Pharma and Life Science Inventory: Prescription Drugs, Animal Healthcare Products, OTC Products, Medical Equipment, Medical Devices
As pharma and life science companies endeavor to navigate FDA and state regulations for the handling and management of pharmaceutical and life sciences inventory, new sophisticated tools have become available to assist in this complicated venture. Datex FootPrint WMS is a warehouse management system (WMS) that provides the necessary security, audit trail, electronic signatures and operational tools to help companies meet these regulations and guidelines. The Datex warehouse management system includes a suite of features ideal for dealing with pharmaceutical drugs and life sciences inventory as well as software features typically found in other warehouse management features. Datex FootPrint WMS is validation ready and validation services can be included upon request.
The Datex warehouse management system supports both barcoding and RFID chips and has enhanced security roles and permissions including a full audit trail to aid in providing Chain of Custody records for controlled substances. Datex FootPrint WMS includes field level tracking of all changes that occur within the system as well as signature capture and the ability to track pharmaceutical product DEA numbers, DEA expiration, Controlled Substances Ordering System (CSOS) records and forms and handle Certificates of Analysis (COA).
Track and trace capabilities for pharmaceutical and life sciences products within Datex FootPrint WMS are superior. The system can track and trace by serial number, Lot, UPC, SKU, ingredient, batch and dose-ideal for FDA product recalls. With seamless integration to ERP, MRP, accounting systems and more, Datex FootPrint WMS can provide “one step forward and one step back” to provide full product traceability. Datex FootPrint WMS can provide traceability for both finished pharmaceutical goods and components ensuring finished formulation batch traceability.
Datex FootPrint WMS supports multiple simultaneous holds, quality control/quality assurance (QA/QC) inspections, packaging, assembly and kitting. In addition, the warehouse management system has specific functionality to monitor and record temperatures within the storage environment, essential for inventory that needs to be housed in refrigerated or freezer storage conditions. The system supports serialization and multiple allocation strategies including FIFO, FEFO, FMFO, LIFO and LMFO and can track product expiration dates and other key inventory management details.
Security provisions for dealing with medical devices and pharmaceutical drug products within the Datex warehouse management system are exceptional. Users can be restricted based upon roles and other factors and disallowed from viewing specific data, reports and functionality. The system records all activity and provides a full audit trail, ideal for complying with FDA regulations such as FDA 21 CFR Part 11. The audit trail is especially useful in providing documentation needed for Chain of Custody. The Datex FootPrint WMS electronic data integrity system contains security controls for workflow, data and electronic signatures to ensure that data is complete, accurate, original and contemporaneous. Inventory can be restricted to specific zones or temperature controlled locations to ensure product integrity.
Datex FootPrint WMS for pharmaceutical and medical device inventory includes the ability to attach documentation to inventory records including certificates, inspection reports, photos, files and more. Detailed records regarding inventory can be maintained within the system to ensure the proper placement of all necessary documentation for FDA compliance such as Certificates of Analysis (COA), Controlled Substance Ordering System (CSOS) and other records.
Datex FootPrint WMS was developed using easy to configure workflows rather than static hard coding that is costly and time consuming to change. By relying on workflows to form the building blocks to power business processes, your organization will be more agile, flexible and responsive to meet client expectations and regulatory requirements. Using a warehouse management system (WMS) that provides the transparency, information visibility, inventory control and security needed will enable your company to meet FDA regulatory requirements with complete accuracy and less labor. Datex FootPrint WMS was built to handle highly complicated processes with numerous steps.
One of the hallmarks of Datex FootPrint WMS is the ability to easily create customized reports by simply “dragging and dropping” fields into the format of choice. Users can create reports to suit a variety of needs or select from a myriad of standard reports already built within the warehouse management system. Reports can be configured to document proof of control or compliance and provide the necessary level of detail for government reporting. Reports include real time information and drill down details. Users can create graphs, charts, maps and other diagrams. Users can subscribe to reports, share with other users and make reports available via an optional web portal.
