Medical Device Tracking: Rapidly Changing USA and Worldwide Regulatory Environment

The September 2013 FDA Final Rule on UDIs for medical devices is now law!

So what does this mean for Medical Device industry?

It means that imminently, medical device manufacturers will have to upgrade their labeling and packaging systems along with their data management capabilities in order to stay compliant with incoming regulations and this is independent of creating systems to meet the demands of electronic regulatory reporting to the FDA and EMHA agencies.

How can Portford Solutions help me with my compliance needs?

On the whole, there was little concentrated information on the state of devices provided to the patient population by the industry. Simple marketing data such as what company makes what device; sales figures of each individual implants per medical device companies; or the number of procedures done for each implant each year are readily available. Key safety and efficacy information is not readily available to the companies, regulatory agencies and the communities they serve. Industry watchdogs are concerned that little information is gathered in any one place about the potential dangers and flaws of these devices, or the complications that occur due to their implantation procedure. Revised regulations are forthcoming, to be implemented over time.

At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection of problems with devices before they become an issue for the companies, regulatory agencies and the patient population.

So what exactly is the “Law” and what isn’t

There has been a great deal of confusion about what would be imposed by the Patient Protection and Affordable Care Act (PPACA) – (a.k.a., “Obamacare”) HR 32001 (1) passed in 2010. Think of the law as having many distinct parts. From the title alone you have the core components of Patient Protection (part of the law governing such things as increasing quality and access to information) and Affordable Care

At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection of problems with devices before they become an issue for the companies, regulatory agencies and the patient population.

Covering both labeling and the Global UDI (GUDID) database, manufacturers need to assess their current technical capabilities – both hardware and software – and work out how much they need to do in order to comply. Within the European market, the European Commission also announced their intention to follow suit, potentially as soon as this year (2014) (2). Compliance is to begin for some companies at the end of 2014 and all companies are to be fully compliant by 2020. Many Class I devices are expected to be exempt.

So what do I have to do?

The label of a device is to bear a unique identifier, unless an alternative location is specified by the U.S. Food and Drug Administration (FDA) or unless an exception is made for a particular device or group of devices.

The unique identifier to be able to identify the device through distribution and use.

The unique identifier to include the lot or serial number, if specified by FDA.

By the FDA adoption of the UDI system it is expected that the central requirement will create a common vocabulary for reporting and enhance electronic tracking abilities. Currently, analysis of adverse event reports is limited by the fact that the specific devices involved in an incident are often not known with the required degree of specificity. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is problematic. Reliable and consistent identification of medical devices would enable safety surveillance so that the FDA and manufacturers could better identify potential problems or device defects, and improve patient care.

The UDI is expected to improve patient safety (in part by helping to identify counterfeit products and by improving the ability of staff to distinguish between devices that are similar in appearance but serve different functions), facilitate and improve the recall process, and create efficiencies within the medical system.

In the most basic format, the UDI is a coded number registered with standards organizations, and would incorporate a variety of information, including (but not limited to) the manufacturer of the device, expiry dates, the make and model of the device, and any special attributes that the device may possess. In a medical sense, “device” refers to any product that is not pharmaceutical in nature, and while the FDA have been given approval to exempt some devices, FDA’s VP of the UDI Program, Jay Crowely (who was responsible for implementing the UDI requirements in the Act), has expressed an intent to apply the UDI to “everything until somebody gives us good reason not to”, (excluding devices which won’t need identification) (3).

So when do we have to act to meet compliance to the law?

Since the passing of the Act, there have been calls for the FDA to publish a timeline for the implementation of the UDI and that published timeline for the FDA website is presented herein:

FDA Compliance Dates for UDI Requirements

The table below outlines key compliance dates in the UDI final rule.

1 year after publication of the final rule (September 24, 2014)	The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300. A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014. Class III stand-alone software must provide its UDI as required by § 801.50(b).
2 years after publication of the final rule (September 24, 2015)	The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. § 801.45. Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b). Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
3 years after publication of the final rule (September 24, 2016)	Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45. The labels and packages of class II medical devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Class II stand-alone software must provide its UDI as required by § 801.50(b). Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
5 years after publication of the final rule (September 24, 2018)	A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45. The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18. Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule (September 24, 2020)	Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.

What isn’t the law? Compliance dates for all other provisions of the final rule. Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.

Well, what was in the specification of the original PPACA was the creation of a National Medical Device Registry (NMDR) but that was later dropped during the negotiations as being too intrusive at the time to be imposed upon the MedTech industry including biotech, pharma and medical devices industries and was dropped due to industry pressure related to adherence to the initial law. It is expected to be included in one of the next revisions of the PPACA. The task force for continued investigation already exists and they are working on proposals acceptable to industry, academia and regulatory professionals (4).

National Medical Device Registry (NMDR) – Rapidly Changing Regulatory Environment

Initially as proposed in HR 3200, a national medical device registry was to be established by the Department of Health and Human Services (HHS). Within the registry, devices would be listed by type, model and serial number, or some other unique identifier.

