If a QA lead asks which customers received lot 24-117, the team should be able to find the answer quickly. At some biotech companies, that information is scattered across spreadsheets, manufacturer documents, and shipping reports from third-party logistics providers.
NetSuite can help bring these records together. Each lot can be linked to the transactions it passes through, from receiving materials to making products and shipping orders to customers. The key is setting up lot tracking correctly from the start.
Here’s how it works and what biotech companies should consider during implementation.
How Lot Tracking Works in NetSuite
It starts with the item record. Materials that need to be tracked, such as drug ingredients, finished products, kits, and important packaging, can be set up as lot-numbered items. This allows teams to record which lot is involved in each relevant inventory transaction.
The lot can then be tracked through several stages:
- Receiving: When materials arrive, the team records the lot number and expiration date, where applicable. For materials from a contract manufacturer (CMO), the supplier’s lot number should match the information on its certificate of analysis.
- Production: When materials are used to make a product, the team records the lots used and the lot number assigned to the finished product. This helps show which materials went into each batch.
- Inventory movements: When stock moves between locations or inventory records are adjusted, the relevant lot details should be recorded.
- Shipping: When an order ships, the lot number recorded on the fulfillment helps the team identify which customer received the product and when it was shipped.
Many biotech companies rely on outside manufacturers and warehouses instead of running their own facilities. In these cases, their systems need to exchange the right information with the CMO or third-party logistics provider (3PL).
If an integration sends only total inventory quantities without lot numbers, the team may know how much stock is available but not which specific lots were shipped. Confirm that the systems exchange the lot numbers, expiration dates, quantities, and shipment details the business needs.
How to Trace a Lot Forward and Backward
Once lot details are recorded throughout the process, teams can follow a lot in either direction.
Backward tracing answers the question, “What materials went into this product?” Starting with a finished lot, the team checks production records to identify the raw materials used, their suppliers, and when they were received. This can help during a quality investigation.
Forward tracing answers, “Where did this lot go?” Starting with a raw material lot, the team follows it through production to the finished products that used it, then checks the shipping records to identify the customers who received those products. This helps the company understand which products and customers may be affected by a quality issue.
NetSuite records lot details on relevant transactions. Saved searches can help teams find this information without checking multiple spreadsheets manually. The reports need to be set up around the company’s manufacturing process and tested before a quality issue occurs.
Expiration Dates, FEFO, and Inventory Holds
Lot tracking also helps teams manage which products can be used or shipped.
- Expiration dates: Recording expiration dates helps teams identify stock that is close to expiring and plan its use before it becomes waste.
- First expired, first out (FEFO): This approach prioritizes eligible stock with the earliest expiration date. Warehouse and picking processes must be set up to support it.
- Inventory holds: Products waiting for quality approval, or lots that have been rejected, should be marked and restricted so they cannot be shipped when they are not approved for use.
For companies selling products in the US, the Drug Supply Chain Security Act (DSCSA) adds further requirements. Lot tracking is only one part of the process. Companies may also need package-level product identifiers, serialization, and electronic records exchanged with trading partners. These requirements need to be addressed alongside the company’s inventory and shipping processes.
Where Archer Insights Fits
Archer Insights has worked exclusively with health and life sciences companies since 2017. That experience shapes how we plan lot tracking during a NetSuite implementation.
We work with clients to decide which items need lot tracking, how supplier lot numbers should be recorded, what information needs to come from manufacturers and warehouses, and which reports QA and supply chain teams will need.
Archer Insights’ 3PL Integration helps exchange inventory and transaction information with logistics providers, including relevant lot and expiration details. The exact information exchanged depends on the provider and integration setup.
Pharma Serialization Engine supports pharmaceutical serialization workflows. The QMS supports quality processes, including corrective and preventive actions (CAPA). MRP helps companies plan purchasing and production around demand and available inventory.
The goal is to connect inventory, production, quality, and shipping records so teams can find the information they need without piecing together data from different sources.
FAQs
Can NetSuite track a lot from receiving to customer shipment?
Yes. NetSuite can record lot details across receiving, production, inventory movements, and shipping. Complete tracking depends on recording the right information at each step and connecting external systems where needed.
Can NetSuite show which materials went into a finished product?
Yes, when the relevant manufacturing records capture the lot numbers of the materials used. These records help teams trace a finished product back to its ingredients and components.
Does lot tracking alone meet DSCSA requirements?
No. DSCSA requirements can include package-level product identifiers, serialization, and electronic product-tracing records. Companies need to assess these requirements separately from basic lot tracking.
How can biotech companies track inventory held by a CMO or 3PL?
They can connect their systems so lot numbers, expiration dates, inventory quantities, and shipping details are shared. The setup should be tested to confirm that the records match across systems.