February 4, 2012

CDRH 2012 Strategic Priorities Emphasize QA, Life Cycle Management

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Deciphering the FDA is a bit like trying to understand what the old USSR was up to in the days of the Cold War.  In those days, it was called Kremlinology, or the study of a complex, secretive organization.  We need a catchphrase for those of us today who try to figure out what the FDA means when it says something, or what it means when it says nothing, or what it means when it tells you what it means. You get the idea.

The FDA has been talking a lot of late about transparency. Its 2011 initiative is an agency attempt, it says, to open up about how it does business. FDA is accepting comments on it until February 28.  The jury is still out on whether this initiative will accomplish much.

Our latest piece of FDA evidence is CDRH’s 2012 Strategic Priorities.

CDRH devotes the Introduction of the document about looking ahead to patting itself on the back for its 2011 achievements, e.g. its report, “Understanding Barriers to Medical Device Quality,” that reviews the challenges that the FDA and industry face in supporting well‐integrated, best‐quality manufacturing practices and strategies that industry and the FDA can take to overcome these barriers.

CDRH also reminds us that “to complete this work [in 2011] our staff went above and beyond their already demanding workload. This is a remarkable achievement.”

Good to know.

In 2012, CDRH says it will continue to emphasize four priority areas:

  1. Fully Implement a Total Product Life Cycle Approach
  2. Enhance Communication and Transparency
  3. Strengthen Its Workforce and Workplace
  4. Proactively Facilitate Innovation to Address Unmet Public Health Needs

CDRH promises in 2012 to “improve” its premarket programs. By April 1, it pledges to begin its Triage of Pre-market Submissions Pilot to “increase submission review efficiency and better manage the pre-market review workload.”

And by the end of the year, CDRH pledges to publish a proposed rule to clarify the circumstances under which it could rely on clinical studies conducted in and for other countries. CDRH also says it will finalize all guidance documents it has issued as part of its overall plan to improve its premarket programs.

We’ll keep an eye on these and other promises throughout the year and report back as FDA hits or misses its own targets.

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Lilly CEO Calls on FDA to Lighten Up

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA has to speed up adoption of a “Benefit-Risk Framework” to improve decision-making in the regulatory process, said John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company.

Speaking at recent industry conference, the CEO of the drug giant called for a regulatory process that focuses both on recognizing and appreciating benefits while identifying and minimizing risks. Such a balanced approach would help increase the flow of needed medicines to patients and reverse a trend of fewer new drugs getting approved, he said.

“The stakes are high,” Lechleiter said. “The only way to make inroads against [chronic and other] diseases is to sustain the pace of medical progress.”

The FDA appears to be a bit on the defensive here. It recently issued a report touting its record approving drugs it says demonstrates it isn’t stifling innovation at all thank you very much.

The backdrop to this battle is the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA) V. Originally enacted in 1992, PDUFA and its iterations set the foundation for how FDA will manage the drug review process for five years, beginning in October 2012.

Lilly’s Lechleiter stressed the importance of a non-partisan course for reauthorization. “As a basis for the drug review process, PDUFA is too important to get bogged down in partisan politics,” Lechleiter said. “As Congress considers reauthorization next year, we hope to see a ‘clean’ bill – one free of extraneous and controversial provisions that would politicize the bill and further complicate matters for all parties.”Lechleiter said the regulatory system must continue to evolve to meet 21st century needs.

Lechleiter offered five key characteristics of a “state of the art” regulatory approval system:

  1. Timely – “There are far too many conditions for which therapy is inadequate or nonexistent. We need a system that is not only effective, but efficient as well.”
  2. Predictable – “The system must be predictable in its judgments, its decisions, and the criteria on which those decisions were based – whether scientific, ethical, legal, etc.”
  3. Consistent – “The system must be consistent across review divisions using standardization and repeatable processes – so that an innovator clearly understands the regulatory requirements and so that institutional learning can be harnessed to replace time-consuming one-off learning by review groups and division.”
  4. Transparent – “The system needs to be transparent in its judgments and criteria so [stakeholders] understand the rationale for its decisions.”
  5. Scientifically rigorous – “This requires scientific expertise within the agency – or access to the expertise – that understands, engages in, and influences the constantly evolving external scientific environment and ensures that standards are up-to-date.”

Lechleiter also discussed ways to strengthen a medicine’s benefit and lower its risk, including calling for greater emphasis on improved outcomes for individual patients, through the development of tailored therapeutics.

