Built-in metrics, robust help files and an easy dashboard-centric user interface require minimal training to get up and running quickly.

AssurX One system consistently tracks, measures and demonstrates compliance for an array of NERC and regional standards and requirements, including annual policy reviews, to asset and cyber security management, and document control.

Included in the AssurX One program:

1. Best practices, pre-configured workflows (NERC gap analysis, self-certification schedules/calendars, document control, cyber security management), dashboards and metrics.
2. Hosted on a secure, OnDemand system with preloaded NERC and regional standards and automatic regulatory updates.
3. Web-based implementation and training. Tutorials provided for each workflow.
4. Exclusive industry focused compliance Webinars and workshops.

For more information, download the detailed brochure (PDF):

Trey Kirkpatrick, Vice President, Energy and Utilities Compliance, AssurX

AssurX is pleased to announce the appointment of Trey Kirkpatrick as Vice President, Energy and Utilities Compliance.  Prior to joining AssurX, Trey served as Manager, Compliance Implementation and Registration for the Northeast Power Coordinating Council (NPCC) where he was responsible for registering all entities that met the requirements of the NERC Statement of Registry Criteria. NPCC has over 305 companies registered that are responsible for over 600 functional responsibilities as owners, operators and users of the bulk-power system.

While at NPCC, Trey was chairman of the NPCC Compliance Committee (CC) reporting directly to the NPCC Board of Directors.  As chairman, he worked closely with NPCC staff and stakeholders to continuously improve the compliance monitoring and enforcement process at NPCC.  He was also chairman of the NERC and Regional Entities – Registration and Certification Working Group (RCWG) where he worked with the eight (8) regional entities and NERC on setting strategic priorities for registration and certification within North America.

Prior to NPCC, Trey served as Manager, Reliability Compliance at Northeast Utilities where he was the lead manager representing Northeast Utilities’ Operating Companies’ strategic and operational interests with the North American Electric Reliability Council (NERC). While at Northeast Utilities, he was in charge of oversight of all matters related to reliability rules, including rules development, internal compliance assessments, compliance reporting, compliance audits conducted by sanctioned regulatory authorities, and developed and maintained all necessary records demonstrating Northeast Utilities’ compliance on a system-wide basis.   Trey was also a representative on the NERC Compliance and Certification Committee (CCC), which is a stakeholder body working closely with NERC and Regional Entities.

Trey comes to AssurX with an extensive background in energy and utilities having spent the past 20 years in various engineering and compliance positions in the industry; including in nuclear power generations and transmission. He will contribute his leadership skills in expanding AssurX’s compliance products and services in North America’s energy and utilities industry.

You can follow Trey on Twitter: http://twitter.com/CATSWebER

Santa Clara, CA, Morgan Hill, CA – Expandable Software, Inc., a developer of ERP software and AssurX, Inc., provider of quality management and regulatory compliance solutions announced the launch of joint products and a partnership that brings critical regulatory compliance solutions to medical device and life science manufacturers. This enterprise-level global solution and partnership has already proven fruitful with a first joint medical device customer, ReVision Optics (RVO).

“As RVO prepares for expanded Vue+ commercialization, it is important that our quality systems grow and expand as we navigate through regulatory compliance processes,” said Ali Dahi, ReVision Optics’ V.P. Operations. “As we drive our business priorities in preparation for meeting these requirements, our choice of Expandable’s core ERP with integrated extension to CATSWeb help us incrementally bring functionality on line as our business dictates the need.”

The strategic partnership with AssurX reinforces Expandable’s commitment to providing a complete integrated solution for manufacturers competing in the life sciences industry.  Integration with CATSWeb delivers Expandable customers a powerful quality management solution that provides enterprise-wide visibility of quality issues and processes helping medical technology manufacturers meet the stringent requirements of the FDA and other governing bodies.

“What we’re offering Expandable customers is an extremely attractive entry point to a very robust quality management solution,” said Bob Swedroe, CEO of Expandable Software, Inc. “We’ve found that growing medical technology manufacturers have a distinct need for integrated quality management but often delay or forego the investment because of the typical high cost of commitment. Our partnership with AssurX is aimed at providing customers with a tier-one quality solution, integrated with Expandable ERP, that can be deployed by companies that are anywhere from pre-production to the high growth phase of their expansion cycle.

“Connecting the AssurX quality and compliance management system to the Expandable ERP system provides a complete solution for manufacturers, especially life science companies. This allows manufacturers already using the Expandable ERP system to realize the benefits of integrated quality and compliance process functionality. It also extends four pre-configured, 21 CFR Part 11 compliant processes to Expandable’s ERP customers: customer complaint handling, nonconformance tracking, supplier quality and corrective and preventive action (CAPA) management. We are thrilled that Expandable selected AssurX to provide this integrated functionality,” added Sal Lucido, Vice President, Enterprise Solutions, AssurX.