The registry was intended to assist HHS in evaluating the safety and effectiveness of all implantable medical devices, including all orthopedic, neurovascular, cardiovascular, ophthalmic and dental implants. It would link data provided by manufacturers to the U.S. Food and Drug Administration with outcomes data drawn from many sources, including Medicare claims data, electronic medical records and adverse event reports. The registry data and analyses would be stripped of patient information and ultimately made available to the public and the Centers for Medicare amd Medicaid Services (CMS).

The NMDR also authorized HHS to require device makers to submit “such other information as is necessary to facilitate post-market assessments of device safety and effectiveness and notification of device risks” on an annual basis.

While the registry was not ultimately included in the final version of the bill, its proposed creation is an indicator of the potential future government role and direction for tracking medical devices. It is expected that device companies will be inclined to adhere to best practice and embrace many elements of the proposed registry concept for their own use. The industry has adopted the standard for device identification that was originally proposed of its own volition.

What all this boils down to is compliance to the new regulations can occur in stages through 2020 to allow our industry to come into full compliance. Even with a published timeframe for UDI regulation compliance, there are still other regulations and guidance in the works that we have to be vigilant for. After all, the most respected industry trends publishing group, Emergo, in their past few years’ of reporting on the annual State of the Industry for the Medical Device industry find that the biggest challenge faced by the consensus of industry experts is the “Changing Regulatory Environment”.

Biggest Challenges Faced by Medical Device Companies – By Company Size

(Source: Emergo 2014 Survey – segmentation; company size by number of employees (5))

Want More Information?

Visit our web site for information on Portford's Medical Device Tracking software and services.

References

(1) http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200ih/pdf/BILLS-111hr3200ih.pdf
(2) http://www.raps.org/regulatoryDetail.aspx?id=8350
(3) Joch, Alan (October 2008). "A device by any other name". Materials Management in Health Care 17 (10): 16
(4) http://www.mdepinet.org/index.php/registry-task-force/
(5) http://www.emergogroup.com/resources/research/annual-medical-device-industry-survey

Recap EMC World 2015

EMC World 2015 has come to a close with over 12,000 attendees joining us in Las Vegas! The experience continues with EMC World Virtual where you can relive all of the highlights. Click on the link below to access the content:

Medical Device Tracking - The Next Generation

Our Commitment for Best-in-Class Medical Device Management Solutions

To complement our strong expertise in Medical Device Tracking workflow development, we have been actively working to enhance our whole collection of software and service offerings to meet the rapidly changing regulatory environment facing the device industry. One of the greatest obstacles and concerns for the industry is the nascent and coming regulatory changes (1) being imposed upon the industry; the larger the company, the greater this burden is reported. In addition, there is always a core goal for providing health outcomes that meet the best practice that can be delivered for the medical community – Is what we manufacture and aid in the delivery to patients, safe and effective?

At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection

of problems with devices before they become an issue for the companies, regulatory agencies and the patient population. From a recently published report (2) it has been determined that the 510(k) program is in need of modification to support both patient safety and efficacy concerns.

"An alarming number of new medical devices sidestep FDA approval through a system known as the 510(k) program. The FDA typically evaluates new products with stringent premarket testing (PMA), but the process can be bypassed if a manufacturer can demonstrate that its product is “substantially equivalent” to one already on the market, a new medical device can be marketed and implanted in patients without any clinical testing or review of outcomes.

While the 510(k) clearing process provides patients with quick access to innovations in medicine, there is an unsettling consequence: The FDA has cleared a flood of new devices without requiring manufacturers to prove their safety and effectiveness.

From 2005 to 2009, for example, 71 percent of the class III (highest-risk) medical devices cleared through 510(k) were later recalled over safety concerns. Criticizing the potential risks of 510(k)-cleared devices, the U.S. Government Accountability Office has urged the FDA to improve the process for medical device review. Specific actions

were suggested, and the FDA plans to fully comply starting in 2013 with full compliance 2020."

We at Portford Solutions, have both a vision and a mission, to provide the best medical device management software to fulfill your requirements to manage the optimal outcome for your patients and medical providers. We began our initiative by providing a best-in-class Medical Device Tracking software solution accessible by all the required participants from manufacturing, distribution and eventual use of the device in patients. We built our system with an expansive specification that serves as a solid platform for the addition of many new integrated modules providing all the features and services needed to meet both best practice and all regulatory requirements.

Solutions Exceeding Regulatory and Medical Community Requirements

Our current software development is focused on providing the following features to aid your company in meeting and exceeding all the requirements for medical device management and reporting. Development has been ongoing on these enhancements and will be added as modules or incorporated into the core of our solutions in the near future. <