“From the point of view of patients and their doctors, a tailored therapy will provide a better benefit/risk trade-off, because they can have a higher degree of confidence that it will work effectively and with minimal harmful side-effects relative to the benefit obtained,” said Lechleiter. “From a value-for-money standpoint, tailored medicines should also reduce the heavy costs associated with non-responders. In other words, payers will get what they are paying for.”

Cry havoc and let slip the dogs of war. This one isn’t over by a long-shot.

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Quality by Design (QbD) Pilot Presents Industry With New Challenges

Patrick Stone, President, TradeStone QA

What products will be affected by QbD? It will apply to new Marketing Authorization Applications (MAAs)/New Drug Applications (NDAs), Type II Variations/Prior-approval supplements (sNDA) and Scientific Advice requests/CMC formal meeting request that include QbD/PAT elements and are submitted to FDA & EU new applications, for MAAs/NDAs where the sponsor/applicant has agreed to a parallel evaluation by both agencies.

Upon request from the sponsor/applicant, and where procedural time-lines will allow, Type II Variations/NDAs may also be considered on a case by case basis. Right now this is a voluntary pilot with some pharma companies being tapped or nudged by FDA & EMA to join in.

Our geographically diverse health product market involves more contracting and outsourcing for many product components. Finished product real time testing and design space requirements will be crucial for implementing QbD.  ICH third party QA mandates will result from this pilot program.

QbD products will be as unique as the individuals who receive them (personalized medicine). This new model may impact two-thirds of the new health care products in the pipeline (cell therapies, gene therapies, and molecular entity therapy).   There will be many approaches to high order characterization and some are not cost effective at present.  Many of the details will take years to sort out. Collaborations between the FDA, Japan Ministry of Health, and  European Medicines agency will require funding along with mutual scientific trust.

Emerging technologies and laboratory techniques will be required to accomplish the QbD paradigm shift. FDA can’t continue using the chemistry approval model for biotechnology products.  This paradigm shift may increase development times and cost structures.  The ICH model will also bring mandatory third party QA review so prepare your models for this as well.

Here are the essential points to focus on for QbD products:

  1. Target the product profile,
  2. Determine CQAs (Critical Quality Attributes),
  3. Link raw material attributes and process parameters to CQAs,
  4. Risk assessment,
  5. Develop a design space,
  6. Design and implement a control strategy.

Generic Drug TabletThe biotechnology sector QbD product development focus will be on design space and real time release testing. The pilot discussion focus for both regulatory agencies will be on ensuring consistent implementation of ICH Q8, Q9, and Q10 guidelines in the assessment process and to facilitate sharing of regulatory discretion & new regulatory concepts manufacturers of small-molecule generic drugs have concerns the initial lag-time in course correcting for the QbD initiative may exponentially delay the application file time for their products.

It appears some generic-drug manufacturers are not willing to implement any QbD concepts until closer to final harmonization and discussion time frames.

Why do you need higher order structure modeling?  Higher order structure product applicants will have to provide protein folding kinetics models with characterization integration into the application and annual report.  Your research models and early development modeling may be progressed for this function. Personalized medicine with batch to batch consistency including stability of 1-90 days is recommended. There are also talking points about including variants and aggregates of your products in the higher order structure models.  Intra and inter chain disulfide bonding, aggregation, and complete polypeptide modeling may be requested application material.

This may prove to be more cost effective while two juggernauts (FDA & EMA) iron out the red tape that will flow from this type of global initiative.  If the funds necessary to make this effort progress are not available on the FDA or EMA, side delays in the process are inevitable.

Molecular and personalized medicine can’t continue to be reviewed with the FDA chemical entity systems approach, approval model.   Effective cancer therapies and molecular medicine may not have the statistical significance necessary when only a handful of patients are treated with the cell or gene therapy.

Warning to Industry: FDA will obviously not let you have your cake and eat it too.  Innovate inevitable change by comments to FDA or accept the QbD change that is inevitable.   Your comments to the FDA will be monitored on the FDA’s Facebook page and current open comment requests. Contact your respective FDA liaison or center contact for discussion points directly related to your product.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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How to Handle NERC’s Risk-Based Reliability Compliance Monitoring

Vice President, Energy & Utilities Compliance, AssurX Inc.

