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Proprietary and confidential do
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Regulation
Draft
Serialization of pharmaceuticals
D
2010
2011
2012
2013
2014
2015
2016
2017
2018
D
2019
D
2020
2021
Requirements
High level regulatory requirements
and interpretation
Sufficient time to implement
Standards vs. proprietary
Barcodes
Encoded data
Data exchange
Cross-functional Teams
Functions
Operations: Manufacturing,
distribution, TPM, CMO, 3PL
Regulatory
Business operations
Supply chain
LOCAL APPROACH
Everyone talks to everyone in various localized formats
Communication changes from simple Batch to complex
and large amounts of information hierarchies
Data management will have to become a core
competency for all groups involved
Disparate hardware systems require more attention
BIG Data
50,000 units /batch
50 batches per year
PER YEAR
50 batch records
50 shipment notices
PER WITH SERIALIZATION
50 batch records
500 pallet records
50 shipment notices
2,500,000 serialized unit records
Global
Global network of sites
and suppliers
Distributed, de-centralized
teams, time zones
Language translation
Mergers & acquisitions
New product introduction
Shared packs and over-labeling
Recommendation
Design and build for
flexibility and scalability
Modularize functionality
Partnership vs. vendor
Standards, stanDARDS,
STANDARDS!
Evolve with requirements
Strong governance