WMS Developed for Third Party Service Providers Serving the Pharmaceutical Supply Chain

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Datex FootPrint® WMS: Top Tier Functionality at a Fraction of the Cost of Tier 1 WMS Competitors

Built for Third Party Service Providers with Warehouse Operations

Let’s Take a Deep Dive into How the Datex Warehouse Management System Can Help Third Party Service Providers Deal with Complex Life Sciences Business Models, Regulations and Requirements

Drug manufacturers trust third party service providers including 3PLs to effectively manage, store and ship prescription drug product inventory, using economies of scale and the latest technology with the end result that drug prices can be kept under control.

  • Such as: CMO, CPO, CDMO, CRO, CTL
  • Handles the complex nature of third party operations
  • Individual, simultaneous management of multiple customer requirements:
  • Operational processes
  • Regulatory compliance
  • Quality control/quality assurance
  • Production
  • Kitting and assembly
  • Labeling
  • Documentation and reporting
  • Invoices
  • Reports
  • Billing
  • Easy to onboard new customers
  • Specific functionality for cold storage and refrigerated warehouses included
  • Inventory segregation by ownership
  • Inventory ownership transfer with complete traceability
  • Virtual inventory transfer process records “outbound shipment” of original owner inventory and “inbound receipt” for new inventory owner
  • Facilitates timely, accurate activity-based billing of value-added services

Pharmaceutical Supply Chain Challenges Increases Outsourcing to 3PLs

One of the most significant issues in driving up drug prices involves medication adherence.  When drug prices are higher, patients often cannot afford to take their prescription drugs according to doctors’ orders.  When patients do not adhere to the prescribed therapeutic plan, the prescription drugs tend to be less effective.  Approximately 30 percent of American patients do not take their prescriptions drugs according to plan because of high drug prices.  The current failure of medication adherence costs the American healthcare system up to $528 billion in terms of health consequences, illnesses and deaths.

Numerous third party logistics providers involved with specialty pharmaceutical distribution now provide additional services including:

  • Patient-centric hubs to help improve medication adherence
    • Enhanced customer service
    • Financial
  • Specialty distribution
  • Serialization services
  • Assistance with drug commercialization
  • Direct distribution
  • Wholesale distribution
  • 3PL title model
  • Flash title model
  • Order-to-cash management
  • Management of inbound logistics of raw materials and components from multiple suppliers to multiple manufacturing facilities
  • Consolidation hub management

Workflow Helps Ensure Complex Pharmaceutical Supply Chain Needs are Met.

3PLs and other third party service providers across the pharmaceutical supply chain leverage workflow-driven processes to ensure regulatory compliance, eliminate errors and streamline operations for the highest level of efficiency.

Incredibly Flexible, Configurable Third Party Services Billing Engine

  • Workflow-driven billing engine
  • User friendly billing wizard

Optional Online Customer Portal

  • Facilitates self-serve customer operations
  • Quick and easy to set up and administer
  • Provides real time visibility of inventory, lots and license plates
  • Enables assignment of shipments to new or existing delivery
  • Automates report delivery
  • Facilitates inbound and outbound order input

Have a problem? Let us show you how our 3PL WMS can solve it.

Datex FootPrint® WMS Helps Ensure Regulatory Compliance in Complex Pharmaceutical Industry

  • Electronic signature
  • Comprehensive immutable audit trail
  • Configuration of user roles and permissions ensures necessary security
  • Time-stamped records
  • Maintains electronic files that are associated to lot, serial number or item
  • Tracks DEA numbers and expiration
  • Department of Health & Human Services (HHS) Prescription Drug Marketing Act (PDMA)

Datex FootPrint® WMS Inventory Management for Pharmaceutical/Life Sciences

  • System automatically manages and decreases inventory based on the container type selected during containerization
  • System executes material transformation (from SKU to SKU) for packaging and other changes
  • Automatically advances expiration date based on the time out of optimal storage conditions
  • Bidirectional tracking of:
    • Lot
    • Expiration date
    • Serial number
  • Assigns workflow-based rules and product movement to the client or project
  • System allows multiple instances and units of measure of same product (or SKU) linked to the same or different clients, for client-owned inventory
  • Expiration lead time can be changed on specific instances of inventory
  • Raw material receipt
  • Includes logic for:
    • Fluid product tank and containers
    • Silo and fluid product

 

Datex FootPrint® WMS Offers Optional Manufacturing Execution System Module

Precision production & sample management

Equipment scheduling capability

h

Formula management including control tolerance

Batch order management including batch approval, traceability and release

Selection of materials according to FEFO/FIFO

i

Uses global and material-specific processing rules to ensure compliance with SOPs

