Big changes for: Life Sciences, Healthcare, and their IT Vendors

The new HIPAA Omnibus rules go into full effect Monday 23 September 2013. There are new regulatory requirements for IT vendors working with life science & healthcare “covered entities”, such as, new required delineated business associate agreements (BAA) contracts related to detailed risk-based assessments and detailed alignments, named HIPAA Security Officers, documented HIPAA compliance and IT training, human genetic information now included in protected health information (PHI) and the list goes on and on…

An in-depth legal review article takes a deep dive into some of the most significant changes that will impact IT vendors and covered entities.

“Final HIPAA Omnibus Rule Brings Sweeping Changes to Health Care Privacy Law: HIPAA Privacy and Security Obligations Extended to Business Associates and Subcontractors”

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Harmonized regulatory risk-based framework for health information technologies

On July 2, 2013 the US Department of Health and Human Services (HHS) has issued the final “Health Information Technology Patient Safety Action and Surveillance Plan” or the “Health IT Safety Plan” http://www.healthit.gov/policy-researchers-implementers/health-it-and-patient-safety

The Health IT Safety Plan has two fundamental objectives:

1. To promote the health care industry’s use of health IT to make care safer; and

2. To continuously improve the safety of health IT.

The HHS Office of the National Coordinator (ONC) for health information technology (HIT) will coordinate with AHRQ, CMS, FDA, FCC and the Office for Civil Rights (OCR) centralizing on FDA’s risk-based regulatory framework for health IT, that protects patient safety, promotes innovation and avoids regulatory duplication.

FDA’s Risk-Based Regulatory Framework

The underpinning of FDA’s risk-based regulatory framework for health IT is Good Informatics Practices (GIP) guidelines.  Today the Introduction and Intended Use and seven chapters or modules have been extensively peer review and published by HIMSS.org.

See: http://ebooks.himss.org/catalog/show/good+informatics+practices/9

①   Executive Summary

②   Infrastructure & Cloud

③   Risk Management

④   Data Management

⑤   Security

⑥   Training & Training Practices

⑦   Validation & Verification

Our friends at Abnology (www.abnology.com) played a significant roll in leading the authorship of GIP’s and utilize GIP’s as their architectural reference in their product the Trusted Health Cloud® enterprise system, released in 2010 and today available in data centers nationally.

We recommend you become familiar with GIP’s.  The GIP’s are a great resource to utilize in the HHS required HIPAA compliance and IT training.

We have made available GIP Executive Summary Introduction and Intended Use publications from HIMSS:

Good Informatics Practices (GIP) Guidance

Good Informatics Practices (GIP) Executive Summary

 

For more information on how this may impact your company, please contact Tridea Partners at sales@trideapartners.com. Tridea Partners is a leading Gold Certified Microsoft Dynamics AX, Dynamics GP, and Dynamics CRM partner serving Southern California and Salt Lake City regions.

This post was written by Howard Asher, Chairman at Abnology, Trusted Health Cloud.

 

Microsoft Dynamics CRM – Leader in Gartner’s Magic Quadrant

Gartner recently published (July 17, 2013) its Magic Quadrant for Sales Force Automation (SFA). The Magic Quadrant is meant to support decision making for CIO’s and business analysts who maintain, or are looking to evaluate and procure, a CRM/SFA solution. The Magic Quadrant highlights the strengths and weaknesses (“Cautions”) each vendor provides with its CRM solution. Gartner typically highlights the functionality that provides innovation and the most value to the company and end users. We’ve reviewed Gartner’s Magic Quadrant for SFA and summarized the key reasons why Microsoft Dynamics CRM is positioned in the Leader Quadrant for sales force automation.

Microsoft Stack

As you would expect, Microsoft Dynamics CRM gets high marks for having seamless integration into other Microsoft business productivity applications including SharePoint for collaboration and content management, Microsoft Lync for presence and instant messaging, Microsoft Visual Studio for extended customization and Microsoft Outlook for advanced email capabilities. In addition, Dynamics CRM utilizes SQL Server as its database and can provide advanced reporting through the use of SQL Server Reporting Services (SSRS). This pre-built integration into other Microsoft technologies adds value by providing a low Total Cost of Ownership (TCO), reduces time spent on maintenance and technical issues.

Enhanced User Interface (UI)

Microsoft Dynamics CRM allows you to view everything you need in one spot – fast and fluid, and relevant to the work at hand. No pop-ups or flipping from one application to the next. In addition, you now have pre-defined or configurable processes – identifying the steps needed to complete the desired outcome. These process guided steps can be setup based on roles, or configured as needed with the process designer.