Datex FootPrint WMS for Pharmaceutical and Life Sciences Product Manufacturers
Pharmaceutical manufacturers have specialized needs in properly managing and storing drug and life sciences product inventory. Whether dealing with storing or manufacturing pharmaceutical components or finished goods, Datex FootPrint WMS can provide the tools needed to improve business performance.
Datex FootPrint WMS can track raw materials, pharmaceutical components and packaging and report on project costs including labor and overhead. As temperature and environmental conditions can affect pharmaceutical product manufacturing, Datex FootPrint WMS includes specific temperature related functionality. Within the warehouse and pharmaceutical manufacturing facilities, the Datex warehouse management system can associate temperature categories to specific locations. Products can be restricted to specific locations or temperature categories including refrigerated, freezer and ambient zones. Notification can be made automatically to users when inventory is located outside the restricted area.
In addition, the Datex warehouse management system helps ensure that drug inventory is properly received and stored into the proper environmental conditions. Ideal when dealing with pharmaceutical or life science inventory that requires refrigerated or freezer storage, Datex FootPrint WMS recognizes and tracks the time in ambient conditions and can send alerts to system users in order to prevent inventory waste, damage or spoilage.
The Datex WMS for pharmaceutical products can also aid in quality assurance and quality control processes such as pharmaceutical component testing, sample inspection, quarantine and pharmaceutical product holds. Pharmaceutical and life science products whether components or finished goods can be tested then re-tested, sampled all according to manufacturing requirements. Individual samples can be taken during the manufacturing process and tracked. Datex FootPrint WMS can handle multiple simultaneous holds with automated scheduled releases. The warehouse management system facilitates and tracks pharmaceutical product inspections and also handles Certificates of Analysis (COA).
Multiple batches of pharmaceutical product can be produced against work orders then sales orders can be issued for specific products. All pharmaceutical products and pharmaceutical components can be tracked using the Datex WMS. Datex FootPrint WMS also helps pharmaceutical manufacturers by tracking waste.
From pharmaceutical and life science product manufacture to storage, Datex FootPrint WMS has the functionality to make a major impact on the bottom line of operations, boosting accuracy, productivity and efficiency.
Pharmaceutical and Medical Device Product Serialization
Pharmaceutical product serialization involves generating unique serial numbers for products so that the identifications can be maintained to provide both visibility and complete traceability within the entire supply chain. To do this requires the collaboration of supply chain partners.
Pharma serialization guidelines vary from country to country but all have the same goal, to curb counterfeiting and ensure patient safety. Serialization regulations tend to be built around GS1 standards, creating a basis for similarity.
The Datex system can generate Serialized Global Trade Identification Number (SGTIN) labels with 2D barcode and maintains an association for the Finished Goods Item (FG) and Global Trade Identification Number (GTIN).
Why pharmaceutical product serialization is needed:
- Combats counterfeit of pharmaceutical products
- Helps prevent unauthorized distribution of branded pharmaceutical products
- Reduces the risk of having incorrect pharma products being put into distribution
- Provides a means of tracing pharmaceutical products throughout the supply chain
- Facilitates product recalls
Benefits of Pharmaceutical Product Serialization:
- Brand Protection of Pharmaceuticals and Medical Devices
- Enhanced Pharmaceutical Product Control
- Improved Pharma Product Pricing Accuracy
- Greater Supply Chain Efficiency for Medical Devices and Drug Products
- Reduced Risk of Counterfeit Drugs
Datex FootPrint WMS for Serialization and Product Authenticity
Datex FootPrint WMS supports product serialization encoding requirements for countries outside the United States and has been implemented throughout North America, Latin America and the Middle East. The Datex warehouse management system has been used for finished serialized goods distributed to drug wholesalers. It can be used to receive information from packaging and record Global Trade Item Number (GTIN), serial number (between 6 and 20 alphanumeric characters, alphanumeric Lot code, and expiration date encoded in a GS1 Datamatrix symbol.