Manages the controlled movement of batches and sub-batches

Real time verification prevents usage and consumption of expired, rejected or incorrect materials

Multi-level bill of material and job and batch costing capabilities

l

Raw material compounding

Capable of scheduling a single line manufacturing order across multiple production lines and equipment

U

Control and visibility of work-in-progress materials

Datex FootPrint® WMS Offers Optional Electronic Batch Record System

Uses batch record data to:

  • Help ensure that appropriate manufacturing procedures were followed
  • Identifies workers
  • Appropriately control material inventory
  • Verify training levels
  • Perform required quality checks
  • Validate that continuing product improvement initiatives and strategies are effective

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Datex FootPrint® WMS Quality Management Functionality

  • CAPA (Corrective & Preventative Action)
  • Training Record Manager
  • Complaint Management
  • Audit Control
  • Document Control
  • Deviation & Incident
  • Quality Audit Management

Datex FootPrint® WMS Offers Optional Pharma FDA Validation Services for Pharma and Life Sciences

  • Feature Request Specification (FRS)/Business Process Analysis (BPA)
  • Software Requirements Specification (SRS)
  • Software Design Specifications (SDS)
  • Software Development and Installation
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • User Acceptance Test (UAT)
  • Reverse Tractability Matrix (RTM)
  • Standard Operating Procedures (SOP)

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How Datex is Ideal for Pharmaceutical Industry Needs

From contract manufacturing and packaging to drug development, pharma and life sciences cold chain, Datex has the most agile warehouse management software on the market today.  Competitive with Tier 1 warehouse management systems used by information technology experts in the pharma supply chain, the Datex WMS provides real time actionable intelligence, configurable reporting and business intelligence and sophisticated functionality to help reduce warehouse and labor operating costs.

  • Specialized experience with pharma industry clients
  • White glove service with dedicated account managers and executive oversight
  • Support packages to suit the needs of your operation
  • Over 40 years of dealing with third party service providers, especially 3PLs
  • Most flexible, configurable warehouse management software on the market today
    • Reduces the need for changes to hard coding
    • Ensures customer needs and requirements can be met
  • Advanced third party billing engine ensures customers
    • Facilitates accurate, timely capture and billing
    • Easy to use billing wizard
  • Full service end-to-end solutions provider
    • Software
    • Hardware
    • Integrations
    • Business intelligence
    • Project management and implementation services
    • Variety of support plans
    • Array of specialized training
      • Online, in person and/or on site
      • Datex University
    • Additional client-only services to help optimize your technology investment such as:
      • Database tuning
      • Business process analysis
      • Mobile device management

Third Party Contract Service Providers Bring Tremendous Value to Pharmaceutical Supply Chain Businesses

Pharmaceutical companies across the supply chain, primarily drug manufacturers continue to outsource to third party contractors to gain technology, capacity and external expertise that is unavailable or inaccessible internally.  Datex FootPrint® WMS is integration-friendly, enabling the sharing of data from multiple systems for increased visibility.  This is ideal for contract manufacturing in the pharmaceutical industry as well as for contract packaging, CDMO, CRO, CTL and other outsourced service providers including those involved with cold chain logistics and warehousing.  This is especially important for specialty pharmaceuticals and life science clinical trials.

Drug prices have increased, partially due to the high costs of innovations including such root causes as cell therapy, new drug discovery and drug development, clinical trials, the scourge of counterfeit drugs and other factors.  As pharmaceutical manufacturers look for ways to curb drug prices, they have outsourced many core activities to third party providers.  Product safety, quality control and accessibility to an adequate supply of prescription drugs cannot suffer, however.

Using pharma supply chain software including warehouse management software designed to handle the complexities and regulatory compliance requirements of pharma and life sciences goods is essential to keeping costs under control.

Often, third party service providers in the life sciences industry find that they are hampered by challenges including:

  • Complex product types
  • Inventory visibility across the pharma life sciences supply chain
  • Labor and cost associated with information technology staffing needs
  • Necessity for timely, accurate track and trace of pharma goods
  • Complying with regulations such as DSCSA designed to reduce counterfeit products in the drug supply chain
  • Complex, changing business and supply chain models
  • Need to transition to digital transformation of pharmaceutical supply chain, documentation, etc.
  • Risk management issues associated in dealing with expensive, fragile goods such as biologics, gene therapies, advanced therapy requirements, etc.
  • Investment in cold chain technologies required for specialty pharmaceuticals
  • The need for streamlined manufacturing and distributing operational processes

The answer is simple, Datex.  Contact us today to find out how Datex can help.

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