Improving Coordination between Contract Manufacturing Organizations and their Customers

Customer Overview

Our customer, an international pharmaceutical contract manufacturing organization (CMO), provides manufacturing, import logistics and material storage solutions for large pharmaceutical organizations. The services provided vary substantially from customer to customer. Customer SOP compliance is paramount for both the customer and the contract manufacturer.

Solution Needed

The CMO required a solution that documents and maintains an electronic audit trail of all interactions with its customers and eliminates the need for email or phone communication. Email and/or phone communication presents the customer with a tremendous amount of compliance risk that may affect patient safety or product quality. Furthermore, the CMO’s customers must have visibility into their current inventory balances, material lots, receipts, shipments and manufacturing orders.

Key Challenges

• A portal is needed to allow the customer to view their material and initiate activities.

• This “customer facing” portal must be secure and unable to directly access information behind the CMO’s network firewall

• Realtime visibility is needed for all material attributes (quantity, unit, expiry date, status etc.)

• Workflows must be supported for batches and all material movements in and out of the plant.

• Transactions must be initiated by the client and accepted by the CMO before “in plant” activities commence.

• A complete audit trail must be provided showing who did what, when and why.

• Maintaining an FDA-compliant state

Our Approach

1. Install Application Software

Slingshot’s Inventory Management, Request and CMO Portal application were installed. The Inventory and Request modules were installed behind the CMOs firewall. The CMO portal resides on a dedicated Microsoft Azure instance. Communications between the two environments are handled via encrypted web services.

2. Configure Workflows

Material Receipt Request – Informs the CMO of material destined for a CMO plant. This request includes a receiving plant and an expected receipt date along with a list of material lots being shipped to the CMO. For each lot the material item code (GTIN), Quantity, Unit of Measure, Manufacturing Date and Expiration Date are provided.

Material Shipment Request – Instructs the CMO to ship the customers material to another location. This request includes a shipping plant, ship to address and expected ship date along with a list of lots being shipped. The lot number, quantity and unit are provided for each lot.

Destruction Request – Instructs the CMO to destroy certain material lots. This request includes a shipping plant, along with a list of lots being destroyed. The lot number, quantity and unit are provided for each lot.

Lot Change Request – Instructs the CMO to change the status or expiration date for certain lots in the warehouse. This may require material relabeling and or relocating. The lines on the request are a list of lot numbers along with each lot’s new Status and/or Expiration Date and/or Retest Date.

Batch Request – Instructs the CMO to process a manufacturing batch. The batch has a manufactured Material Item (GTIN), Producing Plant, Need Date and list of component lines. Each component line is a Material Item, Quantity, Unit and a list of Lot Number / Quantity pairs.

3. Provide Real Time Visibility

Display Workflows – Workflows are listed along with status (Pending, Open, Complete). Pending workflows can be edited until submitted for approval.

Display Inventory Balances – Current balances for each material item and lot are presented on the portal and synchronized in real time.

4. Configurate Approval Process

Requests requiring approval are initially placed in a “Pending Approval” status. Approval can be granted by one or more authorized CMO personnel. Once approved the request’s status is advanced to “Open” and is available for in plant processing. If approval is denied the request is routed back to the customer for revision and resubmission.

5. Import CMO Data

The CMO’s locations (GLN) material items (GTIN) and lot balances (SGTIN) are imported into the inventory application.

6. Train CMO Personnel and CMO Customer personnel

Minimal time required to onboard new customers. Approvals completed by CMO personnel utilize existing Slingshot ERP functions (no new training).

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Outcomes

New Customers: Portal provides differentiation versus other CMOs. These unique capabilities resulted in new customers.

Increased Revenue: New services such as reports, material testing and physical inventory requests initiated on the portal resulting in incrementation revenues.

Operational Efficiency: Decreased time composing or responding to emails equates to less risk and less effort. Self-service inquiry and request entry saves time for the CMO and customer alike.

Enhanced Auditability: All requests, approvals and fulfillment activities meticulously tracked. No information lost due to emails being cleaned up.

Real Time Visibility: Availability of current, accurate inventory data improves decision making.

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Client Testimonial

"Our customers love the capabilities Slingshot’s portal provides. No more miscommunication. Realtime Visibility. Fewer emails and phone calls to respond to.”

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Why Choose Us

Slingshot has 20 years’ experience delivering ERP solutions. Slingshot applications are rigorously validated, comply with the FDA’s DSCSA and 21CFRPart11 requirements and include complete validation documentation.

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