Information Access & Security on a Budget

What could your business do with an extra $250,000? What would happen if your business lost $250,000? This is the average cost associated with a document security breach. Most small to mid-sized businesses don't consider document management security a priority until there is a breach-but your business is different, and you can think about secure document management today.
 
All organizations have information stored in repositories, file folders, documents or even as email attachments. All companies run the risk that someone within the organization will share sensitive information with an unauthorized third-party-unintentionally.
 
Additionally most companies continue to deploy and enhance firewalls and anti-spyware software, install VPN networks and implement other methods to secure their information. Many of these security measures fall short or fail completely.
 
EMC IRM Services for ApplicationXtender can ensure that your confidential information remains secure.


Watch the Webcast
  Read this Datasheet
  Read the Whitepaper

Power Up ApplicationXtender with DocuNECT

DocuNECT is an electronic document capture and migration solution that captures electronic documents from their source, extracts and organizes the necessary business data, and then distributes it to a third party business application to make the information readily available.

Visit our DocuNECT for AX Solution Page

What is DocuNECT?

The following online presentation provides an overview of DocuNECT:

 












Access our library of demos by clicking on the icon below:

Key Functions

Desktop Capture Applications: Easily capture documents directly from the desktop, using the Virtual Print Driver, the Windows Explorer or Microsoft Outlook integration

Using Multi-Function Devices: Utilize multi-function or network based scanners to capture documents for indexing using DocuNECT's web based indexing application

Exporting Documents from AX: Export documents from AX in a number of different formats

Automating Document Import: Automate document imports from third party vendors, web sites, FTP/sFTP sites and more

Automating Indexing: DocuNECT can extract and apply business rules against the content of documents to automate the indexing process

File Share Migration: Migrate legacy file shares into AX, applying business rules to the folder structure and/or document content to populate the AX index values

Mitigating Risk and Ensuring Compliance

Regulations ranging from Sarbanes-Oxley to HIPAA to the new Federal Rules of Civil Procedure, place a new urgency on the need for organizations of all sizes to store and manage their documents securely and efficiently. Doing so ensures document integrity and enables documents to be quickly produced in response to regulatory requests, subpoenas and litigation requests and can:

• Eliminate the risk of paper documents that are easily lost, misplaced, altered, or exposed inappropriately
• Provide a verifiable audit trail
• Set and enforce policies for safe disposition of documents when their retention period has ended
• Enable fast and cost-efficient access to documents in the event of litigation

EMC's instant document management solution, ApplicationXtender, can help businesses create, safeguard and access records and cost-effectively archive or destroy them according to system-enforced administrative, regulatory, or legal rules. ApplicationXtender is an out-of-the-box solution that can be deployed quickly and produce an immediate ROI for most companies.

Read the Whitepaper
Watch the Webcast
Read this Customer Report

Need to Capture Electronic forms into Documentum ApplicationXtender?

Using a combination of the DocuNECT Desktop Capture applications and automated indexing provides a great solution for capturing electronic forms. Features include:

• Capture electronic forms created in Microsoft Excel, Microsoft Word, XML/HTML and Adobe PDF Forms
• Submit the forms using the Virtual Print Driver, Desktop Capture or via Email
• Utilizes existing applications to complete forms (Microsoft and Adobe Reader), which makes DocuNECT a cost-effective forms capture solution

		DocuNECT - PDF Electronic Forms This demo show how PDF electronic forms can be captured and processed by DocuNECT
		DocuNECT - Microsoft Word Electronic Forms This demo show how Microsoft Word electronic forms can be captured and processed by DocuNECT
		DocuNECT - Microsoft Excel Electronic Forms This demo show how Microsoft Excel electronic forms can be captured and processed by DocuNECT

Two New Ways to Keep Updated

There are two new ways to keep updated with Portford news:

DocuNECT for Documentum ApplicationXtender

Portford is pleased to announce the release of our new DocuNECT for Documentum ApplicationXtender (AX) web site that provides literature, presentations and demonstrations on how to add value to an AX environment.
Visit the site now at: http://docunect.wikidot.com/docunect-for-documentum-applicationxtender
Need Information?
Email Gena Barber at: gena.barber@portfordsolutions.com

EMC and Portford - Life Science Solutions

EMC Life Sciences solutions enable you to respond to the changing life sciences value chain by becoming more agile. Our solutions accelerate collaboration and improve management of information flows from discovery through clinical trials, drug approval, and product launch.

