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A Google search for cloud computing will reveal thousands of results. The content of the results varies greatly because the Cloud means different things to different people. Some IT experts will tell you the Cloud just refers to servers that are accessed over the Internet. Others will tell you the Cloud includes anything accessed outside of your physical location via the Internet, such as many types of software. The true definition of the Cloud could be debated all day.

In the life sciences industry, the Cloud refers to server and software solutions. So, you may be asking yourself, why do I need the Cloud? There are many reasons, but here are two big ones.

Cost Savings:
Staying compliant with government regulations is expensive. One study indicates the average manufacturing company spends $2.2 million a year on compliance. Many life science companies spend well above the average because they face more regulations than most businesses. Human cost is the largest share of compliance spending. The life sciences industry is already slated to face even more government regulations in the coming years. The Cloud offers automated solutions that require less manpower.

Always in Compliance:
The life science industry is in an era of vast regulation change. To make matters more complicated, every country is creating their own specific rules that international companies have to follow. The fines for non-compliance can be devastating to a business. The Cloud makes it possible for companies to automatically make compliance changes as soon as new regulations go into effect.

Many businesses end up spending millions of dollars on a huge workforce and hope they’ll be able to keep up with regulation changes in order to stay compliant. Some companies are trying to migrate to the Cloud but don’t know where to start.

USDM’s Life Sciences Cloud practice helps life science companies find the right Cloud technology for your life science business and the right strategy to migrate to the Cloud. Ultimately, implementing systems in the Cloud means your company will be save money on IT costs and always be in compliance with government regulations.   To read more about the benefits of clouding computing for life companies, visit USDM's Life Sciences Cloud practice page.

On September 20, 2013, the FDA announced a final rule for the Unique Device Identification (UDI) system.

A UDI is a unique identifier for each medical device sold in the United States. The UDI along with information on the device’s components must be registered in a global database, known as the Global Unique Device Identification Database (GUDID).

The ruling means that labels and packages of class III medical devices, such as pacemakers and heart valves, conform to new UDI rules by September 24, 2014. Deadlines for class II and I devices occur progressively over the next seven years.

The FDA believes the UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help identify product problems more quickly, better target recalls and improve patient safety.

“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in a press release recently issued by the FDA.

USDM is helping some of the world’s most well recognized medical device companies prepare for the new UDI regulations.

A track and trace bill is still awaiting a hearing in the Senate, where there are supporters from both sides of the aisle.

The bill won approval from the House of Representatives on Sept. 25.

The bill would require pharmaceutical companies to create a database to track their products. The database would enable pharmaceutical companies to comply with the legislation, which gives companies 24 hours to answer questions about a drug’s authenticity.

If the current bill is signed into law by President Obama, pharmaceutical companies will have a 10-year deadline to completely adopt new track and trace regulations.

Federal track and trace requirements would supersede state regulations, such as California’s E-Pedigree law.

Why is legacy decommissioning so important? Because keeping legacy systems alive means high costs for IT to cover maintenance of hardware and software. With aging hardware and software, the 'know-how' for using the systems diminishes quickly and often only a few people within an organization retain specific knowledge around the systems.

As regulated industry implements updated, more compliant solutions for their enterprise needs - legacy systems must be retired or removed from service. Many of these legacy systems contain critical data to meet regulatory requirements. What happens to the data stored in those legacy systems? Decisions must be made as to what data to migrate into the new system. What happens to the remaining data? Where is it stored or archived? How long should the data be stored?

USDM can support you in decommissioning your legacy systems. Our support includes:

Preparing a system retirement plan

  • Determining roles and responsibilities for decommissioning
  • Preparing and executing risk management for decommissioning
  • Documenting the risk management approachDetermining which data needs to be retained and migrated into the new system
  • Identifying data that will be archived
  • Determining how data will be retrieved and formatted for archiving
  • Determining the actions required for ending internal and external support agreements
  • Determining change management required for retiring system(s)
  • Determining the approach for communicating the impact of system retirement

Preparing a data migration plan

  • Document the approach for migrating data into the replacement system
  • Identifying the methods to be used for migrating and or converting data
  • Developing the test strategy and scenarios to ensure data integrity
  • Determine the acceptance criteria for verifying the migration

Preparing a system retirement plan report to summarize the retirement effort

Is your data garbage? Are your attributes fit for the dumpster? Would it be easier to find a document if it were literally in the trash can next to your desk? USDM has a recycling program where we will take all your junk and transform it to beautiful, accessible information- saving time and money.