As the Electric Reliability Organization (ERO) enters it’s fourth year as a mandatory entity, NERC and the Regional Entities have been working with the registered entities, FERC, and other stakeholders to improve reliability.  One of the latest topics being discussed at reliability workshops and meetings is the implementation of Risk-Based Reliability Compliance Monitoring.  What does this mean to a registered entity and how best to prepare for this change?

NERC and the Regional Entities have gathered enough data over the last four years to start the assessment to develop a risk-based reliability program.  Many mature industries have adopted the same type of approach in the past.  NERC has started to identify the core set of critical reliability standards to be audited and what areas are most crucial for reliability.  NERC has also been working over the years to assist registered entities on how to build strong compliance programs and what it takes to implement a culture of compliance within an organization.

NERC has identified some of the criteria to start developing a Risk-Based Reliability program, they include:

  • NERC top 20 list of allegedly violated reliability standards
  • High Violation Risk Factor (VRF)
  • Violation Risk Index (VRI)
  • Past reliability events and major reliability issues
  • Input from Regional Entities; especially from the audit teams and enforcement groups
  • Assessment of registered entities compliance program and compliance culture

Some Regional Entities are developing their own Compliance Surveys that will be sent out to their registered entities.  AssurX Compliance Services division has developed a white-paper outlining some of the key issues an organization should focus on to build an internal culture of compliance.  As the ERO matures, more attention should focus on sharing lessons-learned from events, improving critical reliability standards, and how a registered entity mitigates identified issues.

We will be writing more about the Risk-based Reliability Compliance monitoring program in future weeks.  Review our white-paper and contact us if you have more questions.

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How Risky is Risk for FDA-Regulated Life Sciences Companies?

Russ King, Managing Partner, Methodsense

The simple word “Risk” is certainly one of the most frequently used terms in the contemporary Compliance Lexicon. It has become a cliché to say that the FDA advocates a “risk based approach.” Risk Management, Risk Assessment and Risk Mitigation are staples on the menus of virtually every life science conference and exhibition. Life Science publications behave similarly and as a case in point the tag line of the AssurX Blog site is “Compliance, quality and risk: Straight talk for regulated industries” (emphasis mine).

But what the heck is “risk”? Should the very nature of “risk” in and of itself really matter to life science companies on a level beyond scenarios of potential harm, SOP creation and record generation?

First, the (sophomoric) exercise of reviewing alternative definitions of risk to get us started:

  • risk = an unwanted event which may or may not occur.
  • risk = the cause of an unwanted event which may or may not occur.
  • risk = the probability of an unwanted event which may or may not occur.
  • risk = the statistical expectation value of an unwanted event which may or may not occur.
  • risk = the fact that a decision is made under conditions of known probabilities (“decision under risk” as opposed to “decision under uncertainty”)

All of these definitions, as well as others, have a couple of things in common: risk involves unwanted consequences and uncertainty. Obvious, right? (Remember this was a sophomoric exercise). Nevertheless, it is interesting to note that unwanted consequences and uncertainty are something we humans tend to fear and hate. Uncertainty is also generally unpopular with humans.

Now consider this within the context of a medical device, pharmaceutical or biotechnology company. Among the passions driving life science companies is scientific knowledge (humans love knowing) and the practical execution of knowledge on behalf of at least two other passions: improving the length and quality of our lives (something humans generally endorse on a wholesale basis) and economic success (a value that is a tad more controversial, but still generally endorsed by most of us). Not surprisingly, these two values are intimately connected: if a life science company can successfully improve our lives, we tend to be willing to pay for it.

Recall now that element of risk called ‘uncertainty’. Uncertainty seems to be diametrically opposed to knowledge, a core value of a science based endeavor. Uncertainty seems at cross purposes to the other passions of life science companies. There is nothing like the uncertainty about the performance of devices or drugs to keep them out of the market or drive buyers away. (But isn’t that the way things should work?)

How a life science company responds to uncertainty will tell you a lot. We have seen fear, fearlessness, dissembling behavior, aggressive truth seeking….you name it and everything in between.

Uncertainty has the powerful ability to threaten everything built by the driving passions of a life science company from market share to profitability. No wonder the reactions to uncertainty vary so greatly from organization to organization. But there is something special about uncertainty and the advocacy of a risk based approach that should be strongly embraced by life science companies.

