Pharmaceutical Warehouse Management System
Documentation & Compliance with Federal Regulations (FDA)
From Los Angeles to New York, across the life science supply chain, pharmaceutical companies are challenged every day to meet a complex maze of regulations, ensure quality control and manage costs. With FDA regulations including FDA 21 CFR Part 11 and the FDA Drug Supply Chain Security Act (DSCSA), the pharmaceutical industry needs feature-rich, adaptable inventory and warehouse management solutions to meet these pressing needs. Datex Pharmaceutical Warehouse Management Software includes the features needed to maintain documentation and help ensure compliance with FDA, EU and other regulatory systems.
- Tracks DEA expiration
- Tracks DEA numbers
More Details
- S. Department of Health & Human Services (HHS) Prescription Drug Marketing Act (PDMA)
- FDA Current Good Manufacturing Product (CGMP)
- Physician Payments Sunshine Act -Section 6002 of the Patient Protection & Affordable Care Act (PPACA)
- System validation
- Chain of Custody
- Handles Drug Enforcement Administration (DEA) Controlled Substances Ordering System (CSOS) records & forms
- Maintains electronic files associated to item, lot or serial number
- Can be integrated with DPMS e-pedigree system
- Produce pedigree for each shipping case
- Transmit in DPMS pedigree envelope file
Validation Ready Pharmaceutical Warehouse Management System (WMS)
Datex validation service documentation includes:
- 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)
Track and Trace and Traceability in Datex Pharmaceutical WMS
Throughout the pharmaceutical supply chain from life science manufacturing facilities and third party logistics operations to those handling wholesale distribution, being able to track and trace goods by expiration dates and handle lot tracking is mission critical. In the event of product recalls, having access to real time, accurate data helps to reduce the risk of illness and death.
- Batch traceability
- Expiry dates
- Captures & tracks expiration date & test certifications
- Capable of managing traceability of compounding facilities
More Details
- 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
Serialization – Pharmaceutical Warehouse Management System
- Supports serialization encoding requirements for countries outside the U.S.
- Supports, multiple different serial number formats within same system
- Supports 96-bit RFID encoding for serialized goods
- Can receive data from packaging & record:
- Global Trade Item Number (GTIN)
- Serial number (between 6 & 20 characters)
- Alphanumeric lot code
- Expiration date encoded in GS1 Datamatrix symbol
Aggregation in Datex Pharma WMS
- Records & stores serial numbers & their relationship to serialized containers
- Lowest unit of measure would have true serial number
- Every level up would be a license plate for an infinite number of level
- Allows previously aggregated & seals shipper cases to be opened, items removed & aggregation updated using simple package conversion task
More Details
- Supports manually adjusting shipper case aggregation
- Allows users to manually build aggregation of items into shipper cases & shipper cases into pallets
- Recorded aggregation information can be transmitted as Advanced Shipping Notices (ASNs)
- Able to “drill down” for more details in reports
- Able to provide & use IARW reports
Quality Assurance/Quality Control Features of Datex WMS
Warehouse management software designed to automate processes including those involving documentation for Chain of Custody, quality control, handling of controlled substances and temperature controlled inventory can aid in eliminating human error and reduce the risk of damages as well as provide other benefits.
- Inspection
- Testing
- Quarantine
- Holds
More Details
- Configurable workflow-based processes ensure warehouse workers complete QA/QC processes properly in the necessary order
- Inspection workflow dependent on product type
- Controlled vs. non-controlled
- Capable of multiple simultaneous holds with automated scheduled releases
- Handles Certificates of Analysis (COA)
- Inspection workflow dependent on product type
- Can change inventory status by
- Lot
- Location
- License plate
Pharmaceutical WMS Inventory Management
With the rise of biologics, pharmaceutical companies have new concerns for product safety, specifically proper handling and inventory storage in refrigerated and other cold storage conditions. This typically necessitates warehouse management software that can enable the temperature monitoring of cold storage systems as well as other inventory management processes and details.
