I hope everyone had a
great holiday season and found time to spend with family and friends.
I am looking forward to a great 2019.
Towards that end I
wanted to offer a few of my own personal insights for the pharma serialization
space in 2019 followed by an update on new consulting, solution and service
offerings from Jennason.
Predictions for
pharma serialization in 2019
With the Nov 2018
DSCSA serialization milestone having passed the industry is in a unique
position. As more and more companies enter a fully serialized world,
we will experience the first true test of how well implementations are
performing.
Some bumps have
already been experienced- the question is whether it will become a trend?
Some bold
predictions for 2019
1. As the industry starts to tackle aggregation
and integration with distribution/3PL operations (on a mass scale) the
robustness of enterprise serialization platforms will be tested- and many will recognize their solutions are not up to par.
2. The major players in the enterprise
serialization space will see some shakeup- with both current
players losing steam and new players entering the mix
3. The progression towards "value beyond
compliance" will be slowed by efforts to resolve issues with current
implementations
Jennason Consulting in
2019
As always Jennason
continues to provide the pharmaceutical industry with expert consulting support
and purpose-built solutions based on over 10 years of serialization and
commercial supply chain experience.
At the end of 2018
Jennason consulting engagements could generally be put into 3
categories:
1. Emerging biotech/pharma manufacturers looking
to launch products in the next 12-24 months and needing to be serialization
compliant.
2. Manufacturers who have had an ongoing
serialization project/program for 1+ years but need additional support to
resolve vendor issues to ensure compliance with DSCSA is achieved.
3. Manufacturers with an interest to extract
further value out of their serialization investments- but to do so first need
an assessment on the current state of their implementations.
Jennason looks forward
to an intriguing 2019- the consistent goal remains the same- making sure
pharmas are educated on serialization/traceability/compliance while promoting
proper use of GS1 standards to ensure best, long-term implementations.
New/Updated Solution
Offerings
Jennason Master Data
and Workflow Manager- As a company's commercial supply chain demands grow so too does the importance of
master data management. The Jennason MD&W Manager provides a
cost-effective and robust alternative to spreadsheets and manual processes. More
information
Jennason DSCSA
Verification Manager- Last fall the FDA
released guidance for Verification Systems under DSCSA.
The Jennason DSCSA Verification Manager provides a workflow for
companies to ensure compliance with all required tasks (verification,
quarantine, investigations) as well as manages required FDA and trading partner
notifications. More Information
EU FMD EMVO Gateway
Translation Tool -
Built in collaboration with Be4ward Consulting, the EMVO Gateway Translation
Tool is geared towards companies needing an immediate EU FMD compliance
solution. The Tool is capable of translating serialization data files
from packaging sites/CMOs into the EMVS format which can then be manually
uploaded via the EMVO Gateway web portal. More Information
Jennason Serialization
Test Tool- Launched over 4
years ago the Serialization Test Tool continues to be the leading off-the-shelf
testing solution specifically designed for pharma serialization
implementations. The Tool is capable of simulating common serialization
scenarios (commissioning, aggregation, shipping, end of life) and generating
the corresponding EPCIS test data. All major L4/L5 serialization platform
vendors are supported. More Information
New Service Offerings
In late 2018 Jennason
launched Jennason Design Services. The purpose of Design Services
is to support companies in need of building custom applications which
supplement or enhance their serialization and commercial supply chain
operations. Design Service engagements range from developing implementation
tools to reporting dashboards to proof of concepts for companies looking to
unlock additional value from their serialization investments.
More information
Thank you again and
look forward to hearing from you in 2019.
No comments:
Post a Comment