Datex Pharmaceutical & Life Sciences Manufacturing Software

Pharmaceutical Companies Use Datex WMS for Quality Control
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Designed to facilitate, document and monitor regulatory compliance, Datex software for the pharmaceutical and life sciences industry relies on our workflow engine.  Datex workflow customizes and automates operational processes to help ensure maximum efficiency, workforce productivity, process compliance and accuracy.  Our software includes essential features such as track and trace, notifications to monitor such factors as shelf life, lot traceability, expiration dates & status changes, intensive inventory controls and customizable quality controls processes.

Pharmaceutical and Life Sciences Manufacturing Processes

Key to the pharmaceutical industry is its ability to ensure regulatory compliance, ensure consistent quality control and effective production management to keep supply chain costs under control.  Use of pharmaceutical manufacturing software helps to ensure proper quality management of pharmaceuticals, medical devices, medical products and life science goods.

Production, Planning and Scheduling

  • Handles planned as well as Just-in-Time (JIT) production
  • Handles master orders which contain multiple orders going to differing locations
  • Manufacturing feedback provided by staging area
  • Build production orders
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  • Maintains management controls and visibility throughout manufacturing process
  • Set up rules for production & storage area requirements
  • Optimizes manufacturing process efficiencies
    • Minimizes production down time
    • Handles multiple product lines
    • Minimizes waste
    • Helps to improve delivery times
    • Aids in streamlining production scheduling
    • Improves control over yield, scrap and rework metrics
  • Provides visibility of process manufacturing operations
  • Can specify production lines
  • Determines preparation staging areas for raw materials
  • User-friendly color-coded scheduler
  • Tracks work-in-progress
  • Capable of handling raw material substitutions
  • Automates Bill of Material creation
  • Keeps track of & balances during production:
    • Raw materials
    • Components
    • Ingredients
    • Scrap
    • Finished goods
    • Batch control
    • Expiry dates

Life Sciences Production Management

  • Manages record keeping for FDA compliance
  • Change control
  • Handles multiple package changes
  • Able to customize product conversions by component
  • Inventory claim feature
  • Handles owner transfer seamlessly
  • Link product type to specific equipment

Special Manufacturing Features:

System automatically advances product expiration date based upon the time out of the optimal storage
conditions (for example refrigeration)

Handles material transformation:

For example:  SKU to SKU for packaging changes

Quality Assurance/Quality Control (QA/QC) Processes

Manufacturing operations for pharmaceuticals, medical devices and other life sciences and medical products require constant vigilance to ensure product quality.  Having cutting edge tools including manufacturing software that is workflow-based can help reduce or eliminate human error, ensure that all quality control processes are followed properly and facilitate product recall management.

  • Workflow-based quality inspections
  • Change control
  • Workflow-based management of approval process
  • Quarantines
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  • Schedules inspections
    • Visual product inspection
    • Testing
    • Re-inspections
  • Holds
  • Product recall management
  • Lot and expiration date configurable rules including FEFO, FIFO, LIFO and others, food and pharma grade
  • GS1 barcode automation for NDC, lot and more
  • Track & trace by serial number, lot, UPC, SKU, component, batch, package or vial
  • Traceability of components and finished goods
  • Tracks orders based on expiration date, serial number & batch number tracking
  • Tracks samples pulled from manufacturing for testing & use in laboratories
  • Traces lot numbers:
    • Back to suppliers
    • Through clients by lot or batch
    • Through outsourcers

Inventory Management

  • Temperature capture
  • Restriction of inventory to specific zones
  • Enables inventory to be stored in a primary or secondary temperature zone
  • Variable units of measure
  • Blind and bulk receiving
  • Multiple allocation strategies supported: FEFO, FIFO, FMFO, LIFO, LEFO, LMFO & more
  • RF and RFID-enabled

Record-keeping

Whether you are a Compliance Manager, Operations Director or CIO, you will appreciate how Datex Pharmaceutical Manufacturing Software makes it easy to record, document and monitor regulatory compliance.

  • Comprehensive audit trail
  • System records:
    • Dates and times
    • Equipment used
    • Rework
    • Electronic signatures

Alerts and Notifications

  • System advises users of status changes & conditions
  • Customize alerts based on user role & need

Integrations

From enterprise applications such as ERP solutions to material handling and payroll and human resources systems, Datex Pharmaceutical Manufacturing Software can be integrated to enable the seamless flow of real time information across your business and the supply chain.  Our software integrates with:

  • Accounting software
  • ERP software
  • Financial management solutions
  • Material handling solutions
  • Shipping carriers
  • Transportation management systems
  • And much more
  • E-commerce

Learn more about industry-specific software for your pharmaceutical business: 

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