With EMC Life Sciences solutions, you can bring high-value therapeutics to market faster. EMC technology solutions such as unified storage, cloud computing, and virtualization solve business challenges. We help you optimize resource utilization, save costs, and improve data sharing for more intelligent ways of working.

Key Benefits

• Collaboration: Increase business productivity and operational efficiency to ensure the right information at the right place.
• Reduced Cost: Reduce clinical trial costs with regulatory submissions planning and electronic trial master file (eTMF).
• Faster Time to Market: Improve business efficiency and agility, and use collaborative authoring to speed drug development.
• Compliance: Portford has developed an application on top of the Documentum platform that manages the compliant lifecycles of documents.

Solution Features

• Document Types and Categories linked to your Records Retention Schedule.
• Compliant Lifecycles and Approval Workflows with CFR 21 Part 11 Compliant Signatures.
• Easily Build a Document Approval Matrix based on Document Type and Category.
• Document Watermark Profile Assigned by Document Type and Category.
• Standard Operating Procedure (SOP) Lifecycle with automated periodic review.

Solutions

• EMC Consulting for Life Sciences: Align business and technology strategies across the life sciences value chain to improve efficiency while offering the controls needed to ensure compliance.
• Solutions for SAP: Address SAP information infrastructure requirements for enterprise content management, intelligent cloning, data protection, business intelligence, data warehouse, data protection and security, SAP archiving, and SAP landscape optimization.
• Infrastructure Consolidation and Optimization: Rely on EMCs holistic, information-centric approach to application, database, storage, server, and data center consolidation as well as data center relocation and migration.
• Information Security: Protect your critical data throughout its lifecycle and accelerate your business with advanced management and security solutions.
• Virtualizing Information Infrastructure: Leverage EMC on your virtualization journey and supply your environment with flexibility, control, and choice of infrastructure.

For more information, please contact Gena Barber at (949) 333-0331 or gena.barber@portfordsolutions.com.

EMC and Portford - Public Sector Solutions

Budgets are tight, resources are scarce, and citizen expectations remain high. How can governments cope? Many state and local agencies have found relief with EMC business and technology solutions.

By consolidating infrastructures, sharing services, and connecting government departments, governments are able to improve their workforce efficiency, drive down IT costs, and continue to deliver exceptional citizen services. EMC has deep industry and technical expertise to help you simplify your government transformation for the next generation of public service delivery.

Key Benefits

• Better Citizen Services: Connect people, information, and agencies to deliver better services at less cost and risk.
• Efficiency: Consolidate your IT systems to improve operations and achieve greater return on investment.
• Cost Optimization: Address budgetary pressures by improving productivity and enabling more flexible and scalable IT services.

Solutions

• Justice and Public Safety: Modernize and streamline your justice systems to make more informed, timely decisions to maximize efficiencies, save costs, and reduce crime.
• Revenue, Finance, and Taxation: Improve tax and revenue services while reducing costs by automating processes, simplifying data management, and enhancing operational efficiencies.
• Social Services and Benefits: Consolidate, modernize, and streamline processes to deliver the best-quality services at the lowest cost and least risk.
• Transportation, Planning, and Environment: Manage growing urban populations by simplifying data management, increasing IT efficiencies, and ensuring protection of citizens as well as data.

For more information, please contact Gena Barber at (949) 333-0331 or gena.barber@portfordsolutions.com.

EMC and Portford - Education Solutions

EMC brings sophistication to K-12 and higher education teaching and learning. EMC has cost-effective solutions for instructional support, student information management, and physical security to protect the faculty and student populations.

With EMC solutions, educators can protect valuable student records, provide collaboration tools for the sharing of research and operational data, and bring innovative technologies to the classroom. EMC brings education into the 21st century to reduce complexities, increase collaboration, and deliver optimal student support.

Key Benefits

• Teacher Effectiveness: Enable staff to share ideas, collaborate, and become more effective at delivering student services.
• Student Performance: Leverage next-generation learning methods to improve delivery of information-based student services.
• Operational Efficiency: Automate administrative processes and ease management challenges for faster, easier operations.

