Negotiating IT in the FDA Regulatory Environment

By Bruce Maches

April 26, 2010

All life science, food product, and cosmetic companies in the US must operate under the regulatory framework put forth by the Food & Drug Administration. In my first blog entry I briefly touched upon the subject of FDA regulatory compliance. This blog entry will dive deeper into this topic to give you a much clearer understanding of the regulatory environment that life sciences companies must labor under and what the IT groups in those organizations must deal with from a compliance standpoint. I will then discuss how this impacts the advance of cloud computing in life science companies along with some examples of current uses in my next entry.

Every life science company, whether bio-tech, big pharma or medical device, must navigate a complex sea of regulations, recommended practices and government mandates as part of their normal business activities. This can include SOX (for public companies) HIPPA2 (patient privacy for electronic records) and numerous FDA regulatory guidelines. All life science companies have some sort of internal regulatory affairs function that ensures FDA compliance across the entire organization focusing on research/laboratory practices, manufacturing processes, clinical trials, and the IT organization. The primary driver for IT regulatory practices that I will focus on is CFR 21 Part 11. One clarifying comment, the FDA, like many other regulatory bodies does not issue standards; instead it provides guidelines on what must be done to be considered compliant but not on the execution of how it is accomplished.

In a nutshell the Code for Federal Regulations 21 Part 11 defines how life science companies implement system controls, including audits, validation & verification processes, electronic signatures, and documentation for software and systems involved in processing electronic records. This primarily applies to systems dealing with research, drug development, manufacturing, clinical trials, regulatory submissions but not common systems such as the companies financial or HR applications. Part 11 compliance is done through an intensive validation process involving three primary steps which I will describe shortly. All of this effort is to ensure that processing activity and electronic records for a particular system are accurate and can be trusted. In addition the overall IT compliance environment includes the system support and maintenance procedures along with verifying that the personnel managing the system have the requisite skills and training to properly do so.

The key word here is trust – if I am an FDA auditor how do I know I can trust the operation and output of a particular system? Keep in mind that if you cannot prove something then to an auditor is did not happen. The actual Part 11 compliance process for any application includes the hardware, software and operational environment for the system itself. This allows an IT group to answer the questions:

Can I prove the system was installed correctly?

Can I prove the system is operating correctly?

Can I prove the system is performing correctly to meet the stated user requirements?

To prove these three things the system validation process has three primary components, the Installation Qualification (IQ), the Operational Qualification (OQ) and the Performance Qualification (PQ) scripts. These are extremely detailed documents laying out the individual steps involved in performing these three tasks. Each step has an expected outcome (i.e. click on OK and the dialog box disappears) which must be handwritten in, each line item initialed and every page signed. To give you an idea on how lengthy this process can be I recently installed an off the shelf document management package with no customization for a bio-tech client. The IQ document was a 1 inch stack of paper, the OQ filled two 3 inch binders, and the PQ was 2 inches of paper. I know this sounds quite exhausting but it is the process by which an auditor can be assured that the work was correctly done per spec. Any issues encountered during the execution of the scripts must be documented as deviations and then resolved with supporting information. In performing the IQ script, one of the standard pieces of information recorded is the model, type, configuration, and serial number of the computer on which the software is being installed which may not be applicable in a cloud computing environment.

I hope I haven’t bored you with all of the details but I wanted to give you more background on the environment in which FDA regulated companies must exist.

So the big question is how does this impact the acceptance of cloud computing based applications in life science companies? In my next blog entry I will discuss some of these questions:

How does the FDA currently view the use of cloud technologies?

Does the use of private vs. public cloud services affect Part 11 compliance?

Does the type of cloud service (IaaS, PaaS, and SaaS) being used impact the validation process?

What current examples are there of life science companies using cloud technologies?

How can cloud help life science companies deal with their inventory of legacy validated systems?
 

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!