Confronting and overcoming uncertainty means that at a level much deeper than SOPs and Quality Records we gain knowledge, the very kind of knowledge that fuels the passions of contributing to our welfare and success. Assessing and understanding risk, managing risk and mitigating risk accomplishes this by delivering a better understanding of a company’s products, their manufacture, new products, better operations, etc. which invariably creates greater opportunities to improve our lives and enhance our wealth.

Yes, peeling back the veil of uncertainty can reveal the possibility or even the probability of unwanted consequences. It is very difficult to keep the ‘bad’ out of everything. But the strength of successful life science companies comes from what they know, when they know it, and what they do with that knowledge. The more skillfully life science companies look for, root out, and drag risks into the appropriate (not just any) well lit forum, the more uncertainty is condemned to understanding. Consequently, the opportunity to forestall the possibility or reduce the probability of unwanted consequences improves dramatically.

In other words, risk is a lot more risky if you take the risk of not facing it.

Russ King is Managing Partner at MethodSense, Inc.

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Are The NERC Requirements Strong Enough To Protect The Power Grid?

James Holler, Founder, Abidance Consulting

The NERC requirements might help the people at NERC and the regions get a better night’s sleep, but a sound action plan, including situational awareness, is the only true way to get there — and ensure greater cybersecurity for all.

With so much at stake, NERC is faced with a daunting challenge of locking down the nation’s cyber infrastructure as it pertains to the power grid. NERC has forced registered entities to establish programs for securing their Critical Assets and Critical Cyber Assets that includes dedicated management, oversight, accountability of corporate officers, processes for securing IT systems, and mechanisms for measuring progress.

Of course, just meeting NERC requirements doesn’t mean a registered entity is secure. NERC should recognize its shortcomings and pass a measure that will, among other things, strengthen the role of an industry recognized leader like the National Institute of Standards and Technology in shaping cybersecurity requirements.

So, why is cybersecurity such a challenge? That’s a loaded question because today’s information infrastructure is a quandary. Some of the issues are:

Advanced Persistent Threat

Cyber criminals have become more sophisticated, outpacing defensive measures. Hackers constantly exploit weaknesses in popular products and create new techniques using viruses, rogue antivirus software, keystroke loggers, botnets, and other tools, for immediate targets or time-triggered actions.

New Dynamics

Registered entities have completely changed the way they communicate, interact and accomplish their missions. They’re sharing information in new, amazing and sometimes scary ways—from portals (regional scale for the most part) to social networking websites like LinkedIn. They’re even bringing trusted third parties into the fold. And their flexible IT model is establishing technology options that could present more risks, such as mobility and cloud computing.

Shared Risk

All of this is extending NERC’s reach into the critical infrastructure. Yet, 95% of that infrastructure is in the hands of the private sector. Risk to that infrastructure, information assets and private data is rampant with potentially deep and catastrophic consequences. The fact is, registered entities are giving more and more access to data and applications, a concept that runs counter to most security type of thinking. Traditional network security that relies on reactive measures simply isn’t enough.

Pay Closer Attention To Applications

Whether off-the-shelf or home-grown, most applications are not engineered with security in mind, so you need to ensure trusted development processes to maintain their integrity. Today, that means adhering to requirements set-forth by the NERC requirements. Trusted delivery is also critical — especially with innovations like cloud computing. Protecting the perimeter around applications is not a sufficient defense and you must extend security to the application layer. In every case, you need to be able to measure an application’s ability to process and handle sensitive information throughout its deployment lifecycle.

James Holler is founder of Abidance Consulting.

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Part II: Protect Your Data and Your Company From an Internal or External “Hack-Attack”

James Holler, Founder, Abidance Consulting

In Part 1 of this series, we touched on some ways to make it so difficult to pull off a hack-attack, that the perpetrator will most likely want to go somewhere else and try their attack.

In this section, we’re going to address testing, maintaining and other important items that deserve your attention.

Testing

Once you have fixed all of the issues, you need to test everything to make sure it works the way it is supposed to. You must first create benchmarks in which you are testing against. Just to run a test for the sake of running a test is futile. Once the benchmark(s) have been set, you are ready to test:

  • Run port scans to ensure only required ports and services are open and/or running
  • Firewalls detect intrusions
  • Switches and routers have only active administrator accounts
  • Passwords adhere to compliance requirements etc

Be sure to document your test procedure(s) step-by-step as well as the test results. Note if the outcome of the test was expected or not. If there is anything that fails during your testing, you need to fix those issues and retest. Don’t skimp on testing…hackers are not forgiving and just like in dodge ball, there are no “do-overs”.