DynamicsCRM_EnhancedUserInterface

Microsoft Ecosystem

Gartner again points out that one of the main strengths of Microsoft Dynamics CRM is the partner ecosystem. This includes companies like Tridea Partners, who provide industry vertical expertise and proven implementation capabilities. There is also an extensive marketplace for CRM industry add-ons that offer more advanced vertical functionality.

Mobility

With the target release of Dynamics CRM 2013 in Q4 of 2013, mobile sales users can access the application via Windows 8 tablets or iPad. This will also allow for offline viewing if Internet connection is lost or unavailable. Shortly after the initial release, Microsoft plans to complete the mobile story by providing touch-enabled usability on smartphones for Microsoft Windows 8, iPhones and Android.

Dynamics CRM on Tablet

Additional enhanced features not mentioned in the report include:

–          Interactive Business Intelligence – you can click within charts to analyze sales data for quick insights.

–          Social – your entire enterprise can collaborate using Yammer to comment on posts or begin conversations.

–          Real-time (synchronous) workflows – real-time workflows are not queued and execute immediately on-demand or in response to  message being processed by the execution pipeline.

–          Business Rules – tailored, rule-driven business actions that can be applied to CRM forms.

 

This post was written by Brent Garduno, Sales Manager at Tridea Partners. Tridea Partners is a leading provider of Microsoft Dynamics CRM, Dynamics AX, and Dynamics GP serving Southern California and the Salt Lake City regions. For more information on the functionality offered in Microsoft Dynamics CRM, contact sales@trideapartners.com.

 

System Considerations Before Your Life Sciences Company Goes Commercial

There is no question there are many system considerations when it comes to preparing your company to go commercial – each of which will depend on the business model you have and what business processes will be maintained in-house versus what is outsourced.  Such considerations might depend on whether manufacturing and fulfillment would be internal or through both a contract manufacturer and 3PL.  Other considerations include the following:

  • System of Record: Do you want your ERP software system to be the ‘system of record’ where you’ll be able to defend full product traceability in this system for FDA purposes.  Or, will this traceabilty be paper-based?
  • 3PL Integration / Contract Manufacturer Integration: Is your 3rd party logistics provider able to provide data integrations communications of product that was shipped.  How about providing your manufacturer with visibility into sales demand, and you with visibility into finished product or product costing?
  • Serial / Lot Controlled Items: Unless you’ve passed off all inventory responsibility to a contract manufacturing and 3PL, you’ll need full product lot or serial traceability and a means for managing this added element of effort.
  • CRM Requirements: Do you have plans for a CRM system, or the ability for the sales team to easily manage leads, opportunities and prospective client communications and follow ups so that new business doesn’t fall through the cracks?
  • Quality Management: Once sales of product occurs, it important to have strict controls over the inbound product quality and quality control through the manufacturing process.  Only specialized systems can manage these quality considerations.
  • Material Planning: Making sure the right products are available for the forecasted sales activity can become very important for some companies, which means they need to put an MRP and Sales Forecasting system in place to balance supply and demand.
  • Online Ordering / eCommerce: Today’s customer requires much more flexibility into how and when orders are placed for your product in the market.  However, online ordering comes with many complex challenges especially when dealing with FDA controlled products and operations. 
  • Expense Management: Once there is a sales team selling product, there are regulations in place for how they communicate with potential clients and how they can spend money on them.  One of those requirements is outlined in the ‘Sunshine Act’.  Make sure the systems help you managed towards these regulations.

 

If you would like to discuss these system considerations in more detail, or would like an assessment done of your current system, please contact Tridea Partners: sales@trideapartners.com.

This post was written by Andy Collins, Partner at Tridea Partners. Tridea Partners is a leading consulting provider of Microsoft Dynamics AX, Dynamics GP, and Microsoft Dynamics CRM software applications and professional services for the life sciences and health care industry.

Top 5 Reasons to Integrate Dynamics CRM with Dynamics GP

There are many compelling reasons to integrate enterprise CRM and ERP systems, but for this week’s blog, we’ve selected five of our favorite top drivers. We’ll also compare a few of the methods and tool sets available to integrate Microsoft Dynamics CRM with Dynamics GP, as well as list the standard integration templates provided in the most popular integration tool sets.

