The concept of implementing SaaS is moving ahead quickly, especially in the medical device arena. Perhaps that shouldn’t be surprising; most industry experts say that device firms tend to be a bit more innovative when it comes to embracing new technologies.

That may be why Angiotech made the decision to go with AssurX’s OnDemand (SaaS) model as opposed to on-premise implementation for their global complaint handling system. Angiotech is a global specialty pharmaceutical and medical device company that discovers, develops, and markets innovative technologies and medical products primarily for local diseases or for complications associated with medical device implants, surgical interventions and acute injury.

AssurX’s CATSWeb system is already rolled out across four facilities – three in the US and one in Puerto Rico – with Europe expected by the end of 2009.

Larry Murphy, Senior Manager, Corporate Quality, was part of the team that made the decision to go with the SaaS model because they needed to get up and running quicker.

“We got the blessing of the IT group after they reviewed the AssurX system and were able to get answers quickly about the level of security and support,” Murphy said. “As far as the users are concerned, they really like having everything centralized, including the reporting capabilities. We have significantly improved our efficiency and productivity,” added Murphy.

Prior to implementing an automated complaint handling system, various divisions of Angiotech were using either paper-based systems or homegrown Access database applications. Now the company-wide system using CATSWeb allows them to process complaints in a more structured and standardized manner that provides a much higher level of quality of information as well as the ability to track progress using metrics and dashboards.

Future plans include expansion of the current process and perhaps implementing electronic medical device reporting (eMDR) somewhere down the line.

During 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.

How 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.

More 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.

The Royal Bank of Scotland (RBS Group) is one of the top 10 banking groups in the US and a principal supplier of corporate finance and debt capital markets services, with retail banking franchises stretching from New England to the Midwest.

In 2005, Juel McQueen, Assistant Vice President, Compliance, and her team in quality assurance needed a solution to track all corrective actions, periodic reviews and verification documents. Since resources for IT were already stretched, they decided to pursue a solution that was available as SaaS (Software as a service). After researching numerous vendors, Ms. McQueen and her team selected CATSWeb OnDemand with the blessing of their IT department because it suited their needs for security, functionality and versatility. CATSWeb is hosted at a SAS 70 Type II certified facility.

Prior to CATSWeb, the QA department was using Microsoft Word and Excel and routing files by email to solve their corrective actions and sign off on documents. Some of these attachments ended up being accidentally deleted or overlooked.  Now, instead of relying on file attachments in email, all users log into the CATSWeb system, view the tasks and documents assigned to them, and electronically sign off on them in a much more accurate and timely manner.

“AssurX helped me get started on the system with initial training, and now I do the necessary configuration changes myself,” said McQueen.

In addition to providing a centralized system for users, CATSWeb also generates executive reports for test results, findings and corrective actions.