SC Bids Farewell to Denver, Heads to Dallas for 30th

November 17, 2017

After a jam-packed four-day expo and intensive six-day technical program, SC17 has wrapped up another successful event that brought together nearly 13,000 visitors to the Colorado Convention Center in Denver for the larg Read more…

By Tiffany Trader

SC17 Keynote – HPC Powers SKA Efforts to Peer Deep into the Cosmos

November 17, 2017

This week’s SC17 keynote – Life, the Universe and Computing: The Story of the SKA Telescope – was a powerful pitch for the potential of Big Science projects that also showcased the foundational role of high performance computing in modern science. It was also visually stunning. Read more…

By John Russell

How Cities Use HPC at the Edge to Get Smarter

November 17, 2017

Cities are sensoring up, collecting vast troves of data that they’re running through predictive models and using the insights to solve problems that, in some cases, city managers didn’t even know existed. Speaking Read more…

By Doug Black

HPE Extreme Performance Solutions

Harness Scalable Petabyte Storage with HPE Apollo 4510 and HPE StoreEver

As a growing number of connected devices challenges IT departments to rapidly collect, manage, and store troves of data, organizations must adopt a new generation of IT to help them operate quickly and intelligently. Read more…

SC17 Student Cluster Competition Configurations: Fewer Nodes, Way More Accelerators

November 16, 2017

The final configurations for each of the SC17 “Donnybrook in Denver” Student Cluster Competition have been released. Fortunately, each team received their equipment shipments on time and undamaged, so the teams are r Read more…

By Dan Olds

SC Bids Farewell to Denver, Heads to Dallas for 30th

November 17, 2017

After a jam-packed four-day expo and intensive six-day technical program, SC17 has wrapped up another successful event that brought together nearly 13,000 visit Read more…

By Tiffany Trader

SC17 Keynote – HPC Powers SKA Efforts to Peer Deep into the Cosmos

November 17, 2017

This week’s SC17 keynote – Life, the Universe and Computing: The Story of the SKA Telescope – was a powerful pitch for the potential of Big Science projects that also showcased the foundational role of high performance computing in modern science. It was also visually stunning. Read more…

By John Russell

How Cities Use HPC at the Edge to Get Smarter

November 17, 2017

Cities are sensoring up, collecting vast troves of data that they’re running through predictive models and using the insights to solve problems that, in some Read more…

By Doug Black

Student Cluster LINPACK Record Shattered! More LINs Packed Than Ever before!

November 16, 2017

Nanyang Technological University, the pride of Singapore, utterly destroyed the Student Cluster Competition LINPACK record by posting a score of 51.77 TFlop/s a Read more…

By Dan Olds

Hyperion Market Update: ‘Decent’ Growth Led by HPE; AI Transparency a Risk Issue

November 15, 2017

The HPC market update from Hyperion Research (formerly IDC) at the annual SC conference is a business and social “must,” and this year’s presentation at S Read more…

By Doug Black

Nvidia Focuses Its Cloud Containers on HPC Applications

November 14, 2017

Having migrated its top-of-the-line datacenter GPU to the largest cloud vendors, Nvidia is touting its Volta architecture for a range of scientific computing ta Read more…

By George Leopold

HPE Launches ARM-based Apollo System for HPC, AI

November 14, 2017

HPE doubled down on its memory-driven computing vision while expanding its processor portfolio with the announcement yesterday of the company’s first ARM-base Read more…

By Doug Black

OpenACC Shines in Global Climate/Weather Codes

November 14, 2017

OpenACC, the directive-based parallel programming model used mostly for porting codes to GPUs for use on heterogeneous systems, came to SC17 touting impressive Read more…

By John Russell

US Coalesces Plans for First Exascale Supercomputer: Aurora in 2021

September 27, 2017

At the Advanced Scientific Computing Advisory Committee (ASCAC) meeting, in Arlington, Va., yesterday (Sept. 26), it was revealed that the "Aurora" supercompute Read more…

By Tiffany Trader

NERSC Scales Scientific Deep Learning to 15 Petaflops

August 28, 2017

A collaborative effort between Intel, NERSC and Stanford has delivered the first 15-petaflops deep learning software running on HPC platforms and is, according Read more…

By Rob Farber

Oracle Layoffs Reportedly Hit SPARC and Solaris Hard

September 7, 2017

Oracle’s latest layoffs have many wondering if this is the end of the line for the SPARC processor and Solaris OS development. As reported by multiple sources Read more…

