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White Paper - Best Practice Data Migration Process to Support RIM System Implementations

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Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.

Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.

Publicada em: Saúde e medicina
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White Paper - Best Practice Data Migration Process to Support RIM System Implementations

  1. 1. 1 BEST PRACTICE DATA MIGRATION PROCESS TO SUPPORT RIM (REGULATORY INFORMATION MANAGEMENT) SYSTEM IMPLEMENTATIONS Whether you are a large global Pharmaceu2cal company or a small Biotech awai2ng approval of your first drug product, you will most likely agree and align on the fact that your documents required for a Regulatory Submission need to be well managed, organized and in submission ready format. Companies rely on RIM systems to help them manage and organize these documents accordingly. As smaller companies grow they adopt more sophis2cated technologies. Similarly as larger Pharma transform their opera2ons in an effort to gain efficiencies, they transi2on to more op2mal solu2ons. In either scenario, both companies must undergo a Data Migra2on effort before they can start to u2lize their newly selected solu2on. Garbage In Garbage Out BIGGEST PIT-FALLS OF DATA MIGRATION Most System Vendors have the op2mal solu2on for Data Migra2on, that is, in its most simplest terms, “a tool that will tag all your data and bulk export it from your old system directly into the loca2on it needs to go to in the “new” system”. So what’s the problem? Why is it that aSer the migra2on effort the key stakeholders in the Pharma companies (big or small) are in a frustrated panic aSer the migra2on effort, why is it that they can’t find anything? While the sophis2ca2on of the “bulk export/import” technology works in theory, the reality is, most companies don’t have their documents and Regulatory data organized in a manner to u2lize this technology effec2vely.
  2. 2. DIVING INTO THE PIT 2 WHY ARE SO MANY COMPANIES FALLING IN THE PIT Most oSen then not, the vendors that are advising on the Regulatory Data Migra2on efforts are System Vendors. They advise to bulk export and import. From their perspec2ve this makes the most sense as it is the most effec2ve and efficient way to move data. Which in their defense is actually correct, if and ONLY if the data tags that they apply to the data are meaningful. System vendors advise from a prac2cal “technology perspec2ve not from prac2cal “business opera2ons” perspec2ve. Leading companies to the best technical solu2on that doesn’t always translate to the required business need Op2mal Technology Data Migra2on Solu2on Op2mal Business Opera2ons Data Migra2on Solu2on HENCE LIES THE PROBLEM… System Vendors don’t always have an apprecia2on of the broader complexi2es that come with the thousands, if not millions of documents, and other data types generated as part of the drug development lifecycle. So when they say “we tag the data” and it moves over to the “right” loca2on in the “new” system. It all sounds great, but it all falls apart with the “tag step” Tag from Old System Export From Old System Import to New System WHAT DOES THIS MEAN?
  3. 3. 3 STANDARDIZED METADATA FOR TAGGING THE IMPORTANCE OF STANDARDIZED PROPERTIES ACROSS YOUR REGULATORY INFORMATION Tagging data for migra2on assumes that you have the correct and standardized proper2es (metadata) applied across all document types. In most cases, companies don’t have this in place, and so when the documents are “tagged” the tags are somewhat meaningless as they don’t inform very much, hence they are imported to random loca2ons in the “new” system; leaving the end user frustrated and confused as to where they went and how to search to find them. SOLUTION AND A LONG TERM BEST PRACTICE Develop File Guide Bulk Export / Import the Data Ins2ll Best Prac2ce processes Develop a File Guide to drive standardized proper2es (by specifying Document Types, Naming Conven2ons and Metadata requirements for each file type). Now that you have everything organized, ensure you keep it that way. Implement “Best Prac2ce” processes to ensure all key stakeholders adhere to the newly defined data proper2es, ensuring your data is “clean” for efficient u2lity and searchability. * Even if you are not going through a system migra2on, ensure you have a file guide to drive consistency and standard prac2ces for effec2ve and efficient management of your Regulatory Informa2on. Cleanup Pre Migra2on* Allow the system vendor to “bulk export” your data (because it is the most efficient way to move the data over to the new system). PLAN AHEAD, that some documents may not land in the correct loca2on, have a roadmap that minimizes impact. Don’t risk on-going submissions. Develop a spreadsheet of the Metadata from the legacy system, ensure the informa2on is correct and map the new informa2on in the spreadsheet, use that spreadsheet to populate the metadata for the imported files. IT IS WORTH THE INVESTMENT!
  4. 4. For more information, please contact: Carol Rutkowski Partner Pyxa Strategy Practice Lead crutkowski@pyxasolutions.com 610-973-4141 Pyxa Solu2ons is comprised of a dynamic team of management consultants and R&D subject maeer experts specializing in cross-func2onal R&D delivery stemming from ac2vi2es led by Regulatory Affairs ABOUT PYXA Dalia El-Sherif, PhD Partner Pyxa Consulting Practice Lead delsherif@pyxasolutions.com 610-909-8831 4 Let us support you in organizing your Regulatory Information so that you can focus on the more critical aspects of your business – Drug Development, Launch and Maintenance Pyxa is managed by a team of three seasoned partners and comprised of a solid team of consultants with prior blended exper2se in industry and management consul2ng. Pyxa takes pride in its successful delivery of complex global submissions management engagements. We have extensive experience in supporting Pharma and Biotech companies (both large and small) in their effort to organize and manage their Regulatory Information. We have helped companies develop and implement a “file guide” and standardize the management of their Regulatory documents in prep for a migration and as part of a “cleanup” post migration.