• Seamless integration with the newly established FDA GUDID Webservice Database for delivery of unique, trackable device IDs. The FDA has established a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). Our software will manage the registration and link to the GUDID database beginning at the manufacturing point through eventual use in patients and subsequent follow-up.
• Cloud-based device tracking workflow integrated with manufacturing, distribution and disposition. We make sure nothing “falls through the cracks” with many integrity checks ensuring that all required tasks are performed, recorded and audited in the most secure environment that can currently be implemented.
• Support for the tracking and reporting on the use of complex, compound medical “device” that may be made up of many components being used in patients as a single entity.
• Integration into our workflow of industry-proven imaging repository and image analysis for disposition - from clinical trials, PMA support and post-operative monitoring. The imaging system supports pre-surgery diagnostic images, initial implant and all subsequent follow-up meeting all radiological and photographic standard and PACS compliance.
• Predictive analytics of time-series data to support early decision about device behavior. The analytics system takes as initial input engineering tolerances, expected behavior from previous trial/use data. The model is expanded to include such factors such patient demographics and device behavior collected from both the prescribing data and medical condition reporting. The collection of this Big Data and the predictive model can be used to measure device behavior moving toward exceeding or under-performing expected device behavior.
• The expansion of our current database model will be built on joint industry/government data standards using the harmonization of CDISC and HL7 managed by many EMR system currently in use in hospital, clinic and physician settings.
• Our next generation release will be fully compliant for full breadth of government mandated regulations published with compliance dates published through 2020.
• The expanded design of our system will provide an option for a subscription service to the newly defined FDA PMA reporting portal. The integration of our system and service offering will help you meet the requirements for the new FDA eMDR (electronic Medical Device Report) for electronic submission of required reports. As required, we can also help manage compliance to the Medical Device Reporting regulations supporting MedWatch form creation and submission to the FDA portal for reports.

We have a staff of experts from the medical device and pharmaceutical industries that have helped us define the specification for our expanded offerings. This group is available to provide essential services for your company including:

• Device trial definition, management and reporting
• Expert configuration to provide the best implementation of our system for your devices
• Regulatory preparedness consulting

We take the active position of being leaders driving the adoption of these technologies to tackle the ever-changing regulatory demands being placed upon the industry and to support best practice for delivering the best outcome for patients.

Solutions Delivery for Today’s Market

To deliver our best-in-class solution and services, we have incorporated, into the core of our design, delivery of our solutions on a cloud-based platform. We have adopted a Software as a Service (SaaS) model providing optimal cost and operational efficiencies. We will continue to provide key components of our software for deployment using in-house (On Premise) hosted model for those not ready to adopt our full SaaS model. We welcome the opportunity to discuss our SaaS model and any of particulars about our solutions.
From a published industry study (3), companies who initially implemented cloud technology to decrease costs have also achieved a competitive advantage through implementing this technology. The study found that one out of five organizations is ahead of the curve on cloud adoption. Moreover, they are achieving a competitive advantage by using cloud-based platforms, and not just cutting costs and driving efficiency through cloud computing. The study also points out the ability to use cloud-based big data to make more informed business decisions. This study shows that many businesses are seeing those advantages now, mostly after the initial cloud deployments.
From the well-published experience of others with SaaS systems, adopting our SaaS model for medical device management offers the following benefits:

• Lower and More Predictable Costs: SaaS technology solutions are often lower cost solutions, as they enable health care organizations to avoid the costs of purchasing expensive hardware (e.g., servers) and/or software. The costs of SaaS deployment are also more predictable than on-site technology. SaaS deployment typically requires providers to pay a fixed subscription cost (monthly or yearly). On-site deployment typically requires providers to pay for ongoing costs to support and manage on-site data servers.
• Simpler and Robust Security: SaaS technology deployment “reduces individual maintenance responsibilities and allows even small organizations to benefit, as responsibility for maintaining security is shifted from your organization to the Cloud-based service provider.
• Easier Upgrades and Updates: Our SaaS technology solutions allow us to make upgrades and fixes to the software without end-user involvement. Upgrades and updates to SaaS technology are less expensive and easier to deploy to our 21CFR Part11-complaint platform. Updates are typically deployed in one day; not weeks.
• Improved Accessibility: Using a SaaS solution allows your company, medical providers and staff members to access technology from remote locations. Our Co-located and replicated systems and storage architecture ensures reliability with up-time maintained at 99.7% providing worldwide access—24 hours, 7 days a week, 365 days a year.
• Better Data Exchange: SaaS technology solutions also enable better data exchange, as “data from many organizations are stored and processed in a more uniform way (HL7 and CDISC).”(4) You can use the technology to share information with other providers, health care organizations, and patients.
• Scalable Solutions:Our SaaS solutions are scalable and are designed to increase capacity, performance and number of users to match your business growth.

References

(1) http://www.emergogroup.com/resources/research/annual-medical-device-industry-survey
(2) http://www.drugwatch.com/medical-devices/
(3) http://www.infoworld.com/article/2612710/cloud-computing/believe-it--the-cloud-gives-you-a-business-edge.html
(4) Executive Office of the President – President’s Council of Advisors on Science and Technology. “Report to the President Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward ”, http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdf

The New Technology Behind ApplicationXtender 8.0

ApplicationXtender (AX) 8.0 from EMC is expected to launch in Q4 of this year. Portford has been closely monitoring the progress of AX 8’s development and we can now share some of the new features and enhancements with you.

