May 17, 2012

Why PG&E selected CATSWeb ER for Ethics, QA and Compliance Management

pgelogoDuring the vendor search phase that started approximately a year prior to final selection, PG&E required three basic criteria: Vendor had to have a real product (no vaporware and no custom software), must have sold the product to at least one major utility, and had to have a proven GRC engine. One other criterion was that the system had to be on-premise.

After reducing the vendor count to three, all of them were invited to demonstrate the system using tightly scripted demo requirements created by PG&E.  In the end, PG&E said AssurX stood out for several reasons:

  • The live demonstration presented by AssurX was “flawless” according to a member on the selection committee
  • AssurX scored the highest in the requirements matrix – functionality was at the top of the list
  • PG&E was extremely impressed with the whole sales process and support from AssurX – “they were open and honest from day one and they were able to demonstrate exactly what we were looking for”

In fact, the live demonstration of the system went so smoothly that PG&E commented how “deeply impressed” they were. “That looked way too easy,” said one attendee.  PG&E will be using the system for compliance, ethics and commitment tracking across the country and for internal auditing, NERC compliance, gas compliance and quality assurance.

Pacific Gas and Electric Company, incorporated in California in 1905, are one of the largest combination natural gas and electric utilities in the United States with approximately 20,000 employees and revenues of almost $15 billion.

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Why AssurX OnDemand Has Maintained 100% Uptime Two Years Running

100% UptimeHow does one achieve five 9′s (99.999%) uptime or better in today’s crazy IT world?  Easy.  Have backups for your backups and have at least two of everything.

Okay, so maybe it’s easier said than done and perhaps that is an egregious oversimplification. The bottom line, however, is basically that’s how AssurX has achieved not five 9′s but a perfect 100% uptime for CATSWeb OnDemand systems for two years running.

We have multiple redundancies in all our critical infrastructure systems: at least two of everything.  We have everything from multiple pipes to the Internet to multiple fire suppression systems.  There are multiples of all server types; web servers, application servers, database servers, backup servers. There are multiples of all components of the servers; multiple drives in RAID arrays, multiple network cards, multiple power supplies, multiple CPUs.   There are redundant monitoring systems, monitoring internally and externally the availability of CATSWeb and we are notified immediately when something is wrong.  Fortunately (knock on wood), we’ve yet to experience this scenario outside of testing.

Our data center is the same way.  There are redundant heating and cooling systems, redundant fire suppression systems, redundant UPS systems, redundant generators and everything is in “hot standby” mode, meaning if one fails, the other takes over without missing a beat.   The network employs at least three major telecom providers for separate and redundant backbones to the Internet.

To someone unfamiliar with the true meaning of “mission critical”, all this sounds like overkill. Doesn’t having two (or more) of everything make life more difficult?  Simple answer is, yes, life is more complicated with two of everything.  There are the requirements of extra space, extra maintenance, extra power consumption, extra time for install/management/decommission of software packages and extra man hours spent working on all these redundant systems.  Does it make financial sense?  Absolutely!  Just the same as one has homeowner’s insurance, car insurance, health insurance or life insurance, what redundancy means to an IT department is data and connectivity insurance.  For hosted systems like CATSWeb OnDemand, it means happy customers who always get to their data, day or night.  For IT guys like me it means peaceful, easy sleep and less hair loss.

At the end of the day, the simple fact is that AssurX has achieved something truly difficult in the IT world; 100% uptime, two years running.  This is something major players, like Yahoo, eBay, Google, Amazon and many others cannot claim.  We are proud of our commitment to hosting CATSWeb for our customers and will continue to implement new and better ways to achieve and maintain the best possible uptime numbers and availability as we forge ahead.

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Keystone Dental Takes Fixing Smiles Very Seriously

keystonelogoMore than 30 million Americans are missing some of their teeth in one or both jaws, and with a growing aging population, that’s estimated to grow substantially. According to the American Academy of Implant Dentistry, an estimated two in three Americans have one or more missing teeth, due to the increase in periodontal disease as the population ages.

Three million people have dental implants and that number is growing by 500,000 per year with an estimated market for implants to reach $1.3 billion by 2010.  Dental implants are permanent fixtures of titanium posts anchored in the jawbone and topped with a replacement tooth. The technology was initially developed in Europe over 30 years ago and the success rate is remarkably high: 97 percent success rate in lower implants and 91% success rate in the upper implants.

Keystone Dental, based in Burlington, MA, was founded in March 2006, and aspires to build a market leading global brand recognized within the dental community for its integrity, trust and commitment to improving the standard of care for patients and their quality of life.

Since then, they have rapidly grown into a diversely skilled, fast-moving team of professionals committed to providing excellent customer service and producing high-quality products and services.

Keystone’s business plan called for an electronic quality management system to be implemented as soon as possible. Being an extraordinarily high volume medical device manufacturer, Keystone’s new system would have to handle an equally large volume of electronic records per year.

