PHARMA & LIFESCIENCES

Industry specific

Produmex has been designed to meet the unique requirements of the Life Science industries such as Pharmaceuticals, Biotech, Medical devices, Vitamins, Nutraceuticals, Cosmetics and many others.


Serialised Item Management


Third Party Logistics


Contract Manufacturing & Packaging

KEY FEATURES AND FUNCTIONS

Traceability on-demand

Produmex provides complete real-time insight into which vendor supplied a specific lot or serial number and which customers received a specific finished good. In addition, it provides real-time information on changes in quality status, a time stamp of when activities occur and an audit trail of users.

  • Supports forward traceability from ingredients through manufacturing processes to finished goods, which are ultimately shipped to customers.
  • Supports backward lot traceability from finished goods back into manufacturing processes to ingredient and component receipts from suppliers.
  • Traceability of mixed liquids using consumption algorithms
  • Traceability provides the backbone for the management of recalls
  • Supports for QC processes of inbound receipts and manufactured products
  • Complete insight into which vendor supplied a specific lot and which customers received a specific finished good lot
  • Complete visibility to recorded lot properties of ingredients, components, and finished goods

Quality Management

Produmex allows inventory to be managed according to its quality status, ensuring that the right material is used at the right time. This functionality can be used for raw materials, production, packaging, finished goods, returns, and for all processes where inventory is managed or consumed.

  • Management of inventory by quality statuses (Example: quality status can determine whether it can be picked for production, picked for replenishment, whether it can be sold, etc.)
  • Transition stages can be defined for each quality status (i.e. from Quarantined to Released or Rejected)
  • Reason codes associated with quality statuses
  • Integrated with SAP Business One alerts for workflow and escalations
  • User definable quality statuses
  • On-demand traceability of all quality status changes
  • Retest periods can be established for shelf life-managed items so quality control (QC) personnel can reevaluate the physical properties of the given inventory.

Weighing and Dispensing

Real-time controls with Produmex Weigh significantly increase efficiency and quality, compared to manual dispensing operations. This configurable out-of-the-box solution is 21 CFR part 11 compliant, and supports centralized or local weighing and dispensing operations in a regulated environment.

Recall Management

Produmex on-demand traceability allows you to respond quickly to recalls, or to practice mock recalls.

Regulatory compliancy integration

Governments worldwide are increasing the compliance and regulatory requirements for the Life Sciences industry, affecting the entire supply chain from beginning to end. The FDA and other regulatory agencies set the minimum standards for business systems in the areas of security, manufacturing, and quality controls, traceability and overall good manufacturing practices (GMP). Produmex lays the foundation for you to meet and exceed compliance and regulatory requirements.

  • FDA Regulatory Compliance
  • State and Provincial regulatory compliance
  • ePedigree

Warehouse Management

Advanced location management – bulk locations, pick locations, cross docking Inbound logistics – goods receipts, put away Outbound logistics – multiple picking algorithms, shipping Advanced logistics – cycle counting, return logistics (RMA), intercompany warehouse transfers Automatic replenishment Route planning GS1 support

Shelf-life Management

Produmex can address shelf life requirements for products on a generic as well as on an individual customer/supplier level. The shelf life of a product determines whether a product can be delivered to a customer (shelf life for delivery) or received from a supplier (shelf life for reception).

If the sum of the current date and the shelf life of a product (expressed in days) is earlier than the expiry date of a product, it can be delivered to a customer or received from a supplier. If the sum of the current date and the shelf life falls later than the expiry date, the product cannot be delivered or received.

The shelf life of a product can be specified generically or by customer. In the latter case, it can occur that a certain product may still be delivered to one customer, but not to another, based on more stringent shelf life conditions.

Manufacturing & Shop Floor Integration

Produmex extends SAP Business One to meet the needs of more complex manufacturing, including shop floor integration and traceability from raw materials to finished goods to customers. The result is a more responsive, productive and efficient manufacturing operation.

  • Picking for production
  • Touchscreens to manage production and packaging lines
  • Handheld clients available for picking and production
  • Traceability of batches and serials throughout the production process
  • Management of liquids and silos
  • Bottling of liquids (with traceability)
  • Batch traceability of mixed liquids from raw materials through production to finished goods
  • Dispensing for measuring and weighing recipes & formulations
  • Graphical representation of production lines (and warehouse and packaging lines)
  • Actual consumption of labor
  • Shop floor integration to counters, scales and other devices
  • “Optional items” in recipes, formulations and production orders
  • Quantity tolerances allowed in recipes, formulations and production orders

GS1 Support

Produmex supports the global GS1 standards for identification of products and logistic units. These include:

  • GS1 128 barcodes (SSCC – Serial Shipment Container Code)
  • GS1 EAN 13 (GTIN – Global Trade Item Number)
  • GS1 ITF (Interleaved Two of Five)
  • GS1 DataMatrix
  • GS1 eCOM
  • GS1 EPCGlobal

FEFO-Picking

Automatically allocate inventory to sales orders and production processes on a first-expired-first-out basis (FEFO). This process helps to ensure compliance with regulatory requirements, protects the organization from unnecessary recalls, and helps to reduce inventory costs due to product and ingredient obsolescence.