- Multiple allocation strategies: FIFO, FEFO, FMFO, LIFO, LMFO
- Supports multiple packaging levels
- Multiple units of measure supported
- Provides transaction time stamps
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Security Features of Datex Pharmaceutical WMS
- Immutable audit trail
- Electronic signatures
- Role-based security and permissions
- Field-level tracking of all system changes
- System restricts ability to change inventory status (damages)
Pharmaceutical Sample Management
One of the most complex issues in the life sciences industry is pharmaceutical sample management. Pharmaceutical companies benefit from relying on advanced warehouse management software that includes the capabilities to help ensure adherence to tight controls, labeling, processing and monitoring. The workflow-based Datex Pharmaceutical WMS automates processes to help ensure that warehouse workers do not miss steps in required processes and meet regulatory requirements.
- Description of material by pallet, case, tray and dose
- Different SKU configuration
- Certificate of Acceptance tracking
- Electronic signature
More Details
- Check of state regulations
- System manages limitations:
- Doctor
- Manufacturer representatives
- Verifies credentials and classification for eligibility requirements
- Proof of delivery
- Notification of Certificate of Acceptance
- Management of specific shipping requirements
- Workflow-based cartonization and shipping management
- Management of revision-controlled marketing materials
- Validation for HCP (Healthcare Practitioner) and HCO (Healthcare Organizations) via integration with MedPro or similar system
Microsoft-Based WMS with Familiar User Interface
People fear change. The Datex warehouse management system WMS builds on a familiar user interface that looks and feels like software most people use regularly. Purposely designed with familiarity in mind, our software users tend to become comfortable using our software quickly, improving software adoption rates.
“Datex WMS software is easy to learn. With the high turnover rate in this industry and our reliance on seasonal workers, it is especially important to us that we can train workers quickly to use our warehouse management system."
-Third Party Logistics Operations Director, CA
WMS Seamless Integration with Other Business Systems
- ASN and EDI ready
-
Integrates with:
- Payment gateways
- ERP
More Details
- DMR HCP Solutions (Healthcare License Verification)
- State portals
- Aggregate Spend Solutions
- Federal Open Payment and State Regulations
- Healthcare Licensing Database Solutions (MedPro or similar)
- DPMS e-pedigree system
- Accounting & financial systems
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- MRP
- E-commerce
- Shipping systems
- Shipping carriers
- TMS
- Material handling systems
And more
Reporting Capabilities of Datex Pharma WMS:
- Users can create customized reports by “dragging & dropping” fields into the format of their choice
- FDA
- Exception reports
- Data resolution process reporting
- Process returns report
- Healthcare practitioner inclusion and exclusion report
- Generate reports for accounts with nearly or already expired DEA numbers
- Lot status change report shows release lot, quarantines and more available
Pharmaceutical Inventory Labels
HDMA labels with the following information:
- Name
- Expiration date
- NDC
- Lot number
- Quantity
- Manufactured by
- Distributed by
- Global Trade Item Number (GTIN)
- GS1-128
- Serial number
Capable of printing labels using 3rd party application including:
- Quarantine labels
- Customer-specific labels
WMS Document and File Management
- Capable of attaching any file to inventory records including:
- Photos
- Video
- Certifications
- Inspection records
- Store photos of damaged product in inventory records
- Track and locate CSOS records and forms
Pharmaceutical WMS User-Specific Notification and Alerts
- Set up alerts based on expirations of
- Account DEA number
- Account DEA number nearing expiration
- Customize by user and role
Additional Resources:
- Centers for Medicare and Medicaid Services Open Payments
- DEA: Inventory Requirements for Controlled Substances
- DEA: Recordkeeping Requirements for Controlled Substances
Learn more about industry-specific software for your pharmaceutical business:
WAREHOUSE / DISTRIBUTOR
Real-time warehouse management software for the pharma supply chain.
THIRD PARTY LOGISTICS
Third Party WMS manages inventory of multiple pharmaceutical companies.
MANUFACTURER
Pharmaceutical Companies Use Datex WMS for Quality Control.
HEALTHCARE
Datex Healthcare WMS will reduce costs, boost labor productivity and ensure regulatory compliance.
CONTRACT MANUFACTURER / packager
Multi-client inventory management WMS for contract manufacturing companies.
SPECIALTY PHARMACEUTICAL DISTRIBUTION
Ideal for the Specialty Pharmaceutical Distribution Industry.