According to Richard Jancsy, Manager of Quality Systems, “A critical success factor for us is to effectively and efficiently manage a significant volume of regulatory documentation; in a rigorous and compliant manner…you need a reliable and highly configurable system to meet that challenge.  That’s why we selected CATSWeb.”

Instead of using a manual, paper-based system that tediously captures data, the new electronic system has streamlined the process; it’s focused on capturing the essential and actionable information quickly.  The implementation activity allowed Keystone to critically re-evaluate their current manual complaint handling system and design a robust solution by leveraging CATSWeb’s flexible capability.

“CATSWeb can mirror the process in a way that we get to choose, and not the other way around,” added Jancsy. Keystone will integrate the CATSWeb quality system with Salesforce.com and their IFS ERP.  The first process rolling out is complaint handling and then CAPA, audits, training and change control during 2009.

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How Secure is Your Data in a SaaS Environment?

security1In the IT world, there is ever that security pendulum that either seems to move toward ease of use or toward restrictive control.  Users typically tend towards the “ease of use” end of the spectrum because who wants to remember yet another password?  And who wants to install complicated VPN software or jump through extra authentication hoops? Conversely, IT folks (like me) tend to believe in restrictive control, in complicated passwords as possible, extra authentication hoops and logging everything that happens over an established connection.

With the advent of SaaS (Software as a Service), security becomes all the more critical in terms of both the user of the service and the administrator of the environment providing that service.  The beautiful thing about SaaS offerings like CATSWeb is that they are completely web based through HTML.  This makes life much easier for all parties.  From the user side, CATSWeb requires no special VPN software, nothing downloaded to the client computer and no local certificate store to verify a user’s identity  only  a web address and a password.  From the IT standpoint, all machines involved in providing CATSWeb SaaS are completely locked down to two ports of traffic; an IT dream come true.  Users will either be coming into a hosted CATSWeb environment via HTTP (port 80) or HTTPS (port 443). For securing a server to the world, only having to deal with two ports is about as simple a scenario as exists in the IT industry.

Because CATSWeb traffic is only on two ports, our servers are locked down completely, with those two ports being monitored constantly through the firewall, protected by live scanning anti-virus solutions and safeguarded by managed IDS (Intrusion Detection) systems.  Add to that all web traffic is logged from start to finish and you’ve got as bulletproof a server system as can be found.  And then we get to CATSWeb itself.

Within CATSWeb, AssurX has included additional security tools to ensure that your data is safe.  First, each customer company has their own unique, individual database not shared by anyone else. If a customer chooses to require SSL for accessing their CATSWeb database, this ensures that all traffic to and from that database is encrypted.  System access is automatically logged for easy review, including the IP address from where the traffic originated.

The rest we leave up to users.   I guess that’s where CATSWeb SaaS becomes a two-pendulum system. The “server security pendulum” we’ve chosen to swing as far toward restrictive control as possible.  The “user access pendulum” we leave to the users of CATSWeb.  An administrator in a CATSWeb system can set their own requirements for passwords for their users, establish their own session parameters such as session length and inactivity timeouts and much, much more.  This will allow any given SaaS CATSWeb system to have security anywhere along the user access pendulum, from easy to restrictive, based on what your requirements are.

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A Rose by any Other Name Would Smell as Sweet

roseblackAnd so it is with Information Technology.  No one knows for sure what it was originally called but it seems to have origins defined by its first name…or was its name defined by the origins?  In the mid-90′s, when it was more an idea than a practice, we called it simply “hosted software”. Many dismissed it as “future-talk” and speculation, thinking few would actually ever pay to “rent” software over the Internet. But those of us in the industry thought it was brilliant.  A “win-win”, if you will.  Software companies able to make continuous streams of income and consumer companies able to cut back IT costs and never have to worry about upgrades, hardware and the other nightmares of running a mission critical application.

In the late 90′s, it became known as ASP or “Application Service Provider” and the media had caught wind of something new.  To date, this was the most popular term coined and was the most widely used. There were over 20,000 mentions of ASP in the press in the year 2000. When we began offering CATSWeb OnDemand in 2000, we considered it an ASP offering and some of the internal (behind the scenes) components are still branded with the ASP nomenclature.  As ourselves users of ASP’s poster child Salesforce, we thought the model had great potential and it helped us tremendously when our IT department was in its adolescence.

Coined shortly after ASP around the early 2000′s, some in the industry heard the term SaaS or “Software as a Service”. By 2003 or so this term began to build popularity and momentum as the new buzzword for hosted software. In 2005 SaaS overtook ASP as the acronym of choice and in 2007 there was a peak of over 10,000 press mentions of SaaS.  The industry by-and-large still refers to hosted applications as SaaS. We consider CATSWeb OnDemand a SaaS application and refer to it as such currently.