Solutions

• Higher Education: Drive students and faculty to higher levels of creativity, performance, and interaction with transformative IT solutions from EMC.
• Elementary and Secondary Education: Transform classroom learning technologies to improve student performance and drive operational efficiency.

For more information, please contact Gena Barber at (949) 333-0331 or gena.barber@portfordsolutions.com.

Visit Portford on Linkedin

Come and visit our LinkedIn Profile.

Instantly Increase Employee Productivity

Enabling employees to stay within their primary business application while simultaneously accessing relevant documents from another application, such as Microsoft SharePoint or SAP is key to dramatically improve efficiency, accuracy, departmental productivity and even increase customer satisfaction as transactions are completed faster.

ApplicationXtender, an instant document management solution from EMC, was designed with these employees in mind. This out-of-the-box solution enables the seamless integration to business applications without requiring initial programming or on-going maintenance, allowing employees to be more productive.

Learn how instant document management can extend the reach of your critical business applications. Click here to schedule an appointment with one of our Instant Document Management Specialists

Read the Datasheet
Watch this Recording
Read the White Paper

Need to Upgrade? - End Life Product List

This article provides the end of life support dates for the different products that we support. What does an end of life mean?...well this essentially means that the software vendor no longer provides support services and will not be developing new releases/patches for it as newer versions are available. If you have issues with a end of life version then it is quite likely that the issue will be resolved in a supported version. Our professional services team can help you plan and perform an upgrade to your software system.

Documentum ApplicationXtender Product Suite
v5.3, v5.3 SP1, v5.3 SP2, v5.3 SP3, v5.3 SP4	6/30/2010
v5.4, v5.4 SP1	12/31/2010
v6.0	No End Of Life Date Scheduled
v6.5	Current Version. No End Of Life scheduled
Documentum eRoom
v7.3.4	5/31/2011
v7.4.0a	3/11/2011
v7.4.1	5/13/2011
v7.4.1.a	5/13/2011
v7.4.2	Current Version. End Of Life: 1/12/2012
Documentum D6 Product Suites
v6.0, v6.0 SP1	8/31/2011
v6.5, v6.6	No End Of Life Date Scheduled
v6.7	Current Version
Kofax Ascent, KTM and Xtrata
Ascent v7.x	3/31/2011
Ascent v8.x	8/31/2011
Ascent v9.x	No End Of Life scheduled
Ascent v10.x	Current Version. No End Of Life scheduled
KTM v3.5	5/21/2010
KTM v3.5 SP1	5/21/2010
KTM v4.0	No End Of Life scheduled
KTM v4.5	No End Of Life scheduled
KTM v5.0	No End Of Life scheduled
KTM v5.5	Current Version. No End Of Life scheduled
Xtrata v3.1	3/1/2009
Xtrata v3.1 SP1	3/1/2009
Xtrata v3.1 SP2	5/21/2010
Note: The Xtrata product is being discontinued.
Captiva InputAccel
v5,3, v5,3 SP1, v5.3 SP2, v5.3 SP3, v5.3 SP4	3/31/2012
v6.0, v6.0 SP1	12/31/2012
v6.5	Current Version: : End Of Life: 3/31/2014
Portford's DocuNECT
Note, all v3.x CMS products are no longer supported.
v4.1, v4.2, v4.3	12/31/2011
v4.4	12/31/2012
v4.5	Current Version. No End Of Life scheduled

Information Access and Security on a Budget

What could your business do with an extra $250,000? What would happen if your business lost $250,000? This is the average cost associated with a document security breach.

Most small to mid-sized businesses don't consider document management security a priority until there is a breach-but your business is different, and you can think about secure document management today.

All organizations have information stored in repositories, file folders, documents or even as email attachments. All companies run the risk that someone within the organization will share sensitive information with an unauthorized third-party-unintentionally.

Additionally most companies continue to deploy and enhance firewalls and anti-spyware software, install VPN networks and implement other methods to secure their information. Many of these security measures fall short or fail completely.

EMC IRM Services for ApplicationXtender can ensure that your confidential information remains secure.

Be proactive - think about secure, affordable document management today. Click here to schedule a call with one of our Instant Document Management Specialists today.

