Valued Jennason Customers and Colleagues-
As we enter a critical phase in pharma serialization, I wanted to provide a few
updates on Jennason’s consulting services and solution offerings.
The theme over the coming months and into 2025 is “for
the first time” as the pharma industry enters uncharted territory with the
final milestone of DSCSA set to go into effect in November.
To put it simply- “for the first time” C-level
executives will start getting phone calls about product supply distributions,
and the associated financial consequences, due to serialization issues. The companies which recognize and address
this momentous shift will be best positioned to avoid these operational and
financial risks.
Towards that end, we are excited to announce the upcoming
release of Jennason DASH. DASH is
positioned to be an indispensable tool for a manufacturer’s daily management of DSCSA operations. More information can
be found below in the ‘Solution Updates’ section.
State of the Industry:
- For the past 10+ years the industry has worked to implement serialization systems and processes, but “for the first time” are operating in a mode where these systems and processes MUST work in order to avoid supply distribution. The function, usability and customer support of serialization systems is being tested. (and the results are often not positive)
- State
agencies are widely distributing targeted DSCSA audits. This means many companies “for the first
time” have to show evidence of documented DSCSA processes including
product verifications/requests for information, suspect & illegitimate
product handling, waivers & exceptions management and authorized
trading partner management.
- The industry’s lack of standardization and progress towards implementing efficient DSCSA exception handling means companies “for the first time” will be faced with resourcing needs to manage DSCSA operations on a daily basis that exceeds internal capacity.
Consulting Updates and Outlook
Jennason consulting services continue to focus in three main areas:
- Supporting
manufacturers in development of their daily DSCSA operations management
procedures. Jennason clients are on
the leading edge of exception identification and resolution- ensuring the
risk and financial impact due to supply disruption (rejected/returned
shipments) are minimized. Two key
lessons learned:
- Your serialization vendor plays a major role in your ability to define and execute efficient DSCSA daily operations. Many companies are now feeling the pain as vendor capabilities fall short in three main areas: System usability, access to data and customer support. With the expectation that DSCSA exceptions are resolved as soon as possible, having to wait a week for your vendor’s customer support to respond is unsustainable.
- Relying on human/manual effort alone cannot scale to the levels of efficiency most manufacturers need. Managing and resolving exceptions through technology is the only feasible answer. Jennason has the solutions. (See more below)
- Executing
DSCSA compliance assessments including mock audits, simulation sessions,
compliance gap identification and recommended mitigations. Jennason has developed a 40-point DSCSA
compliance checklist for manufacturers to ensure line-by-line compliance
with all applicable requirements.
Additionally, Jennason has authored SOP templates that are
leveraged by clients to quickly mitigate documentation gaps. Jennason clients who have gone through
a DSCSA compliance assessment are positioned to confidently respond to
audits.
- Supporting
emerging pharma and biotechs as part of commercial launch activities.
Companies who are preparing for their first commercial product will now be
launching into an environment that requires full serialization compliance
from 'Day 1'. No longer can
companies only plan to have serialization systems and
packaging/distribution connections in place for launch, now all process
documentation must be effective as well as connectivity with all
downstream customers. The result has been a notable shift during vendor selection evaluations- as the
focus is now on system usability, exceptions management and customer
support. Jennason continues to help
pre-commercial organizations through serialization education, planning,
vendor selection and implementation.
Solution Updates
Jennason continues to provide leading implementation aides and operational
solutions to the industry. The
Serialization Test Tool maintains its position as the industry’s only
serialization-specific test data simulator- capable of simulating batch
packaging, shipments/receipts and end of life scenarios without the costly
dependencies on packaging, distribution and trading partners. (https://jennason.com/solutions)
We are also excited to announce the launch of the most
comprehensive and integral solution that Jennason has brought to market to
date: Jennason DASH
Jennason DASH fills a significant gap in providing real-time visibility into daily DSCSA compliance operations. DASH serves as the centralized point for manufacturers to monitor business critical serialization activities including:
- Real-time reconciliation monitoring: DASH is the industry’s only solution which incorporates batch and shipment source data from electronic batch records, ERP and packaging/ distribution partners and compares against your serialization data. With DASH, companies identify mismatches between source and serialization data for every batch and every outbound shipment to customers- including reconciliation of each shipment line item to ensure the associated DSCSA T2 reflects the right product, lot, expiry and quantity of SNs. Customers are immediately notified of reconciliation issues- often prior to the physical product arriving at the customer- thus giving DASH users valuable time to resolve exceptions before it impacts product supply.
- Exceptions Management: Reconciliation failures as well as exceptions communicated by trading partners are managed by DASH through to resolution. DASH directs users through the necessary resolution steps based on the nature of the exception and the trading partner(s) involved. Moreover, when integrated with select serialization vendors, DASH can automate resolution actions including data corrections.
- Inquiry and Investigation Record Management: DASH provides a repository and workflows for carrying out required DSCSA processes including product verifications, requests for information/product tracing requests and trading partner/FDA notifications. Product verifications and product tracing requests can be performed directly in DASH, including the gathering of required response evidence and the automation of response communications back to the requestor. When needed, DASH also provides workflows for carrying out suspect product investigations and associated illegitimate product actions including Form 3911 generation and the retention of sampling and disposition records.
- Supply and Trading Partner Management: DASH allows companies to manage the onboarding and ongoing support of supply partners (Packaging/CMO/Distribution/3PL) and trading partners. These features integrate with Jennason’s Pharma CollabNet Master Data repository which maintains location and contact master data for thousands of industry entities. Direct access to Jennason Pharma CollabNet eliminates the need for inefficient master data exchange and streamlines the onboarding processes.
As always please feel free to reach out anytime with questions/comments. Have a great end to 2024!!
Scott Pugh
Principal
No comments:
Post a Comment