Maintaining

Once you have tested everything and are assured that your organization is where they need to be, you now need to create and maintain a testing program. Don’t try creating a maintenance program prior to everything being tested, as you will surely be making changes to the maintenance program, making are previous efforts null. Your maintenance program needs to have firm dates / times set for scheduled maintenance. You need to have multiple maintenance programs set up such as:

  • Patch management
  • Password management
  • Network account management
  • System management
  • Applications management
  • Operating system management
  • Security administration etc

By setting up multiple maintenance programs you are able to create “silo’s” for each area and assign personnel who are responsible for each of these areas. This allows for a better view should there be a failure in any of these areas…and makes it easier to see where the failure occurred and to fix the area faster.

Worth Considering

There are a few tricks that you can implement on your network that will make a hacker think twice about trying anything. The more difficult you make it for the hacker to attack, the more likely it is that they will go somewhere else to attack. As someone who has spent the better part of the past quarter of a century protecting companies against attackers, I have listed a few neat tricks you can implement:

Honey Pots

A honey pot is a trap set to detect, deflect, or in some manner counteract attempts at unauthorized use of information systems. Generally it consists of a computer, data, or a network site that appears to be part of a network, but is actually isolated, (un)protected, and monitored, and which seems to contain information or a resource of value to attackers. These honey pots can be used to track and in some cases trap and report a hacker.

Trace Routing

Having the attacker’s IP is all well and good, but what can you do with it? The answer is, a lot more! It’s not enough to have the address, you also need to know where the attacker’s connections are coming from. You may have used automated trace routing tools before, but do you know how they work?

Go back to MSDOS and type tracert *type IP address/hostname here*

Now, what happens is, the Trace route will show you all the computers in between you and the target machine, including blockages, firewalls etc. More often than not, the hostname address listed before the final one will belong to the hacker’s ISP company. It’ll either say who the ISP is somewhere in there, or else you run a second trace on the new IP/hostname address to see who the ISP Company in question is.

Reverse DNS Query

This is probably the most effective way of running a trace on somebody. If ever you’re in a chat room and you see someone saying that they’ve “hacked into a satellite orbiting the Earth, and are taking pictures of your house right now”, ignore them because that’s just bad movie nonsense. THIS method is the way to go, with regard to finding out what country (even maybe what state/city etc.) someone resides, although it’s actually almost impossible to find an EXACT geographical location without actually breaking into your ISP’s head office and running off with the safe.

To run an rDNS query, simply go back to MS-DOS and type netstat and hit return. Any active connections will resolve to hostnames rather than a numerical format.

DNS stands for Domain Name Server. These are machines connected to the Internet whose job it is to keep track of the IP Addresses and Domain Names of other machines. When called upon, they take the ASCII Domain Name and convert it to the relevant numeric IP Address. A DNS search translates a hostname into an IP address….which is why we can enter “www.hotmail.com” and get the website to come up, instead of having to actually remember Hotmail’s IP address and enter that instead.

Well, reverse DNS, of course, translates the IP address into a hostname (i.e., in letters and words instead of numbers, because sometimes the hacker will employ various methods to stop netstat from picking up a correct hostname).

While we’ve given you a very high level look at what needs to be done to better protect yourself from a hack attack, we believe it represents the best place to start in understanding what you need to do.

James Holler is founder of Abidance Consulting.

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Part I: Protect Your Data and Your Company From an Internal or External “Hack-Attack”

James Holler, Founder, Abidance Consulting

Part 1 of a 2-part series

First, let me start with the bad news: There is no absolute way to prevent an internal or external hack-attack. With that said, there are some things that you can do that will make it so difficult to pull off a hack-attack, that the perpetrator will most likely want to go somewhere else and try their attack.

Now, there is an old saying, “cleanliness is next to Godliness.” I am sure you have all heard that line at some time in your life. This saying holds true in the security world. If your network is in total shambles (DAT files not updated, Service Packs are so far behind your need an abacus to determine how many versions behind you are, etc.) and your Intrusion Detection System (IDS) is monitored by humans only during business hours, then you have a “dirty” network that needs to either be cleaned, or as my mom used to tell me…let’s just burn your room and start over, it will be easier that way. If your network/server room looks as if a spaghetti factory has blown up, get it cleaned up by rewiring it using tags on each line so you know where each of the cables is assigned.