Our list of Top 5 Reasons to Integrate Dynamics CRM with Dynamics GP:

  1. Reduce manpower required to manually re-enter or copy and paste data between systems
  2. Eliminate data transcription errors
  3. Real-time bi-directional flow of data
  4. Trigger CRM Workflows from changes to data in ERP system
  5. Create reports that accurately combine ERP and CRM data

Before taking a deep dive into the list, I thought I’d answer a question asked by many companies as they select ERP and CRM systems, “Why don’t they just combine all the functionality into one program so we don’t have to integrate?”

  1. The first answer is that Microsoft does provide full CRM and ERP functionality combined in Dynamics AX, the highest end product in the Dynamics ERP family. If a single integrated CRM/ERP system is a requirement for your organization, then you will want to consider Dynamics AX.
  2. My next response is that marketing and sales organizations tend to be very dynamic, constantly experimenting with different business practices, while accounting and operations tend to be much more control, standardization, and compliance oriented. While good ERP systems can be configured to meet a variety of business needs, they are not generally reconfigured as often or to the same degree as CRM systems.
  3. Where accounting and operations processes are tightly intertwined, marketing and sales often operate outside accounting and operations, both geographically and procedurally. There are many touch points, therefore the need to integrate, but marketing and sales departments often act with more autonomy, from a systems perspective, than accounting and operations.

A Deeper Look at the Top Five Reasons to Integrate Dynamics CRM and Dynamics GP:

Reason #1: Reduce manpower required to manually transcribe data between systems

We could subtitle this reason “Spreadsheets, Spreadsheets, Everywhere.” In my 20+ years of implementing ERP and CRM systems, I’ve never once analyzed and documented a legacy business process workflow without management being shocked at the number of times data was copied and pasted or manually transcribed from one system into another. User’s PC and network directories are full of spreadsheets containing data exported from one system, e-mailed to another user, and then re-entered into another system. This is added cost with no added value—waste pure and simple. Even semi-automated processes where data is exported to a delimited text or Excel file, mapped, then uploaded into another system are time consuming and error prone.

Reason #2: Eliminate data transcription errors

Data that is transcribed manually will always, without exception, contain some degree of errors. Data that is copied and pasted is often truncated, pasted into the wrong field, or due to character set issues may place cryptic characters in the data that not only look strange, but can crash processes. Even export/import procedures experience transcription errors when the data itself is the improper data type, contains delimiters that skew the columns, or is manually edited between export and import.

Reason #3: Real-time flow of data

Integrations can be set to post from the source system to the target system immediately upon creation or update of the source record. To illustrate the value of this feature, I will share an experience I had a few months ago. I had been on hold with a business that I was calling to inquire about one of their services. While on hold, I continued to web surf, looking at their competitors’ web sites. One of them caught my attention, and I filled out their web form questionnaire while on hold, then clicked the submit button. Less than 1 minute later I had an inbound call, so I hung up and took the call. It was a sales representative for the company whose web form I had just filled out. A few weeks later on a follow up call, I told the sales rep how he snagged the sale from his competitor. He told me their web portal had a live integration with their CRM system which placed my inquiry into an inbound inquiry queue. He was monitoring the queue and while dialing was reading my responses to the web form.

Reason #4: Trigger CRM Workflows from changes to data in ERP system

One of the great features of Dynamics CRM is the ability to create workflows based on a record being created or an update to the value of a field on a record. The workflows can perform branching logic based on the data event that occurred, creating and assigning a variety of tasks to users, groups, and queues. With the exception of AX, the Microsoft Dynamics ERP systems do not support this level of user configurable workflow. By integrating CRM with GP, changes to a record or field in GP can trigger a workflow in CRM. Here are some examples:

  • Shipment of an order to a customer with a certain Customer Class can trigger CRM to send a shipment notification e-mail to the customer and schedule a telephone call for the sales representative to contact the customer a week later to verify they received their goods.
  • A change to the quantity of an item with a certain Item Class in GP can trigger CRM to create a task for the Master Scheduler to review the item and verify that it will not affect the shop floor schedule.
  • A dramatic change to the standard cost of an item can trigger CRM to create and assign a task to the pricing manager to review the item’s price lists.

Reason #5: Create reports that accurately combine ERP and CRM data

Businesses increasingly rely on the need to track income from the earliest stages of lead acquisition to cash collections, often mining the data for correlations, key ratios, and behaviors that help them understand their business.