ECM SYSTEM DATA CLEAN UP

We often encounter clients who complain that their ECM solution does not meet their current needs. Some of the reasons frequently encountered are:

  • The initial system was set up poorly,
  • Over time the system has grown so large and unwieldy (ECM creep) that it is near impossible to find information.
  • Different users use the system differently thus resulting in inconsistent data. This makes navigation and search impossible.
  • The system has redundant information with other systems (such as, ERP or LMS). In most cases, there are discrepancies in the data between the systems.
  • The complaints are usually directed at the ECM platform when in most cases, the platform itself is not at fault. It just needs a bit of an overhaul.

USDM employs a step-by-step ECM data clean up methodology. Some of the steps are:

  • Step 1 DEFINITION: Define "clean" "to-be" environment. Establish requirements for the same. Incorporate additional features such as integration with other systems, new workflows, new metadata, new content to better serve the needs of the users. Ensure robust rules are built to prevent ECM creep or incorrect usage of the system. Ensure strong configuration management is in place.

  • Step 2 CONFIGURATION: Set up the "clean" environment. Perform Conference Room Pilots (CRPs) and mock-ups for user feedback. Establish a comprehensive data dictionary that describes each content type stored in the system and what the content means to the end-users.

  • Step 3 ANALYSIS: In parallel to Step 2, iterate through each logical content group (by department, by content type, by site) and identify gaps between the existing system and the new system. Identify migration strategy (how to get this particular set of content to the "clean" environment).

  • Step 4 MIGRATION: Using a phased approach (by department, by site, by content type) migrate the data over to the new environment.

  • Step 5 COMMUNICATION: Train the users of the system thoroughly on the system and the data dictionary and ensure frequent future audits of the data. Implement rigorous configuration management.

Our extensive experience in the ECM space for the Life Sciences has enabled us to put together best of breed documentation for the implementation and validation of ECM solutions.

These packages can be purchased directly from USDM and comprise of the following documentation for various ECM platforms:

  • Installation and Configuration Best Practice Guides
  • Common Deployment Strategies (80/20 rule of common functionality in a typical Life Science company)
  • Validation Template Documents:

    • Validation Plan
    • Risk Assessment
    • Specification Documents (Requirements, Functional, Design)
    • Qualification / Test Protocols (IQ / OQ / PQ / UAT)
    • Traceability Matrices

In the CRM practice, we routinely observe the underestimation of the regulatory impact on CRM system due to what appears to be routine integration projects with legacy systems. There is a general lack of awareness that when life sciences companies integrate the CRM system with legacy GxP systems, the CRM system becomes an extension of the regulated system As a result new requirements emerge for the management of the formerly unregulated CRM system, which may include the following components:

  • CRM Platform qualification – hardware and software, which may be remotely hosted
  • Application Validation – Selective based on function, or more comprehensive
  • Change control (platform and application)
  • Quality System documentation (training, document control)

The impact on the management of the CRM system will vary based on the legacy architecture of the CRM:

  • If  it is integrated with an existing legacy validated ERP suite on the same qualified infrastructure  platform, less potential impact
  • If  the CRM is hosted on an in-house but separate internal platform and vendor from the integrated system, it can have a greater impact
  • If the CRM is hosted in a SaaS platform or application vendor, the impact is much greater –Why?

Key Principal: The SaaS or 3rd party hosting platform provider should not be operating at a lower level of GxP compliance than that provided for your internally hosted regulated applications!

The CRM practice is devoted to help clients anticipate the regulatory challenges inherent in moving the CRM system into a more comprehensive roll in the enterprise to reduce the cost of compliance and increase the ROI of IT investment which comes from the convergence of corporate systems. This blog will explore the unique evolving role of the CRM system from sales force automation tool to a field service corporate gateway platform to the global enterprise transactional environment, and general purpose application toolkit.

 

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