Watch the Webcast

Read this Datasheet

Read the Whitepaper

Webinar: A Solution for Device Tracking

Portford Solutions Introduces: DocuNECT for Device Tracking
Medical Device manufacturers are required by the FDA to track certain types of devices from manufacture through the distribution chain. The FDA released 21 CFR Part 821, which governs the requirements around the tracking process.

Flexible Software Solutions
• On-Site: Software implemented behind your firewall
• Hosted: A SaaS model where you can pay monthly

Outsource Your Process
Portford also offers a complete managed service that combines the SaaS model with our call-center of trained device tracking specialists that will manage the entire process. Our services begin with fully documented policies and procedures that aid with FDA compliance.

Each client is allowed to customize the workflow to meet the profile of your device or specific needs. The operations team then follows these policies and procedures and conduct regular audits to verify compliance. We have a wide variety of reports and reporting methods which employ industry standards and tools.

DocuNECT for Device Tracking - Overview and Demonstration
Join us to learn about Portford's DocuNECT solution for 21 CFR Part 821. Space is limited!

WHEN: 9/7/11 at 10:00am PST.

WHERE: Online Webinar via WebEx.

If you want more information on Portford's device tracking solutions contact Gena Barber at gena.barber@portfordsolutions.com.

View the Full Invitation:
http://www.portfordsolutions.com/company/events/DeviceTrackingAug2011.html

Reduce Paper to Deliver Quick ROI

Replacing time-consuming paper-based processes can result in substantial time and cost savings and deliver a quick ROI -- which is what a west coast construction materials company recently experienced.

In a normal month of shipping and delivery activity, the company was generating up to 20,000 weight tickets. With such a large monthly volume, the company had outgrown its labor intensive process for accessing, storing and sorting the weight tickets. In the past, to respond to customer requests for signed delivery tickets, the accounting staff would need to search through files of paper originals to locate the requested ticket -- assuming it was filed in the proper place to begin with.

The company selected EMC ApplicationXtender, an affordable, easy to implement, automated document management solution that allowed the company to electronically capture the weight tickets and store them in a centralized repository, enabling easy access and instant retrieval. In addition to the weight tickets, the company is now scanning in up to 100,000 accounts payable documents per month into the ApplicationXtender repository.

According to the company's IT Manager, implementing ApplicationXtender has "changed the way we do business by integrating and streamlining our accounting processes and by enhancing our project managers' ability to execute multiple projects at once."

To find out how your company can streamline your paper-based processes and enjoy a quick ROI, click here to schedule a call with one of our Instant Document Management Specialists today.

Watch the Webcast

Watch this Recording

Use the calculator

Portford's Instant Document Management Site Released

We are pleased to announce the release of our Instant Document Management site that provides everything you need to know about our transactional document management solution. Click on the link below and register for more information:

http://www.axinstantdocmgmt.com/portford


Capture paper documents and forms as digital data, manage them in secure electronic storage, then search and share them easily from your desktop – saving you time and money. ApplicationXtender is the leading document management solution for departments and midsize organizations. Provide additional value to your ApplicationXtender system by adding Portford’s DocuNECT solution for electronic document capture. Don't hesitate to contact us if you want more information on our Instanct Document Management site.

Document Management Systems, does one size fit all?

Over the years document management software vendors have tried to produce a platform to meet the requirements of the entire enterprise, in all document management categories. An early philosophy was to centralize every piece of content into one repository. More conventional thinking is to have different systems to more comprehensively meet the requirements of the enterprise while unifying the user experience via portal technology.
 
The different document management categories:

• Core Document Management - This can be considered an extension to the corporate file-share, organizing documents with a defined taxonomy (attributes, security, foldering, categorization etc). Library management controls the version control of documents, with audit trails and security providing a foundation for compliance
• Web Content - This category focuses around web content authoring and delivery, and allows sites to be organized into static and dynamic content delivery with real-time site updates
• Imaging Management (Transactional) - This category can sometimes be called transactional document management (documents resulting from a business transaction, such as invoices, POs, Bill of Laden, Patient Records, Loan Documents etc). These systems are designed to manage a high-volume of fixed content and as the documents can be large these system can have technology to deliver small sections of the documents to client at a time to increase performance. Report management can often be in this category, which is sometime called COLD and is a technology that ingests, separates and extracts data from reports produced from business applications
• Collaboration - Can be considered an extension of the Core Document Management category and includes content into different collaboration methods, such as blogs, wikis, discussion groups, and web content based presentation to allow team of users to interact and work with the content
• Capturing Content - All the above system categories need a way of getting content or documents into them, and this category is often overlooked but can be considered one of the most important aspects. The more content that is under the control of the system, the more value it has

When selecting a system, you have to compare your requirements against the different categories as you may not need all components. Also, if you do select different components from different vendors, make sure you have a way of unifying user access.