Highlights

• Built on a brand new engine core
• New HTML 5 viewer to support document viewing, annotation and redaction
• Restful Services API
• Browser-based AppGen and a new AX Admin module

Updated User Interface (UI)

• Angular JS
• Cross-platform
• MVC controls
• Customizable

Restful Services API

• SAML Authorization
• JSON/XML support
• Microsoft .NET 4.5

New Image Capture

• Captiva PixTools.NET toolkit

New Admin UI

• Replaces old Application Generator (AppGen)/AX Admin
• License admin
• Groups/user permissions reports

Updated Web Application UI

• New UI design: import, query and display
• Cross-platform support
• Multi-browser support: Internet Explorer, Chrome, Safari, and Firefox

Updated Web Based Administration Module

• Create and manage AX data sources
• Create, validate and upgrade database schema
• Create and manage AX applications
• Create/import and manage AX users and groups
• Create and manage AX data types
• Manage storage
• Other administrative tasks

DocuNECT Export Connector for Kofax Capture

The DocuNECT Export Connector for Kofax is now available for DocuNECT v4.8 so you can take advantage of the full power of the Kofax platform for use with Portford's Medical Device Tracking and Financial Services solutions based on the DocuNECT Lifecycle platform.

For more informaiton visit our wiki: http://docunect.wikidot.com/adminhelp:installing-the-docunect-export-connector-for-kofax

Portford Solutions Recognized by EMC® Enterprise Content Division for Excellence in Innovation

LOCATION – MAY 6, 2015 – Portford Solutions Group Inc. today announced that it has been recognized with a Partner Innovation Award by the EMC Enterprise Content Division (ECD). Portford and other winners were announced this week at Momentum at EMC World 2015.

The DocuNECT Lifecycle was awarded the Best ApplicationXtender® Solution for excellence and innovation in solution development, design integration, and best practices for implementation and deployment. DocuNECT Lifecycle is a value-add solution for ApplicationXtender that captures, classifies and distributes electronic documents from a number of sources including cloud based services, business applications, and user’s desktops. DocuNECT’s powerful dashboard and reporting capabilities helps track and audit documents from their source right into ApplicationXtender.

“We are delighted to receive this EMC award and are committed to helping customers realize the maximum potential of their ApplicationXtender solution,” said Bruce Bolton, Executive Vice President of Technology for Portford. “DocuNECT Lifecycle has helped customers add new business processes to ApplicationXtender to extend it use throughout the organization.”

"As content management moves from the first to the third platform, we are heavily reliant on our partners to develop and implement innovative solutions that will help our customers get there efficiently,” said Jason Capitel, Chief Revenue Officer, EMC Enterprise Content Division. “We’re thrilled to recognize Portford Solutions for its visionary approach to the ApplicationXtender solution set.”

ApplicationXtender (AX) Preferred partner solutions, such as those offered by Portford, are pre-tested and proven, so organizations can feel confident that these solutions will easily integrate with ApplicationXtender. Using ApplicationXtender, instant document management is easy to deploy, seamless and secure. Most solutions deploy in days, not months, making them ideal for organizations with stretched IT staffs. Find industry and business solutions that enhance ApplicationXtender in the EMC Enterprise Content Solution Catalog.

About Portford Solutions Group, Inc.
Portford Solutions is one of the leading document management service providers that specializes in products within EMC’s Enterprise Content Division. Portford Solutions provides a complete, end-to-end document management service set to its customers, including strategic consulting, implementation, system integration, and support. Portford Solutions has offices located in Ontario, CA and Aliso Viejo, CA.

Website: http://www.portfordsolutions.com

EMC and ApplicationXtender are trademarks or registered trademarks of EMC Corporation in the United States and other countries. All other trademarks are the property of their respective owners.

Whats Happening in the ApplicationXtender World?

The current version of ApplicationXtender is v7.1, which is a Service Pack on the v7.0 release. For more information on what's in v7.0 click on the link below:

http://portfordsolutions.blogspot.com/2014/01/emc-has-announced-release-of.html

Stay Current with Your System
All versions before v6.5 SP2 are end of life, and v6.5 SP2 becomes end of life soon:
- ApplicationXtender v6.5 SP2 ends primary support life on June 30, 2015
- Extended Support Year 1 (Same level of Support) available through June 30, 2016
- Extended Support Year 2 (Best Effort only) available through June 30, 2017

Take Your ApplicationXtender to the Next Level
If you are using ApplicationXtender system as an archival system only, click on the link below to see a blog article about how to use ApplicationXtender Workflow Manager and Connector to automate business processes.

http://portfordsolutions.blogspot.com/2014/09/take-your-emc-applicationxtender-system.html

Use our own product DocuNECT to extend the functionality of ApplicationXtender. Click on the link below to review the top 5 business use cases for DocuNECT:

http://portfordsolutions.blogspot.com/2014/06/top-5-docunect-business-use-cases-for.html

If you need more information then don't hesitate to reach out to us at sales@portfordsolutions.com.

Lexmark to buy Kofax for about $1 billion to Boost Software Business

(Reuters) - Lexmark International Inc, known for its printers, said it would buy Kofax Ltd in an about $1 billion deal that would double the size of its enterprise software business.

Kofax shares were up 45.5 percent at $10.91 in extended trading on Tuesday, just shy of Lexmark's $11 per share cash offer. Lexmark shares rose 8 percent.

PC and printer makers have struggled in the recent past as companies reduced printing to cut costs and consumers shifted to mobile devices from PCs.

