphics card, the A100 GPU, packs a whopping 54 billion transistors on 826mm2 of silicon, making it the world's largest seven-nanom Read more…

By Tiffany Trader

10nm, 7nm, 5nm…. Should the Chip Nanometer Metric Be Replaced?

June 1, 2020

The biggest cool factor in server chips is the nanometer. AMD beating Intel to a CPU built on a 7nm process node* – with 5nm and 3nm on the way – has been i Read more…

By Doug Black

Summit Supercomputer is Already Making its Mark on Science

September 20, 2018

Summit, now the fastest supercomputer in the world, is quickly making its mark in science – five of the six finalists just announced for the prestigious 2018 Read more…

By John Russell

TACC Supercomputers Run Simulations Illuminating COVID-19, DNA Replication

March 19, 2020

As supercomputers around the world spin up to combat the coronavirus, the Texas Advanced Computing Center (TACC) is announcing results that may help to illumina Read more…

By Staff report

  • arrow
  • Click Here for More Headlines
  • arrow
Do NOT follow this link or you will be banned from the site!
Share This