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.

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. 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
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. 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.