Hewlett-Packard Co plans to separate its computer and printer businesses from its corporate hardware and services operations this year.

Xerox Corp has also increasingly focused on IT services to make up for the falling sales of its copiers and printers.

Lexmark divested its inkjet printer business in 2013 and has since boosted its enterprise software business.

The Kofax deal will help the company's Perceptive Software business achieve its revenue target of $500 million in 2016, Lexmark said.

The business makes software to scan everything from spreadsheets to medical images and provides services to banking, healthcare, insurance and retail companies. It contributed about 8 percent to Lexmark's revenue in 2014 and has grown at more than 30 percent in the past two years.

Kofax provides data services to the financial, insurance and healthcare companies such as Citigroup Inc, Metlife Inc and Humana Inc.

Lexmark said it expects the deal to "significantly" expand operating margins in its enterprise software business, which would now be worth about $700 million. It will also add about 10 cents per share to the company's adjusted profit in 2015.

Lexington, Kentucky-based Lexmark, which expects to close the deal in the second quarter of 2015, said it would suspend share repurchases until it pays off its short-term debt in 18-24 months.

Goldman Sachs is the financial adviser to Lexmark, while Lazard is the financial adviser to Kofax.

Lexmark reported $3.7 billion in adjusted revenue in 2014.

Kofax, headquartered in Irvine, California, reported $297 million in adjusted revenue in the year ended June 2014.

Portford's Medical Device Tracking Solution Now Available on DocuNECT v4.8

Portford's 21 CFR Part 821 compliant Medical Device Tracking solution is now available on the DocuNECT v4.8 platform.

Manufacturers are required to track the disposition of compliant devices from manufacturing, through distribution, implanting and patient monitoring. The purpose of device tracking is to ensure that manufacturers establish tracking systems that will enable them to promptly locate devices. Tracking information may be used to facilitate notifications and recalls ordered by the FDA in the case of serious risks to health presented by the devices.

Portford's tracking solution is currently being used by device companies to manage the tracking/follow-up workflow defined by the Part 821 regulation. The solution is now available on Portford's new DocuNECT v4.8 platform.

DocuNECT v4.8 provides the following benefits:

Enhanced Web Service Integration Capabilities to make it even easier to integrate DocuNECT with third party systems to validate patient, physcian and device distribution data.

Enhanced Management Overview with dashboard, provding graphs and reports on the current status of device disposition.

Performance and Security Enhancements have been added to the product to increase security and system response.

On the technical side, the platform is now compatible with the following technologies:

• Microsoft Server 2012
• Microsoft SQL Server 2012 SP1 and 2014 - The image viewer in DocuNECT Web now supports up to and including Java 8
• DocuNECT Web works with Microsoft Internet Explorer 11, Mozilla Firefox v29.0, and Google Chrome v35.0 - Client Tools is now compatible with Microsoft Windows v8.1

If you would like more information on how you can use DocuNECT with your Documentum environment, then contact our sales group sales@portfordsolutions.com.

Portford Releases DocuNECT v4.8

Portford is pleased to announce the release of DocuNECT v4.8. This release has a number of new enhancements:

Introducing the Classification Module

The new classification module allows document templates to be defined that contain business rules that can identify and classify documents. The web-based classification module presents the separation to an operator to review and modify the classification.

The Document Processing Connector

In previous versions we have split out the processing of document OCR, separation and rendering. In v4.8 we have combined all the functionality into one connector called the Document Processor connector. Additionally, this connector now supports multi-processing (with an additional license) so you can scale up the through-put of document lifecycles.

Enhanced Web Services API

We have made significant enhancements to our web services SDK. In previous versions, the SDK focused on the document upload and indexing (primarily operations in the Client Tools). However, in v4.8 we have added document search and management functionality as well.

DocuNECT Performance Enhancements

Performance in DocuNECT v4.8 has also been significantly enhanced to support more document lifecycle throughput and scalability.

Enhanced Lifecycle Functionality

Enhancements have been made to the lifecycle with more settings to support the Document Processor connector and new classification module. DocScript functions (http://docunect.wikidot.com/lifecyclehelp:lifecycle-docscript-functions-v4-8) and Tags (http://docunect.wikidot.com/lifecyclehelp:lifecycle-tags-v4-8) have also been added to provide additional functionality.

Dashboard Enhancements

Dashboards are a way to present or extend functionality within DocuNECT Web. Our standard dashboard has been enhanced to include barcode functionality and the import and export module that can be used with EMC ApplicatrionXtender, DocuNECT DM, and Documentum D7.

Technical Compatibility

We have tested DocuNECT v4.8 against the following components: - Microsoft Server 2012 - Microsoft SQL Server 2012 SP1 and 2014 - The image viewer in DocuNECT Web now supports up to and including Java 7 Update 55 - DocuNECT Web works with Microsoft Internet Explorer 11, Mozilla Firefox v29.0, and Google Chrome v35.0 - Client Tools is now compatible with Microsoft Windows v8.1 For more information on v4.8 Component Compatibility, visit the Wiki page: http://docunect.wikidot.com/adminhelp:component-compatibility-for-v4-8

Take Your EMC ApplicationXtender System to the Next Level!