The Datex solution supports 96-bit RFID encoding for serialized goods. Datex is now a proud partner to an industry leader in RFID technology solutions and can provide an end-to-end solution for data collection and chain of custody using the latest RFID solutions.
Datex FootPrint WMS can support multiple, different serial number formats within the same system. The software solution includes a barcode parsing tool that allows users to scan any barcode of any length encompassing alpha numeric characters in order to decipher the Lot code, expiration date, production date or serial number. This includes but is not limited to the GTIN code or any barcode symbology.
The barcode parser provides users with the ability to use a single barcode to define product details such as: SKU, weight, license plate, serial number, lot, expiration dates, etc.
This allows receiving operations to perform a single scan and have all pertinent information populate automatically as opposed to filling them out one at a time. This simple ability ensures tremendous accuracy, labor and time savings and a smoother operation
Datex FootPrint WMS Helps Meet the Needs of FDA 21 CFR Part 11
To help meet the needs of 21 CFR Part 11 for pharmaceutical and medical device products, Datex FootPrint WMS includes a comprehensive audit trail showing detailed information by user. The system date and time stamps every action whenever an electronic record is created modified or deleted and cannot be edited. The system date and time for audit trails is generated from a single secure reliable source. Once an ID is attached to an electronic record, it cannot be reassigned or deleted but can be deactivated. Access to the audit trail is severely restricted and is permissions based using role based security that only a systems administrator can access and alter. System access is automatically restricted to authorized individuals using a unique user ID in combination with a password.
Datex FootPrint WMS includes added security provisions to protect data integrity. Passwords must be changed at established intervals. Additional controls are in place to safeguard the system from deliberate or inadvertent alteration or destruction. Datex FootPrint WMS also includes the means to prevent, detect and mitigate the harmful effects of viruses, worms and harmful code.
System documentation of Datex FootPrint WMS details procedures for establishing new user accounts and associated authorities; retiring user accounts and preventing duplicate user IDs. Documented procedures are provided to instruct system administrators how to ensure that access to system records maintenance by system or computer support personnel is formally managed and an audit trail recorded.
Another way the Datex warehouse management system aids in meeting the needs of FDA 21 CFR Part 11 involves the incorporation of checks within the system in order to determine the validity of the source of data input to ensure that it does not allow “write” access for shared groups, guests or similar accounts. Changes are tracked back to system specific accounts, privileges and roles within the system audit trail. The Datex warehouse management system supports the timely retrieval of archived data and verified routine back-up and recovery.
FDA 21 CFR Part 11 requires top security. For security purposes, the system automatically logs users off whenever there is a specified period of inactivity. For records inspection, the Datex warehouse management system is able to display and print complete, accurate copies of records. Datex can provide a suite of Managed Services to ensure that the system is backed up and records retained for potential retrieval at will for the appropriate retention period. Datex provides system validation services to ensure system reliability, accuracy, performance consistency and the ability to discern invalid and altered records. Datex FootPrint WMS supports high availability and uses Microsoft Workflow Foundation to create automated operational system checks to enforce permitted sequencing of steps and events.
Datex FootPrint WMS provides an audit trail so that all changes are tracked throughout the system. This information can be provided easily and traced by user to allow full visibility. In addition, reports can be generated to summarize or detail the information contained in the audit trail.
Datex Warehouse Management System Provides Track and Trace
Datex FootPrint WMS provides complete Lot track and trace down to the component level, ideal for product recalls.
The Datex warehouse management system provides full traceability by Lot, serial number, SKU, UPC, component, batch, package or vial and can help meet ePedigree requirements.