EMC World Debrief

I attended EMC World and just wanted to give my thoughts on the different sessions and messaging around the software supported by EMC's Intelligent Information Group (IIG). 

On the "classic" Documentum products, the message is client unification with development moving firmly towards the Documentum Foundation Services (DFS) model and away from the WDK environment. CenterStage is becoming their main focal point of the web presence and as this does not have feature parity with WebTop or eRoom quite yet, the product management team emphasized that this was a journey as many customers have invested heavily in WDK based customizations. The mobile strategy is progressing with an iPad application promised by the end of the year. Work will also be done to unify the development tools surrounding the platform to make it easier to build Documentum based applications. The xCP platform still plays a large part of the strategy with a focus for partners to build industry specific business process solutions.


For collaboration users, eRoom will have another release towards the end of the year that will support the Microsoft Windows 2008 and SQL Server 2008 platforms, along with other technology certifications.
The messaging around the cloud was definitely the primary tagline, with all product families having some sort of cloud based access in their product roadmaps.

Bruce Bolton
(bruce.bolton@portfordsolutions.com)

So that's the update, client unification and cloud based computing is the message.
For transaction document management users, EMC's ApplicationXtender(AX) platform is here to stay and supports a roadmap that included more workflow enhancements and again more focus is on the client tools and UI. A new connector application is planned that will more tightly integrate AX with the desktop and document access from business applications. Although the technology roadmap remains Microsoft based, the AX team have made a significant move towards web services with a feature rich services based toolkit. Also many of the new applications are based around the web services approach.
Integrations were also announced with Box.net (http://www.box.net/) for cloud based storage access and with Cisco's WebEx (http://www.webex.com/) online collaboration tool.

Documentum v6.7 Now Released

On behalf of the EMC Information Intelligence Group, we are very pleased to announce the General Availability of Documentum 6.7. 6.7 is a stack release that consists of quality improvements, performance improvements, support for additional standards, and select new features. We have introduced stack-wide usage tracking and reporting into the 6.7 stack and many of our most widely used products incorporate this capability.

Release Highlights

• Support for Office 2010
• Business Activity Monitor Enhancements
• Composer Streamlined User Interface
• Content Intelligence Services Now Has Support for Linux Support,and Office 2010 files
• Content Server now has Macintosh file Support for EMC Centera connector
• Documentum Reporting Services has Support for Crystal Report Designer 2008
• TaskSpace has Improved Section 508 Compliance and Support for IGC Brava 6.2 Viewer
• Webtop now has Java 2 security support and Stronger compliance with security standards
• xPlore now available in fully 64-bit mode which increases the maximum file size that can use the exact match to a query
• Retention Policy Services has Consistent language support across Records Manager, RPS, and Physical Records Services
• Usage Tracking and Reporting Enhancements for the different Documetum Modules
• New Certifications in Documentum 6.7 for Application Server: JBoss Enterprise Application Platform 5.1, Browsers: Safari 5.0, Firefox 3.6.12.1.1

DocuNECT v4.4 is Now Released!

Portford has announced the release of DocuNECT v4.4, with the following new features:

• Microsoft .NET v4.0 Support
• Microsoft Windows 2008 R2 and SQL Server 2008 R2 support (32 and 64 bit)
• Microsoft Internet Explorer v9 Support
• Support for the newly released Documentum 6.7 for distribution
• Enhancement have been made to the DocuNECT OCR engine (http://www.aquaforest.com/
• Enhancement to the DocuNECT server to increase performance and error handling
• All Desktop Capture tools now compatible with Microsoft Windows 7 (32 and 64 bit)
• Connector development can now be performed using Microsoft Visual Studio 2010
• Security enhancements to allow for password strength and expiration
• DocuNECT new Data Management features include stronger support for external database for lookups, including SQL statements and stored procedures that allow system parameters to be passed in for additional filter
• Values within the database lookup can be searched
• Picklist in Cabinets can now be attached to tables and support cascading so one picklist can be based on the value of another
• Built-in system connectors that automatically monitor the storage location space, clear logs in a specific timeframe, purge distributed batches. There is also a connector that automatically manages the connector logs so a roling log of a certain number of days can be kept
• Batches can now have text labels and store the capture lifecycle that originally generated the batch
• Group name expanded to 50 characters
• Website change: in the Barcodes module, Print Cabinet Indexes section, when generating the barcodes, the empty index values are replaced with "NULL" values, as empty barcodes are invalid