The first thing you need to understand in preparing to get your network in top form is to not only determine what is wrong with it, but to also be open to criticism from experts. Put away the ego (one of the top reasons why networks are in shambles to begin with) so that you can listen and learn from your internal experts or external consultants – you hired them, now listen to them.

In Part 1, we’ll look at network discovery issues, vulnerability assessments, and discuss ways to fix some of these challenges.

Network Discovery

Before you can determine what’s wrong with your network, you must first know what your network looks like. You will want to conduct a thorough network discovery since you are going to need to know not only what devices are on your network, but also where they are. Please don’t think that you are going to run a piece of software that will show you everything. If you have a wireless or dial-up modem hanging off of your network and the power button is off, you may never discover it. You may need to do a physical inspection of your entire facility…look up in the ceiling…those pesky tiles can support the weight of a modem and even an old sandwich from 4 years ago. I personally use an iPaq handheld device that is capable of “sniffing” out these modems, even when they are turned off. Now that you have a true and correct picture of your network, you will need to conduct a vulnerability assessment to determine what areas are weak and are in need of attention.

Vulnerability Assessment

To ensure that there are no “cover-ups” by your staff, it is recommended that you have an outside consulting firm come in and conduct the assessment for you. Depending on the size of your organization, the fee’s for this could be $15k to $30k or more. The final report to be delivered should be comprehensive in nature. Be sure to ask for sample reports prior to awarding a contract or project to anyone. There are areas that must be looked at closely. Make sure whoever you assign the project to gives you a list of the services they are going to run. My only word of caution here is that you do not allow a penetration attack be made against your Primary Domain Controller (PDC). Once the assessment is completed, make sure that you not only address the issues, but fix the issues.

Fixing The Issues

When you do get the final report, there are going to be a lot of errors that need to be fixed. Don’t worry; the “bark” of the report is much worse than the “bite”. Depending on how bad your network was when the assessment was conducted, you may have a few pages of issues to as much as a thousand pages of issues – one assessment we did a few years back yielded almost 7,000 pages (a government agency…need I say more). When you are reading your final report, one of the first questions you need to ask yourself is, “Where do I begin”? Not to worry, your security staff/consultants should prioritize what needs to be done and at what point in the project does it need to be done. The point at which a certain task is completed is very important since everything has a logical order of semblance to it…you wouldn’t put the seats in a car before you laid down the carpet. Your staff and/or consultants should know this and be able to build out a project plan with a scope of work, keeping you (the stakeholder) in the loop at all times. Never be afraid to ask questions or challenge something if you feel it isn’t the right thing to do or you don’t understand why something is or isn’t being done.

To save time and money, you have to look at all of the different compliance issues you have to deal with (NERC, EPA, OSHA etc) and cross-walk your efforts to all of these compliance requirements. Doing this will ultimately save yourself time and money by not overlapping efforts.

Next time, we’ll look at testing, maintaining, and some other important issues that merit your attention.

James Holler is founder of Abidance Consulting.

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Hackers Up the Ante in Attack on Electronic Data in Power Plants and Other Facilities

James Holler, Founder, Abidance Consulting

According to the Wall Street Journal (WSJ), computer hackers have designed a virus that targets the industrial control systems, to include power plants, built by German engineering giant Siemens AG. The virus apparently activates a kind of malicious software that analysts say represents a growing corporate-espionage threat. This type of threat has been talked about for years — and it is now a reality.

The virus, Stuxnet, is spread by USB devices plugged into the physically unsecured USB ports on the machine(s) hosting the SCADA systems used by power plants and other types of facilities. The virus is programmed to steal data from computer systems that are used to monitor power plants built for anything from manufacturing to power generation to water treatment.

Researchers analyzing the virus say that they are now seeing several thousand infection attempts daily, though the virus is only activated if it lands on a computer running the Siemens systems software. Analysts warn that the attack on the Siemens’s systems marks an escalation in hackers’ efforts to use viruses for industrial espionage or sabotage purposes. This attack will surely make the NERC CIP regulations become even tighter more quickly than before this story broke.

Smaller, more isolated virus attacks have been attempted before on SCADA systems, but this is the first such infection where a virus is searching specifically for SCADA systems to attack on such a large-scale basis. The worry among security analysts should be that such viruses will, at some point, be used by criminal organizations or even terror groups to sabotage power plants.