The term “ePedigree “, also known as electronic pedigree or e-pedigree simply refers to an electronic document that provides detailed information on the history of a particular batch of a drug or pharmaceutical product. This history includes a statement of origin identifying each prior sale, purchase or trade of a drug and includes the date of transaction and names and addresses of all parties to the transactions. Primarily developed to protect consumers from counterfeit or contaminated drugs, ePedigree is an essential tool in pharmaceutical product safety.
EPCglobal, the organization established to achieve worldwide adoption and standardization of Electronic Product Code (EPC) technology ratified the Pedigree Standard in 2007 specifying an XML description of the life history of a product across the complicated supply chain. Currently most US states have enacted some type of pedigree requirement. The basic elements of an original ePedigree are: drug Lot, drug potency, drug expiration, National Drug Code and Electronic Product Code, drug manufacturer; drug distributor, wholesaler or pharmacy; unique identifier of the saleable unit.
As the drug product moves through the supply chain, each company is required to carry forward all previous ePedigree information to allow full traceability. This is the means for providing full track and trace of each drug product from origin straight through to the consumer. Each product batch must remain completely unique and fully traceable without loss or duplication of information. An individual product at the smallest dispensable container level must be tracked and traced from each raw and package material that is incorporated into the production through any bulk cases, cartons, pallets, totes or shipping containers used for its transport and location information encoded each time the product changes locations.
Pharmaceutical and life sciences companies involved with manufacturing, distributing, warehousing or dispensing drugs or devices which are pre-filled with drugs are affected by numerous regulations and guidelines including but not limited to:
- U.S. FDA serialization guidelines
- GS1 healthcare serialization standards
- California ePedigree law
- China’s SFDA serialization requirement
- Turkey’s serialization requirements
Compliance with US state pedigree laws is mandatory. Failure to comply may result in administrative fines and other actions.
Datex FootPrint WMS includes ability to track and trace by Lot, serial number, component, SKU, UPC, batch, package or vial. The Datex WMS can trace Lot numbers back to suppliers through clients by Lot or batch or through outsourcers. In addition, the Datex warehouse management system can manage the traceability of compounding facilities and can track DEA numbers and DEA expiration. The Datex system can capture and track expiration date and test certifications and retain documentation within system inventory records for safekeeping. Datex FootPrint WMS can house photos of damaged pharmaceutical products in inventory records, as well as inspection records and certifications and can track and locate CSOS records and forms.
The Datex WMS can also produce reports on accounts with nearly or already expired DEA numbers as well as Lot status change reports showing release Lot, quarantined and more. Customized reports can be created by “dragging and dropping” fields into the format of choice making it easy to create reports for exactly the information needed. Datex FootPrint WMS includes the ability to subscribe to reports to ensure smooth, continuous automatic delivery.
Key Inventory Management Features of Datex FootPrint WMS for Life Sciences
- Validation ready; validation services can be provided upon request
- Full audit trail to provide Chain of Custody records for controlled substances
- Field level security of all changes within the system
- Signature capture
- Enhanced security and permissions
- Secondary packaging and kitting
- Pharmaceutical sample management
- Handles Certificate of Analysis (COA)
- Holds, quarantines, sampling and inspections
- Multiple simultaneous holds with automated scheduled releases
- Generates customer specific quarantine labels
- Can change inventory status by Lot, location or license plate
- Can report on accounts with nearly or already expired DEA numbers
- Can track and locate Controlled Substance Ordering System (CSOS) records and forms
- Trace Lot numbers back to suppliers through clients by Lot or batch or through outsourcers
- Putaway processes with location constraints for controlled substances or temperature controlled zones
- Multi-dimensional inventory capabilities
- Multi-bin tracking
- Track items across multiple locations
- Recall and return administration
- Change control and security
- Outdated drug disposal
- Lot/batch/expiry date management
- Automated replenishment
- Controlled process to flag inventory that is damaged, expired or recalled
- Supports multiple packaging levels: pallets, case, each, dose, batch
- Support multiple units of measure: lbs, kg, oz; g, L, mL
- Can handle consigned medical equipment and supplies inventory
- EDI enabled
- Can be integrated with other systems
Datex FootPrint WMS Helps Meet Drug Pedigree Messaging Standards (DPMS)
In order to meet the needs of DPMS pedigree to maintain the authenticity of the pharmaceutical goods and/or components, Datex FootPrint WMS has the capability of maintaining electronic files associated to the item, Lot or serial number. This can be generated on demand using the Microsoft Windows Workflow Foundation that is embedded within Datex FootPrint WMS. This information can be used downstream to allow each shipping case to be transmitted electronically or printed on demand.