Visit the DocuNECT wiki for more information about DocuNECT (http://docunect.wikidot.com/)

EMC, IBM, and Microsoft Team Up to Improve Enterprise CMS Interoperability

EMC, IBM, and Microsoft have been working together to develop a specification which uses Web Services and Web 2.0 interfaces to enable applications to inter operate with multiple Enterprise Content Management (ECM) repositories by different vendors. The companies intend to submit the Content Management Interoperability Services specification to OASIS (Organization for the Advancement of Structured Information Standards) for advancement through its rigorous standards development process.

The ultimate goal of CMIS is to dramatically reduce the IT burden around multi-vendor, multi-repository content management environments. Currently, customers must spend valuable time and money to create and maintain custom integration code and one-off integrations to get different ECM systems within their organizations to "talk" to one another. The specification will also benefit independent software vendors (ISVs) by enabling them to create specialized applications that are capable of running over a variety of content management systems.

Working together since late 2006, the three companies were joined in the creation of the CMIS draft specification by other leading software providers including: Alfresco Software, OpenText, Oracle and SAP. A final gathering of all seven companies was recently held to validate interoperability of the specification before submission to OASIS.

EMC, IBM, and Microsoft have been working together to develop a specification which uses Web Services and Web 2.0 interfaces to enable applications to inter operate with multiple Enterprise Content Management (ECM) repositories by different vendors. The companies intend to submit the Content Management Interoperability Services specification to OASIS (Organization for the Advancement of Structured Information Standards) for advancement through its rigorous standards development process.

Key to the new specification, EMC, IBM and Microsoft worked together to define an interface that:

• Is designed to work over existing repositories enabling customers to build and leverage applications against multiple repositories—unlocking content they already have
• De-couples web services and content from the content management repository, enabling customers to manage content independently
• Provides common web services and Web 2.0 interfaces to dramatically simplify application development
• Is development platform and language agnostic
• Supports composite application development and mash-ups by the business or IT analyst
• Grows the ISV and developer community

For more information, and to download a preview copy of the CMIS technical specification draft, please visit the IBM or Microsoft web sites or contact info@portfordsolutions.com today

Hosted Document Management Solutions

Portford Solutions and EMC Software is pleased to announce the availability of subscription based ApplicationXtender software licensing to our industry leading suite of hosted services. Over the last few years a growing number of customers have benefited from securely managing their documents and data via "the cloud" powered by Portford's state-of-the-art data center. ApplicationXtender is an ideal hosted solution for customers that require an instant document management solution that minimizes the costs and risks of paper while increasing productivity by streamlining the capture and management of documents. ApplicationXtender scans, stores, retrieves, and preserves information, while providing role-based access from either a desktop interface or web browser. A hosted ApplicationXtender document management solution can instantly provide your organization with the following benefits.

• Unlimited points of secure access
• Predictable monthly operating costs
• Infinite salability
• Automatic upgrades to the latest versions of AX
• Minimal internal technical resources and infrastructure
• Quick deployment and instant results

Portford's hosted document management solutions are a perfect compliment to our quality document conversion services. For customers that use Portford's document scanning and hosting services, all it takes is an email or phone call to schedule a pick up of boxes or legacy file formats. The next days documents can be accessed securely via the web. This can be an ideal solution for organizations lacking the IT and records management resources required to implement an end to end document management solution internally. Hosted services customers can opt to bring their hosted solution in-house at any point after the first year without penalty or data transfer charge. Portford's dedicated technical support staff can work with your IT department to export documents and data or even deliver all hosted content via sFTP or external drive.