The Stuxnet virus specifically exploits an unpatched vulnerability in the Microsoft Windows operating system, allowing it to spread through all USB devices. Once the virus has infected the Siemens system, it uses default passwords that are hard-coded into the Siemens software to upload false control-system data to a remote server. In an advisory that Siemens posted on its website, the company said Microsoft was working on a patch to fix the vulnerability at the USB interface. In its own website advisory, Microsoft has provided a workaround fix to offer some additional protection until a patch, or update, is ready.

Siemens said it expects to approve the updated virus scanners this week and also plans to provide customers with a diagnostic tool to check if their systems have been infected. In the meantime, the company’s website advisory urges customers not to use any USB storage sticks.

Siemens, Microsoft and other security analysts haven’t determined where the virus originated. Many of the infection attempts have originated from India, Indonesia and Iran. The virus likely was created in Asia, given the pattern of attacks and technology used.

James Holler is founder of Abidance Consulting.

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Savvy Compliance Strategy Part III: How to Track Problems

Sal Lucido, VP Enterprise Solutions, AssurX

Sal Lucido, VP Enterprise Solutions, AssurX

In previous series of articles Part I and Part II, we discussed the benefits of using a closed-loop process for managing regulatory compliance (pictured below). I also showed how setting up Key Performance Indicators (KPIs) that monitor performance to goals is a good way to Check that processes are working properly, thus reducing the need to perform manual audits of a given operation.

The Circle of Compliance

The Circle of Compliance

Let’s now take a closer look at the Track Problems step. The primary goal of this step is to collect and analyze data related to operational problems. This is a vital prerequisite for the next step in the process: Improve. Remember our overall goal is to systematically and continuously improve regulatory compliance. So let’s first take a look at collecting data.

Collecting data about operational problems sounds like an easy task, but it turns out to be anything but. First of all, there is a cultural stigma associated with anything that is labeled as a problem. This is because, where there is a problem, there is blame. And where there is blame, there are consequences. Given the fact that we are talking about consequences associated with someone’s livelihood, this is not something to take lightly. Therefore it is important to set a “tone from the top” that let’s employees know that the data will be used to improve operational processes and not punish employees. It is also helpful to ask employees to suggest improvement ideas. I’ve even seen some companies acknowledge and reward employees for suggestions that result in positive actions.  These are all good ways to encourage problem reporting. You want to tip the scale in favor of logging problems as shown in the illustration.

Logging Problems

Logging Problems

The next question is, “What data should we be collecting?” Let me start by pointing out that some data is better than no data. Waiting to create the perfect system will result in the loss of valuable information that could have alerted you to looming problems. So at the very least, start collecting data any way that you can.

I have seen hundreds of problem tracking forms spanning many processes and many industries. I’ve created product issue forms, process problem forms, out of spec forms, suggestions forms for industries regulated by the FDA, NERC and the SEC. I’ve summarized four design tips in the next illustration.

The Four S's: Problem Tracking Form Design Tips

The Four S's: Problem Tracking Form Design Tips

Now that you are collecting problem data, what should you do with that data? The high level steps for processing issues are: Identification, Investigation, Immediate Actions, Analysis and Planning for Further Action.

Problem Processing Flowchart

Problem Processing Flowchart

This is a summary of what each of these steps involves:

Identify: Collect problem data from all sources. Route these to someone that can determine immediate actions and investigate the problem.

Investigate: Look into the problem beyond the initial problem report. Look for trends from other sources (employees, vendors, customer) and from similar product and problems.

Immediate Actions: This step may be performed in parallel with or before the Investigate step. Determine if there are any immediate actions that need to be taken to contain the problem. While you are looking for root causes you don’t want the problem to grow or continue to do damage.

Root Cause Analysis: This is different from the initial investigate step in that you now are trying to determine what actually caused the problem. During the investigation you may determine that the problem was a result of operator error. But the root cause analysis may reveal that the operating procedure is unclear and is in fact the root cause of the problem.

Plans for Further Action: Once you have established the root cause you can take actions to Improve operations. In this step you would plan out what those improvement actions will entail, who will implement them, and how long they will take to enact. Typically this Corrective Action project requires management approval to allocate the required resources.

One benefit of this process is that a single Corrective Action project can address multiple problems. See the following illustration.

Investigation Funnel

Investigation Funnel

The next step is to Improve operations through implementing the corrective action project. We will take look at that step in the next article.

Read Part IV.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him at http://twitter.com/ComplianceTips

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