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.

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.

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.

Lora Keena, Vice President of QA/RA, understood the importance of operating at the highest possible level of efficiency while not sacrificing safety, so she set out a goal to find an electronic solution to help establish real-time procedures that were easy to understand, train and update anywhere, anytime Oliver Medical personnel needed to do so.

She knew they had to move everything – forms, testing, and all quality systems – from paper to electronic. “Our old way was time consuming and cumbersome…we were faxing hard copies back and forth and it took forever,” Lora recalls.

There were four key requirements for a new electronic system:

• Reasonable price
• 21 CFR Part 11 compliance
• It had to meet their needs for document control
• Fast implementation

“We didn’t have 12 – 18 months implementation time. I didn’t want that kind of delay” said Keena.

Lora and her team narrowed down their search to four vendors and AssurX’s Software as a Service (SaaS) solution quickly rose to the top.

Read the entire story about Oliver Medical.