In addition, Datex FootPrint WMS can be integrated with a DPMS e-Pedigree system to produce pedigree for each shipping case and transmitted in a DPMS pedigree envelope file.
Datex FootPrint WMS can receive and process DPMS pedigree, the mechanism used to maintain the authenticity of the pharmaceutical goods or components. The Datex warehouse management solution has the capability of maintaining electronic files associated to the item, Lot or serial number and can be generated on demand using the workflow embedded within the WMS software.
Datex Warehouse Management System Can Provide Supplier Collaboration Tools
Datex FootPrint WMS offers an optional procurement module including a supplier management portal that will allow for remote management of serialized inventory, purchase order management, inbound receipt management and outbound shipping management. The remote portal also allows for visibility and maintenance of product master file details.
Datex FootPrint WMS Can Produce Healthcare Distribution Management Association (HDMA) Labels
Datex FootPrint WMS can produce HDMA labels that include name, expiration date, NOC, Lot number, quantity, manufactured by, distributed by, Global Trade Item Number (GTIN), GS1-128 and serial number if applicable.
Navigating Pharma Logistics
Pharmaceutical producers combine ingredients precisely, under specific conditions, while negotiating a maze of stringent regulations and quality controls. Companies that move or store pharmaceutical products must meet similar demands. Many drugs are highly sensitive to temperature; some are extremely valuable; and all are subject to a complex array of government regulations. In the pharmaceutical supply chain, every detail counts.
3PL execs assess global business conditions, highlight healthcare’s potential
In conjunction with the Council of Supply Chain Management Professionals’ annual symposium (Atlanta, Sept. 30-Oct. 3), the 19th Annual Survey of Third-Party Logistics Providers was delivered. The survey conducted by Dr. Robert Lieb, a business school professor at Northeastern University, and Joe Gallick, SVP sales for Penske Logistics (Reading, PA)—and with funding from Penske—polled 31 “large” 3PLs in North America, Europe and Asia-Pacific. Most of the study looks at overall business conditions and forecasts; this year, a part of the study was dedicated specifically to healthcare.
Emerging markets influence changes in global pharma distribution
As pharmaceutical companies rapidly expand into emerging markets abroad, observers say they are running into complex challenges. Distribution issues are arising due to increasing security concerns, country-specific regulatory compliance, and limited scope of infrastructure. But this has not stopped third-party logistics providers (3PLs) from developing a range of strategies and services to ensure Rx drugs are delivered safely and cost-effectively.
Tips For Selecting A 3PL For A Life Sciences Supply Chain
Many life sciences companies are outsourcing their supply chains to 3PL (third party logistics) providers. It seems that everyone is getting into the 3PL business from public warehousing firms to trucking companies. When a life sciences company decides to outsource its supply chain, it needs to ensure that the 3PL understands the complexities of the business. Yes, life sciences is different from manufacturing and high tech. When selecting a 3PL, it is important to understand if the 3PL is committed to the life sciences vertical market and has the experience in managing the life sciences supply chain. Many 3PLs become extensions of the life sciences company’s staff. Here are some general questions that need to be considered when evaluating a 3PL for the life sciences supply chain. How was the 3PL formed? Did the 3PL acquire a smaller life science logistics company or are they part of a larger drug wholesaler? How many individuals on the staff have deep experience in the life sciences industry? Did they previously work for a wholesaler or a pharma company?