EMC ApplicationXtender is a powerful document management platform that can provide your users secure access to documents. Did you know that you can do much more with ApplicationXtender? The AX Connector and Workflow Manager can help you take your ApplicationXtender environment to the next level.

Visit the AX Web Site.

EMC ApplicationXtender Connector

EMC ApplicationXtender Connector enables the seamless integration of business applications to ApplicationXtender—without requiring initial programming or on-going maintenance.

With ApplicationXtender Connector, employees can access information quickly and easily from virtually any business application, including Microsoft Office products, mainframe terminal emulators, and browser-based applications, to make better decisions faster and deliver higher levels of customer service.

EMC ApplicationXtender Connector delivers:

• Point-and-click document access — Enable knowledge workers to retrieve documents and information from the ApplicationXtender repository without leaving their line-of-business applications.
• Maximized investments — Eliminate wasteful redundancies by seamlessly integrating existing applications via ApplicationXtender Integration Module.
• No required programming — Easily integrate with applications such as Microsoft Office products, mainframe terminal emulators, and browser-based solutions.
• Floating icon “drop target” — Enable users to capture any value, even from within a web page, to retrieve linked information from the repository.

View the AX Connector Datasheet

EMC ApplicationXtender Workflow Manager

EMC ApplicationXtender Workflow Manager provides a full range of business process management capabilities to improve business performance and reduce costs. By transforming paper-based processes, Workflow Manager helps ensure that better decisions are made faster, cycle times are reduced, and process bottlenecks are proactively discovered and addressed without requiring IT intervention.

Workflow Manager provides process and forms design, business analysis tools, and the ability to manage business processes centrally. Built on Microsoft.NET, Workflow Manager easily integrates with existing applications to improve efficiency in document-based business processes.

EMC ApplicationXtender Workflow manager delivers:

• Workflow console — Manage, integrate, and categorize manual and automated processes from a central dashboard.
• Process and forms designers — Model new processes and forms with easy-to-use, web-based editors.
• Insightful workflow analytics — Optimize processes with powerful tools such as real time alerts, 3D drill-down graphs, and process statistics.
• Robust process reporting — Establish key performance indicators and business activity thresholds to monitor processes and measure productivity.

View the AX Workflow Manager Datasheet



Want more information? Contact us on sales@portfordsolutions.com.

Learn How PITT OHIO Used Kapow to Significantly Reduce Manual Effort in their Customer Services Program

Manually updating B2B portals and internal applications was nearly a full-time job for Customer Service at PITT OHIO. It was even standing in the way of expanding their premium support program. They considered adding staff - until they automated with Katalyst, and eliminated 90% or more of their manual Customer Service effort. Thanks to Kapow Katalyst they can grow their top line by adding premium customers without adding staff.

“We’re seeing about a 90 to 95% reduction in manual effort from our Customer Service Representatives.” – Darren Klaum, Dir. of Business Systems, PITT OHIO Express.

In fact, within weeks, PITT OHIO was able to automate all routine handling of any premium customer’s service requests by reading emails, scheduling shipments, and updating B2B portal status’ all autonomously with NO CODING!  PITT OHIO Success Profile.

Here are some of the other ways we can help:

1.	Reduce DSO (Days Sales Outstanding)
2.	Automate Freight Bidding
3.	Increase Partner & Customer Visibility
4.	Appointment Scheduling& Tracking and Tracing
5.	Streamline Customer & Partner On boarding

 

Useful links:

PITT OHIO Customer Presentation

Lean Logistics Automation/Integration

Want more information? Give us a call on (949) 333 0402 or email us on sales@portfordsolutions.com.

Top 5 DocuNECT Business Use Cases for ApplicationXtender

DocuNECT is a powerful document processing and integration platform that can be used in a number of different ways to add value to your EMC Documentum ApplicationXtender system. We have picked 5 business use cases from our customer base to demonstrate the flexibility and capabilities of DocuNECT.

1. Electronic Document Capture

Business: Insurance Company Functionality Used: Email Capture and Virtual Print Driver An insurance company utilizes ApplicationXtender to provide a repository of customer insurance policies. The company wanted to move towards an electronic capture solution to reduce the amount of paper scanning. They implemented an email capture process that allows users to email documents to a central email address that is monitored by DocuNECT. DocuNECT analyzes the body of the email looking for words and phrases defined in business rules to automatically classify the document type and extract the index data. Their insurance business application generates reports that cannot be exported, but need to be archived in ApplicationXtender. The DocuNECT Virtual Print Driver is used to print reports directly into ApplicationXtender from the business application. The content of the report is analyzed by DocuNECT to extract and assign document index data.

2. Automated Import

Business: Credit Union Functionality Used: Electronic Forms Import The credit union uses different types of electronic forms generated by IMM Online (http://www.immonline.com) and DocuSign Fetch (http://www.docusign.com). DocuNECT sweeps the import locations and imports the different documents into ApplicationXtender. The DocuSign documents are delivered in a ZIP format containing two documents, the original and the signature page. DocuNECT extracts the two documents from the ZIP file and appends them together before importing them into ApplicationXtender. Business: Credit Union Functionality Used: Member Receipt Import and Publishing The credit union produces electronic receipts from each member transaction at the branch. DocuNECT automates the import of these receipts into ApplicationXtender for archive and also publishes the receipts to the credit union's internet based banking system.