Now there is a new buzzword on the horizon that is rapidly gaining popularity and serves to define the newest generation of hosted applications: “cloud-computing” or simply “cloud”.  Cloud is basically the same business model, the same pros and cons and the same major players, like Salesforce and WebEx among many others. Same old idea, shiny new name.  And if history is any indication, we’ll see “cloud” gain in popularity until it peaks and another new term is coined to define this industry niche.

I guess the bottom line in all of this is that AssurX has a strong, time-tested, customer-proven hosted offering in our CATSWeb OnDemand product.  And frankly, we don’t care whether it’s referred to as “hosted software”, ASP, SaaS, cloud computing or the next new thing, whatever that may be.  We still intend to offer our software for customer use over the Internet for as long as people want to use it that way.  We will always strive to better our offerings, our uptime, our security and our reputation in this hosted model and be frontrunners in providing the best features and reliability with the best dollar for dollar value in the industry.

“Hosted software by any other name, would still accomplish the same”.

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3P Partners Signs Alliance Agreement with AssurX

3plogo13P Partners, headquartered in Hilton Head Island, SC, and AssurX have signed an Alliance Agreement allowing 3P Partners to provide a more complete service offering to their clients by utilizing the Quality Management, Risk and Regulatory Compliance software that AssurX provides around the globe.

“There are several niche solutions and toolkit companies that only offer a fraction of the out of the box functionality provided by AssurX,” indicated Deb Shumar, President of 3P Partners.

3P Partners provides innovative approaches, services and solutions for improving operational and workplace performance. Their unique suite of methodologies and tools enriches what people do, the processes they utilize, and products they produce which are keys to creating the right results.

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How Secure is Your Data in a SaaS Environment?

security1In the IT world, there is ever that security pendulum that either seems to move toward ease of use or toward restrictive control.  Users typically tend towards the “ease of use” end of the spectrum because who wants to remember yet another password?  And who wants to install complicated VPN software or jump through extra authentication hoops? Conversely, IT folks (like me) tend to believe in restrictive control, in complicated passwords as possible, extra authentication hoops and logging everything that happens over an established connection.

With the advent of SaaS (Software as a Service), security becomes all the more critical in terms of both the user of the service and the administrator of the environment providing that service.  The beautiful thing about SaaS offerings like CATSWeb is that they are completely web based through HTML.  This makes life much easier for all parties.  From the user side, CATSWeb requires no special VPN software, nothing downloaded to the client computer and no local certificate store to verify a user’s identity ­ only  a web address and a password.  From the IT standpoint, all machines involved in providing CATSWeb SaaS are completely locked down to two ports of traffic; an IT dream come true.  Users will either be coming into a hosted CATSWeb environment via HTTP (port 80) or HTTPS (port 443). For securing a server to the world, only having to deal with two ports is about as simple a scenario as exists in the IT industry.

Because CATSWeb traffic is only on two ports, our servers are locked down completely, with those two ports being monitored constantly through the firewall, protected by live scanning anti-virus solutions and safeguarded by managed IDS (Intrusion Detection) systems.  Add to that all web traffic is logged from start to finish and you’ve got as bulletproof a server system as can be found.  And then we get to CATSWeb itself.

Within CATSWeb, AssurX has included additional security tools to ensure that your data is safe.  First, each customer company has their own unique, individual database not shared by anyone else. If a customer chooses to require SSL for accessing their CATSWeb database, this ensures that all traffic to and from that database is encrypted.  System access is automatically logged for easy review, including the IP address from where the traffic originated.

The rest we leave up to users.   I guess that’s where CATSWeb SaaS becomes a two-pendulum system. The “server security pendulum” we’ve chosen to swing as far toward restrictive control as possible.  The “user access pendulum” we leave to the users of CATSWeb.  An administrator in a CATSWeb system can set their own requirements for passwords for their users, establish their own session parameters such as session length and inactivity timeouts and much, much more.  This will allow any given SaaS CATSWeb system to have security anywhere along the user access pendulum, from easy to restrictive, based on what your requirements are.

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Still No Definitive Timeline for eMDR Guidance Documents from the FDA

fda-logo

Back in October 2008, we posted this on our eMDR Updates page on our website:

No definitive release date for eMDR draft guidance documents from the FDA

In a recent Webcast, Indira Konduri of the FDA indicated that they were still working on the proposed rule making for electronic medical device reporting (eMDR). No specific time line has been released. However, she did hint that the time frame to implement (if mandated) would most likely be one year. As with any other proposed guidance, there will be an open public comment period.

Another FDA insider told us that the guidance documents would either be released at the end of this year, or early 2009. Original scheduled release date was 2Q of 2008. We’ll keep you posted as soon as we find out.

According to FDA officials we spoke to a couple of weeks ago, there is still no time-line for releasing the guidance documents to the industry. Apparently, everyone is waiting on the new administration’s leadership team for the FDA to be put in place before proceeding any further. However, considering the significant IT investments that the FDA committed to in 2008, mandating electronic medical device reporting is not a matter of if, but when. We’ll keep you posted.

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