Pharmaceutical and Life Science Inventory
Medical equipment. Prescription drugs. OTC products. Animal healthcare products. Medical devices.
As pharma and life science companies endeavor to navigate FDA and state regulations for the handling and management of 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 meet these guidelines.
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.
Track and trace capabilities within Datex FootPrint WMS can provide you with real time information to react more quickly and strategically. 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 goods and components ensuring finished formulation batch traceability
Security provisions 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 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 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.
One of the hallmarks of Datex FootPrint WMS is the ability to readily 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 supports multiple simultaneous holds, quality control/quality assurance inspections, packaging, assembly and kitting. In addition, the warehouse management system has specific functionality to monitor and record temperatures within the storage environment. 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.
Key Inventory Management Features
of Datex FootPrint WMS for Life Sciences
- Secondary packaging and kitting
- Bill of materials
- Multi-dimensional inventory capabilities
- Multi-bin tracking
- Track items across multiple locations
- Quick accurate order fulfillment
- Recall and return administration
- Outdated drug disposal
- Complete management reporting
- Lot/batch/expiry date management
- Ability to customize services
- Automated replenishment
- Controlled storage
- Drug product receiving
- Service level monitoring and product visibility
What is workflow?
Workflow is a set of activities grouped together using logic and decision making to form a process. Datex FootPrint WMS uses workflows to build customized processes throughout warehouse operations to ensure proper inventory handling to meet industry, regulatory and customer requirements.
Using workflow rather than static hard coding for a pharmaceutical inventory management system provides distinct advantages. Specific inventory management processes such as quality assurance inspections, authentication and other critical processes for handling pharmaceutical product inventory. Processes are first mapped out on diagrams to ensure that all steps in the process are included. Decision points, logic and responses are also mapped out to show a series of outcomes based on “if then” statements. By using customizable workflows, Datex FootPrint WMS ensures that both highly complex and simple processes are handled accurately and meet the required guidelines. Whether the process involves attaching certification documentation to inventory records, quality assurance inspections or other actions, Datex FootPrint WMS can be used to regulate work activities to meet the required inventory management specifications for each and every product and customer
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?
Real Time Live Software Demonstrations
Would you like to see a warehouse management system (WMS) operate in real time? Register today for the demonstration of your choice to see how Datex FootPrint WMS works for the pharma and life science industry.
Here are just a few features pharma and life science industry professionals want to see:
- Secondary packaging and kitting
- Bill of materials
- Multi-dimensional inventory capabilities
- Multi-bin tracking
- Track items across multiple locations
- Quick accurate order fulfillment
Scripted demos available
(Please note that these are no obligation software demonstrations for sales purposes.)