3. Automated Export

Business: Tax and Flood Company Functionality Used: Automated Export The tax and flood company stores documents related to different vendors and customers in ApplicationXtender. Once the title process is complete the documents need to be returned to the lender/customer, who each have a specification on how they want to receive the information. The DocuNECT export process allows administrators to set up specifications for each lender/customer that include the format they want the documents and indexes, which AX application to export from, document conversion requirements , whether the package needs to be ZIPed, and how to deliver the package back to the lender/customer (FTP or sFTP/SSH).

4. Business Application Integration

Business: Commercial Broker Functionality Used: SAP Integration The commercial broker uses ApplicationXtender repository and Workflow Manager to manage their invoice approval process. DocuNECT is integrated with the Workflow Manager application to upload invoice header and account allocation information to SAP (http://www.sap.com) FI finance system.  Business: Credit Union Functionality Used: Microsoft Dynamics GP Integration The credit union uses ApplicationXtender repository and Workflow Manager to manage their invoice approval process. DocuNECT is integrated with the Workflow Manager application to upload invoice header and account allocation information to Microsoft Dynamics GP (Great Plains - http://www.microsoft.com/en-us/dynamics/default.aspx) finance system.

5. Document Classification and Data Extraction

Business: Mortgage Provider Functionality Used: Classification Templates The mortgage provider wanted to increase the efficiency of their loan origination process by automating the import, classification and indexing of loan origination documents. DocuNECT's classification and extraction functionality was utilized to create templates to identify different types of loan documents. Once classified, additional rules were applied to extract data from the documents for upload to their loan origination system for processing.

If you would like more information on how you can use DocuNECT with your ApplicationXtender environment, then contact our sales group sales@portfordsolutions.com.

Kofax: The First Mile of Customer Engagement Begins With a Single Step

By Jeff Ballard, Industry Solutions Manager, Kofax (www.kofax.com) On June 15, 2013

Chinese philosopher Lao Tsu once said, “The journey of a thousand miles begins with a single step.” When it comes to doing business in “Age of the Customer”, it is also true that, “the journey of customer engagement begins with the First Mile.”

Today’s customers are more empowered and connected than ever before. They know what they want, and they want transactions to be fast, easy and convenient. That means you need to engage customers in the manner – and from the device – they prefer, whether from a smart phone, tablet, email or in-person. Because if you don’t, they’ll find someone who will.

Developing profitable, long-lasting customer relationships, however, goes beyond just supporting their preferred communication channel. It means addressing the entire customer interaction process, starting from the moment they engage you. This is the First Mile of Customer Engagement.

With information coming into an organization in a variety of formats – mobile, web, email, paper, fax and others – the challenge is to get that information into the appropriate systems quickly and accurately so action can be taken.
For many companies, moving this information from the originating correspondence into the core systems and applications is a manual process. While businesses can capture the document as it enters a system, more often than not they are merely creating an image of the document and routing that image for review before eventually manually re-keying the needed data for further processing.

However, such a process is overly tedious and results in unnecessarily long processing times, more room for error, and greater potential for a security breach involving your customers’ sensitive information.

By leveraging integrated capture and workflow solutions, companies can ingest key customer data quickly, automatically and with fewer errors. The result is greater responsiveness to the customer and greater accuracy during the transaction, leading to heightened customer satisfaction and loyalty. And it all starts with that first step.

See more at: http://www.kofax.com/blog/index.php/the-first-mile-of-customer-engagement-begins-with-a-single-step/#sthash.0MAWNKXo.dpuf

Manage Printing Costs with Equitrac

Equitrac Office print management software helps companies gain control and management of their printing to reduce costs, increase document security and enable sustainability programs. Equitrac Office delivers these benefits by automatically enforcing printing rules, authenticating users and accurately identifying and allocating document costs.
Equitrac Office delivers critical benefits by helping you:

Track print, copy and scan activity company-wide

• Allocate document costs to a department/office
• Set and enforce print/copy quotas to prevent output waste
• Make printing convenient and secure
• Redirect print jobs to more cost-effective devices
• Create useful reports

Equitrac Office software is seamlessly integrated and embedded within today's leading multi-function printers (MFPs) for unparalleled convenience and performance. Compatible with virtually all MFPs widely deployed in businesses of all sizes including healthcare and financial institutions, our software provides the ability to:

• Use the machine’s existing front-panel keypad for authorization and authentication
• Automatically capture all MFP activity and user data
• Login with PIN or swipe-card
• Allocate costs for documents produced on the MFP without any terminals to purchase, install or maintain
• Gain mobility and convenience of Follow-You Printing® (PDF)
• Enhance document security and protect personal information
• Optimize the use of devices with Equitrac's Rules and Routing (PDF)

Read More...

Kofax Mobile Capture

As mobile devices become part of our everyday life, mobile capture is becoming an interesting new concept. Kofax Mobile Capture™ turns a smart phone or tablet into a scanning device which not only captures a document, but can also extract critical data. With this powerful capability field representatives or customers themselves can capture documents, photos and data using smart phones or tablet computers to initiate critical business processes at the earliest point in the process.