“Our product strategy is to provide a completely integrated enterprise-level solution that medical technology manufacturers can use to establish sound business practices early in their growth cycle,” said Dennis Payton, Expandable’s director of product marketing. “Our relationship with AssurX allows us to provide comprehensive solutions that meet the very demanding long-term needs of medical technology manufacturers at an investment level that is affordable for growing companies.”

About Revision Optics

ReVision Optics, Inc., (RVO) is a privately held corporation headquartered in Lake Forrest, California. The company’s main focus is the research and development of minimally invasive implantable devices for the restoration of reading vision.

ReVision Optics’ current product portfolio includes the Vue+ corneal microlens. Vue+ is a tiny contact lens-like device that is placed just beneath the surface of the eye. The lens is made from a proprietary, optically clear, biocompatible hydrogel that is similar in nature to the natural cornea. The lens is designed to slightly change the shape of the corneal curvature to improve near or reading vision, decreasing the need for reading glasses.

The company is actively pursuing regulatory approvals and market opportunities for the Vue+ worldwide. The Vue+ has received CE mark and is approved for sale in Europe. For more information, please visit www.revisionoptics.com.

*Caution, the Vue+ is an Investigational Device and is limited by United States federal law to investigational use only.

About AssurX

AssurX, Inc., provides highly regulated organizations with enterprise quality management and compliance solutions. With a choice of OnDemand (SaaS) or OnPremise (licensed) software delivery options, AssurX’s flexible, all-in-one system automates quality and compliance processes so issues can be centrally managed. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise. More information is available at www.assurx.com.

About Expandable

Expandable Software, Inc. develops, markets and supports an enterprise resource planning (ERP) software suite designed to help executives and managers of fast-growing companies maximize business performance by maintaining visibility and control of manufacturing operations. Expandable’s fully integrated accounting, engineering and manufacturing modules provide a solid back office foundation while CRM, e-business, and supply chain functions deliver front office tools to manage business relationships, and streamline transactions.

The Expandable system is targeted to medical device, high tech and other manufacturers who need a dependable business foundation that will support their growth all the way to the billion dollar mark.

Expandable is located in California’s Silicon Valley.  More information is available at www.expandable.com.

NERC

“It’s pretty good,” says Paul J. Fricke, CQMgr, CQA Quality Manager/Project Manager at AssurX, Inc. “It sets up a direct and rapid communication to registered entities on when to send alerts and to have the mechanism to do it effectively.”

When registered entities receive an alert, they’ll then log into a secure site to receive the full update details.

There are three levels of alerts, in rising levels of seriousness:

• Level 1 – Advisory – information only
• Level 2 – Recommendations to Industry – usually requires that a questionnaire be completed and submitted back to NERC
• Level 3 – Essential Action – these require information back from the registered entity – highest level of alert, seriousness

NERC also set up a fairly straightforward means of labeling how carefully to protect information contained in an alert:

• Green – Public
• Yellow – Private
• Red – Sensitive
• Black – Confidential

NERC also just released its report for 2009 which addresses a year of transition (changes at the top) and a broader kind of transition: It’s “one of focus as we enter our third full year as the entity responsible for developing and enforcing compliance with mandatory reliability standards,” says Gerry Cauley, NERC’s new President and CEO.

Cauley’s ambitious vision is “to broaden our focus from a compliance organization to a learning organization, one that fosters learning and facilitates growth, both within our organization and across the industry.”

Given all that NERC is trying to do – some well, some maybe not so well – we’ll keep you posted on how they deliver on some tough promises in 2010.

See also:

NERC Unveils Improved Standards Development Process

The Top 10 FERC Enforceable Standards in 2009

That’s what police usually say when a crowd gathers to watch something new, unusual or just plain interesting.

Reminds me of an article I recently ran across declaring that Software as a Service (SaaS) technology was indeed configurable.  The jist of it was that NetSuite CEO Zach Nelson was attempting to shatter some of the common misperceptions about SaaS during his keynote address at a company’s partner conference in San Francisco last week.

The WebCPA article covering Zach’s speech went on, “Addressing claims that most SaaS solutions are not customizable, Nelson claimed that there are currently 6,600 users utilizing NetSuite’s enterprise resource planning functions, the majority of which are customizable features.”

Extra! Extra! Read all about it: SaaS is configurable, says Zach.  And we’ve blogged about this before, too.

But is this news to anyone?

Apparently it is in some circles. So why has SaaS gotten a bad rap as inflexible?

Blame it on the early days of SaaS, when some providers offered more rigid, “pigeon-holed” solutions, says AssurX Operations Manager Karl Kleinkauf, who’s been in this business nearly twenty years. “In the old days there was something of a ‘take it or leave it’ attitude,” Karl adds.

But that’s all changed in recent years, Karl notes. For starters, the technology has improved and ample bandwidth is more widely available today. Both factors help make SaaS more configurable. But consumer demand also helped make it happen, Karl notes.