Both Dynamics CRM and Dynamics GP are built on the Microsoft platform top-to-bottom, using Microsoft SQL Server as the database engine in which all the data resides. Well written integrations provide cross-references between the CRM marketing and sales records and their corresponding ERP records in GP. Using Microsoft Business Intelligence Development Studio, a component of SQL Server, businesses can create reports that integrate related data from both the CRM and ERP systems. Examples of this include:

  • Complex commission reports where the metrics for determining commission rates may reside in CRM and the invoice payment data in GP.
  • Return on Marketing (ROM) reports where the Campaign data resides in CRM and the cost and revenue data reside in GP.
  • Marketing demographics data correlated with collected invoice data.

Microsoft Dynamics CRM and GP integration

Standard Integrations

Both the Microsoft Dynamics CRM Connectors and Scribe Insight GP/CRM Connectors come with the following standard integration templates:

Dynamics CRM to GP integration

While the Microsoft Connector is a free download and comes with the standard integrations described above, Scribe Insight offers a far more comprehensive set of tools allowing for the creation of custom integrations with a variety of platforms and databases as well as additional features like branching logic and data transformation tools.

Scribe Workbench

Scribe provides an intuitive graphical interface for mapping fields from the source to the target.

Scribe Configure Steps

Scribe also provides a graphical step flow and control editor. Users and developers can easily see the flow of the integration, and track the branching logic that controls steps to be skipped or conditions that would cause the integration to proceed to a specific step.

When using an integration template or creating a custom integration, knowledge of all of the systems to be integrated as well as the integration tool to be used will assure a robust and stable integration. Tridea Partners provides ERP and CRM integration development services using Scribe Insight, the CRM and GP SDK’s (software development kits) for Microsoft Development Studio, and the Microsoft connector for CRM and GP.

 

Written by George Sagen, Senior Application Consultant for Tridea Partners, a Microsoft Dynamics GP and Dynamics CRM consultant Serving Southern California and the Salt Lake City region.

 

Top 10 Process Manufacturing Requirements for Life Sciences

Batch Manufacturing and Process Manufacturing are very unique processes that Life Sciences companies must address to compete effectively while adhering to FDA quality and validation requirements.   These requirements can even apply before commercialization, or if they outsource certain manufacturing processes.  This mode of manufacturing is unique in that groups, formulas or “Batches” of a product are produced at one time, with the end product taking the form of non-discreet units and something that “Cannot be put back together in their original form”.  This finished product often involves the extraction of 1 or more products at the end of production.  Furthermore, the packaging of the end product needs to be independent of the formula or ingredients so the ability to easily change ingredients doesn’t create added steps to redo the packaging process.

There are ERP systems that specifically address this unique set of functionality, including Microsoft Dynamics AX.  These systems have developed a unique suite of functionality specifically to address these batch and process manufacturing requirements, making it an extremely attractive solution for those industries.  Many times these products have to address the complex issues around multi-site manufacturing as well, where the same product might be produced at different locations.  There is also an important quality assurance requirement with these companies whether at the time of receiving raw material items or quality checks throughout the manufacturing process.

There are some software system requirements that, although not specifically related to the mode of production, tend to be present in batch and process manufacturing environments because of the nature of the industries involved (example: lot number traceability in Life Sciences).

When looking into ERP systems for the process and batch manufacturing industries, the following are some of the key areas to focus attention to and make sure that software was developed with the process industry in mind.

Top 10 Requirements for Life Science Manufacturers:

  1. Lot Number Traceability
  2. Transact Co-Products or By-Products (multiple outputs per production run)
  3. Tracking Batch Records or Batch Attributes
  4. Managing Expiration Dates and Shelf Life of Product
  5. Quality Control and Quality Assurance of Purchased and Manufactured Product
  6. Number of Decimal Places for Tracking Inventory Quantities (when very small quantities of an ingredient are used in formulas or BOM)
  7. Manage Different Versions and Updates to a Formula
  8. Tracking Multiple Units of Measure per Product
  9. Planning and Managing the Packaging of Bulk Product into Multiple Forms Based on Actual Yields
  10. Separate Packaging and Production Process to Allow for Quick Formula Changes

 

There are clear differences in the requirements of a process manufacturer from a discrete manufacturer particularly in the life science industry and it is important that the ERP system can address these unique differences.  Make sure the ERP application was development with the process industry in mind, then drill into how it can address your specific requirements.

This post was written by Andy Collins, Partner at Tridea Partners, a Microsoft Dynamics AX Partner located in Southern California.

More information on how Dynamics AX adresses this industry:

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