Capture Information... Instantly, from Anywhere
		With Kofax Mobile Capture you are able to provide better and faster service to your customers by turning their smart phones or tablets into sophisticated scanning devices. Customers can capture documents, photos and data using smart phones or tablet computers and have the relevant data automatically extracted and sent to your business processes. They can kick off a claim process, send information for a loan application, provide proof of delivery – and thousands of other tasks – all from the palm of their hand. The power of Kofax Mobile Capture enables you to be more responsive to your customers, speed processes, reduce costs and grow revenue.
Enabling your customers to capture information at the Point of Origination™ from virtually anywhere and deliver it to your systems speeds transactions and differentiates you from the competition. Turn any smartphone or tablet into a robust information capture application Automatically optimize the images for highest quality Transform images into editable, searchable information with smaller file size Add meta data Submit the right data to business processes, archives or systems Read More...

Documentum v7

Documentum v7.0 has been released by EMC late 2012 and we wanted to explain the product background as a number of our customers are asking whether they should upgrade to it.

Documentum Content Server v7.0 is a release primarily focused on facilitating the implementation of D2 and xCP v2. There is no WebTop for v7.0, but v6.7. SP2 is certified against this build, as too is xPlore v1.3.

So if you are looking to migrate to a D2/xCP stack then we do recommend the upgrade, however, if you going to stay with the WebTop platform then we recommend staying with v7.0.

As you can see from the changes below they are focused on server operations.

• AES-128 Encryption for TLS/SSL Cryptography
• Enhanced Type Caching
• Intelligent Session Management
• LDAP Nested Group Synchronization
• Support for Kerberos in Multiple Domains
• Projection of the Dormancy Status to Connection Brokers
• Virtual Deployment
• Remote Key Management (RKM)
• ACS Server Dormancy Status
• ACS/BOCS Deep Export Support
• Documentum Messaging Services (DMS) High Availability
• Documentum Messaging Services (DMS) Can Be Installed on Content Server Host
• FIPS 140–2 Compliance
• AES-128 Encryption for TLS/SSL Cryptography
• Widening of User and Group Name Properties
• Better Installation Experience

The release notes are available in EMC's PowerLink, but don't hesitate to reach out to us if you require more information.

Portford is Interviewed on Correlsense Blog

Click on the link below to view Bruce Bolton's answers to a series of Documentum architecture and monitoring questions: 

http://www.correlsense.com/blog/an-interview-with-documentum-expert-bruce-bolton/

Documentum D2 - EMC's next generation interface

EMC have released their new interface called D2, which essentially is long-term strategic replacement to the current WebTop technology and provides the user with a Web 2.0 experience. One major advantage of D2 is the ease of configuration. Although Documentum is an extremely powerful platform, developing applications has been down to technical consultants with Java or web services experience. D2 brings a number of common pieces of functionality into the realm of "point and click" configuration.

Click on the link below to find out more information.

http://www.emc.com/enterprise-content-management/documentum-d2.htm

What's new with Documentum ApplicationXtender?

ApplicationXtender Connector
EMC ApplicationXtender Connector enables the seamless integration of business applications to ApplicationXtender—without requiring initial programming or on-going maintenance. With ApplicationXtender Connector, employees can access information quickly and easily from virtually any business application, including Microsoft Office products, mainframe terminal emulators, and browser-based applications, to make better decisions faster and deliver higher levels of customer service.

EMC ApplicationXtender Connector delivers:

• Point-and-click document access
- Enable knowledge workers to retrieve documents and information from the ApplicationXtender repository without leaving their line-of-business applications.
• Maximized investments
- Eliminate wasteful redundancies by seamlessly integrating existing applications via ApplicationXtender Integration Module.
• No required programming
- Easily integrate with applications such as Microsoft Office products, mainframe terminal emulators, and browser-based solutions.
• Floating icon "drop target" - Enable users to capture any value, even from within a web page, to retrieve linked information from the repository.

ApplicationXtender Secure Store
Encrypted secure connection and compatibility with Microsoft's Encrypted File Serice (EFS) to ensure seamless encryption capabilities for Documentum ApplicationXtender. Secure Store for EMC ApplicationXtender is a secure storage tier for EMC ApplicationXtender. Secure Store is a Microsoft Windows Service with a Web based Administration Interface. The combination of Secure Store and Microsoft EFS makes the deployment of a secure storage tier simple and a affordable. The secure store application provides ApplicationXtender with an encrypted secure connection to Microsoft File Server volumes. Secure Store is a Windows Service that is administered via a web application (simple browser administration). The application is also compatible with Microsoft Encrypted File Service (EFS) that provides seamless at rest encryption.

ApplicationXtender Web Based Administration
User Administration provides a web based User and Group management utility for EMC ApplicationXtender. It utilizes the EMC AppXtender Web CDK technology to seamlessly add user administration functionality.
Supported functionality includes:

• User Management
• Group Management
• AX Native and Windows Security Support
• Permissions
• Alternate Security settings
• Document Level Security
• User password assignment
• Delegated Security support
• Process Id Management