Waiting for Senate to Act on Track and Trace Bill

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.

USDM is already helping many of the world's most well-known medical device companies prepare for the pending legislation.

Legacy Decommissioning: Improves Efficiency and Lowers Cost of Ownership

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:

1.  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

2.  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

3.  Preparing a system retirement plan report to summarize the retirement effort

Garbage In Garbage Out

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.

ECM VAPs Save Time and Money

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:

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

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