Hosting Services are a perfect solution for organizations that are quickly outgrowing their IT infrastructure or simply looking for a quick and cost effective way of securely managing documents and information between remote offices. Contact your dedicated Portford account representative today to discuss how hosting can improve your business.

For more information on Portford's Hosting Services email info@portfordsolutions.com today.

Outsourced Device Tracking - 21 CFR Part 821

Portford Solutions Introduces DocuNECT for Device Tracking

Medical Device manufacturers are required by the FDA to track certain types of devices from manufacture through the distribution chain. The FDA released 21 CFR Part 821, which governs the requirements around the tracking process.

In response, Portford has developed DocuNECT, a web-based Device Tracking solution that is available in two ways:

• On-Site: Software implemented behind your firewall
• Hosted: A SaaS model where you can pay monthly

In addition, Portford also offers a complete managed service that combines the SaaS model with our call-center of trained device tracking specialists that will manage the entire process. Our services begin with fully documented policies and procedures that aid with FDA compliance.

Each client is allowed to customize the workflow to meet the profile of your device or specific needs. The operations team then follows these policies and procedures and conduct regular audits to verify compliance. We have a wide variety of reports and reporting methods which employ industry standards and tools.

Click here to save the January 27, 2011 WebEx meeting in your Outlook Calendar or contact: info@portfordsolutions.com for more information about new product features or join us for a WebEx demonstration on January 27, 2011 at 10:15 am PST.

What Devices Need Tracking
The FDA mandates organizations to track the following medical devices:

• Glenoid Fossa Prosthesis
• Mandibular Condyle prosthesis
• Temporomandibular Joint (TMJ) Prosthesis
• Abdominal Aortic Aneurysm Stent Grafts
• Automatic Implantable Cardioverter / Defibrillator
• Cardiovascular Permanent Implantable Pacemaker Electrode
• Implantable Pacemaker Pulse Generator
• Replacement Heart Valve (Mechanical only)
• Implanted Cerebellar Stimulator
• Implanted Diaphragmatic / Phrenic Nerve Stimulator
• Implantable Infusion Pumps
• Silicone Gel-Filled Breast Implants
• Cultured Epidermal Autografts

Customer Challenges
The FDA released 21 CFR Part 821, which governs the requirements around the tracking process. The regulations were released in August, 1993 which has allowed a number of companies to become familiar with the regulation of data that needs to be collected and the follow-up processes that are required to insure reasonable attempts to obtain the data.

In practical terms managing Device Tracking comes with its own set of challenges. They include:
FDA Regulatory / Compliance

• Risk Due to Lost Data
• Inconsistent Follow Up

Multiple Systems and Technologies

• Located in Many Locations
• Incompatible Formats
• Lack of Technical Resources

No Consistent Protocols and Processes

• Lack of Information Control
• Privacy Concerns
• Require Heavy Customization

Lack of Reporting Tools

• No Strategic Dashboard
• Obsolete Reports
• Lack of Audit Trail

Labor Intensive

• Overly Manual Intervention Required
  
• Lack of Facility Space
• Lack of Audit Trail to Focus on Core Competency

How do you feel your organization measures up when it comes to efficiencies gained through outsourcing your Device Tracking? Contact Portford today to discuss best practices in your industry and identify how your business processes can be improved.

DocuNECT Features
DocuNECT is a robust and versatile option for your Device Tracking needs. Our services begin with fully documented policies and procedures that aid with FDA compliance!

Each client is allowed to customize the workflow to meet the profile of your device or specific needs. The operations team then follows these policies and procedures and conduct regular audits to verify compliance.

Benefits of DocuNECT for Device Tracking include:

• Facilitates FDA Compliance
• Proven Validated System

One Centralized System

• One Hosted Location
• On-line Access 24/7/365
• Dedicated Technical Staff

Validated System Designed Specifically for Medical Device Tracking

• Automated Workflow Ensures Consistent Patient Data Follow-Up Process
• Compliant Solution 21 CFR Part 11 Electronic Signatures Enabled
• Patient Data Management According to HIPAA Guidelines
  Managed Tools Include
• Management Dashboard
• Real Time Reporting
• Audit and Reconciliation

Managed Workflow Include

• Automated Faxing In / Out
• Predetermined Review and Escalation
• Dedicated Scanning and Indexing Center

Contact info@portfordsolutions.comto learn more about DocuNECT for Device Tracking.