By John Russell

Nvidia Responds to Google TPU Benchmarking

April 10, 2017

Nvidia highlights strengths of its newest GPU silicon in response to Google's report on the performance and energy advantages of its custom tensor processor. Read more…

By Tiffany Trader

Google Releases Deeplearn.js to Further Democratize Machine Learning

August 17, 2017

Spreading the use of machine learning tools is one of the goals of Google’s PAIR (People + AI Research) initiative, which was introduced in early July. Last w Read more…

By John Russell

GlobalFoundries Puts Wind in AMD’s Sails with 12nm FinFET

September 24, 2017

From its annual tech conference last week (Sept. 20), where GlobalFoundries welcomed more than 600 semiconductor professionals (reaching the Santa Clara venue Read more…

By Tiffany Trader

Amazon Debuts New AMD-based GPU Instances for Graphics Acceleration

September 12, 2017

Last week Amazon Web Services (AWS) streaming service, AppStream 2.0, introduced a new GPU instance called Graphics Design intended to accelerate graphics. The Read more…

By John Russell

AMD Showcases Growing Portfolio of EPYC and Radeon-based Systems at SC17

November 13, 2017

AMD’s charge back into HPC and the datacenter is on full display at SC17. Having launched the EPYC processor line in June along with its MI25 GPU the focus he Read more…

By John Russell

Leading Solution Providers

EU Funds 20 Million Euro ARM+FPGA Exascale Project

September 7, 2017

At the Barcelona Supercomputer Centre on Wednesday (Sept. 6), 16 partners gathered to launch the EuroEXA project, which invests €20 million over three-and-a-half years into exascale-focused research and development. Led by the Horizon 2020 program, EuroEXA picks up the banner of a triad of partner projects — ExaNeSt, EcoScale and ExaNoDe — building on their work... Read more…

By Tiffany Trader

Reinders: “AVX-512 May Be a Hidden Gem” in Intel Xeon Scalable Processors

June 29, 2017

Imagine if we could use vector processing on something other than just floating point problems.  Today, GPUs and CPUs work tirelessly to accelerate algorithms Read more…

By James Reinders

Delays, Smoke, Records & Markets – A Candid Conversation with Cray CEO Peter Ungaro

October 5, 2017

Earlier this month, Tom Tabor, publisher of HPCwire and I had a very personal conversation with Cray CEO Peter Ungaro. Cray has been on something of a Cinderell Read more…

By Tiffany Trader & Tom Tabor

Cray Moves to Acquire the Seagate ClusterStor Line

July 28, 2017

This week Cray announced that it is picking up Seagate's ClusterStor HPC storage array business for an undisclosed sum. "In short we're effectively transitioning the bulk of the ClusterStor product line to Cray," said CEO Peter Ungaro. Read more…

By Tiffany Trader

Intel Launches Software Tools to Ease FPGA Programming

September 5, 2017

Field Programmable Gate Arrays (FPGAs) have a reputation for being difficult to program, requiring expertise in specialty languages, like Verilog or VHDL. Easin Read more…

By Tiffany Trader

HPC Chips – A Veritable Smorgasbord?

October 10, 2017

For the first time since AMD's ill-fated launch of Bulldozer the answer to the question, 'Which CPU will be in my next HPC system?' doesn't have to be 'Whichever variety of Intel Xeon E5 they are selling when we procure'. Read more…

By Dairsie Latimer

IBM Advances Web-based Quantum Programming

September 5, 2017

IBM Research is pairing its Jupyter-based Data Science Experience notebook environment with its cloud-based quantum computer, IBM Q, in hopes of encouraging a new class of entrepreneurial user to solve intractable problems that even exceed the capabilities of the best AI systems. Read more…

By Alex Woodie

How ‘Knights Mill’ Gets Its Deep Learning Flops

June 22, 2017

Intel, the subject of much speculation regarding the delayed, rewritten or potentially canceled “Aurora” contract (the Argonne Lab part of the CORAL “ Read more…

By Tiffany Trader

  • arrow
  • Click Here for More Headlines
  • arrow
Share This