In fact, as his own customers get more adept using SaaS for regulatory compliance, they often see other uses for it. “I’ve helped many use our SaaS system for document control and customer complaint handling after they’ve gotten comfortable with it on the compliance side,” Karl says.

So let’s recap: SaaS is flexible, multi-faceted and configurable.

Remember, you didn’t read it here first.

REGISTER: https://www2.gotomeeting.com/register/554360930

WHO SHOULD ATTEND: All AssurX Energy/Utility Customers

AGENDA:

How to Manage NERC CIP Workflows & Documentation
NERC CIP Compliance Management – CIP-002 thru CIP-009 reached the Auditably Compliant stage July 1st, 2009. In this talk we will take a look at best practices for managing CIP workflows including configuration change management and process/plan review workflows.

How to Manage a NERC Compliance Framework
Part of a NERC audit includes submitting information about how your internal documentation (i.e. procedures, policies, etc.) relates to each applicable requirement. This presentation will demonstrate how CATSWeb ER can be used to establish this compliance framework.

NERC Standard Update Service
View how the NERC Standard Update Service is used to import new NERC standards and file attachments into your CATSWeb ER system.

Self Certification
Using the new CATSWeb 16Q Service Pack rules engine, view how your self-certification preparation process can be automated to create and assign all Gap Analysis records and monitor when all Gaps have been completed.

Using CATSWeb for PRC-005-1 Compliance
Demonstration of CATSWeb configured as a standalone system as well as an integration hub with various Work Order Management, ERP and Test Systems assuring that assets which effect the BES are in PRC-005-1 compliance.

Taking your CATSWeb ER system beyond your expectations
An opportunity to learn how companies use CATSWeb ER to steamline the management of documents, assets, approvals, certifications, testing, exceptions, etc.

Sessions will last anywhere from 20 – 45 minutes each and will be followed by a 5 – 10 minute Q&A, as well as a midway break. This four hour event will be recorded and available for replay shortly afterwards. Presentations will be available for download immediately following the event.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

UPDATE 2: (July 2010): FDA: eMDR Guidance Probably Won’t Happen This Summer.

UPDATE 1: (June 2010): Please see our updated blog on the new timeline here.

Well, they finally did it.

After more delays and internal intrigue than your typical Hollywood Blockbuster, the FDA today unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports.

It’s going to save time (paper submissions take up to two weeks to process at FDA HQ) and money for both industry and the agency.

But will device firms be ready?

A telling stat that came out of today’s press teleconference announcing the draft guidance: While about 80% of the nearly 500,000 submissions CDER gets already come in electronically, on the CDRH device side it’s only about 15%.

“We have some work to do” on the device side, David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH), observed mildly at today’s press conference.

Why are pharma firms so far ahead of device firms here? It’s odd because in many ways device firms are viewed as more tech savvy and more of the early adopter type. But the fact that pharma companies are generally much bigger, with much deeper pockets, probably explains some of why they have such a big electronic jump on their device brethren.

Device companies have also complained that the FDA hadn’t made its eMDR expectations clear. But that excuse won’t really hold now that the agency has issued a pretty straightforward guidance.

Industry has 90 days to comment on the draft guidance. After that, the agency will take a few months maximum to digest and perhaps take advice from those comments. Then they’ll issue a final rule that will mandate esubmissions for mandatory reporting (such as adverse events) a year from then.

So, mark your calendar for sometime around February 2011 for a mandate from the agency.

Will device firms be ready? There’s no excuse not to get with the program now.

Download the PDF version of the draft guidance here.

More information about AssurX’s eMDR solution here.

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.

Registration for this event is now open — please CLICK HERE here to learn more and register today!

This year AssurX will host its first annual Life Sciences Special Interest Group (SIG) meeting in Las Vegas, NV. This industry-specific event will start with a kickoff dinner, followed by two days of training sessions, best practices, customer case studies and more. Instead of holding an annual general user conference, we’ve listened to our customers and decided to hold industry specific events with our most recent one for our energy industry customers.

Don’t miss this great opportunity to:

• Learn from your peers
• Talk with experts about the latest industry developments
• Spend one on one time in the computer lab with AssurX’s professional services team
• Attend break out sessions
• See new product features
• Listen to customer case studies
• Participate in roundtable Q&As
• Network!

Tentative schedule:

• October 4, 2009 – Kickoff dinner and networking event
• October 5 – 6, 2009 – Case studies, training opportunities, all-day sessions, computer lab time.

Stay tuned for updates, final agenda and registration information.

In our open forum we learned about how everyone is using the product to manage compliance to the NERC Standards and much more. Presentations on CIP Compliance, Compliance Framework and a customer presentation were loaded with important, useful information. I want to thank RRI Energy for a very informative presentation on their NERC compliance process: recurring evidentiary documentation/
gap analysis process.

I also want to thank our customers and partners who participated in this great event. We look forward to the next one!