Is it enough to add one single certificate of analysis to the product?

If a certificate describes a specific batch, it must be linked to that batch and the actual shipment. The product specification specifies the requirements and the result of the analysis is the data for the specific quantity.

How do you maintain traceability when the material is repackaged?

An actual connection between the original and the new package or batch is required, the quantity and the action performed. If the materials are mixed, the origin of the resulting quantity must be restored according to the approved process. A new warehouse code alone does not create this connection.

How do you assess the faster submission of a batch document?

The time is measured to link the proper, already approved document to the shipment and submit it to the recipient. Waiting for a laboratory test or quality solution is distinguished. Part of the documents that are improperly assigned is also checked.

Does the resulting certificate of analysis automatically allow batch dispatch?

The quality process must confirm that the document and results meet the conditions for a specific material and order. The presence of the document is not the same as the confirmed release state.

Raw material batch and quality document traceability system

The employee finds the results of the raw material batch research, quality solutions and deliveries. It is possible to determine where the stock remained and which customers received the batch.

The reception batch, analysis certificate, laboratory results, warehouse status and dispatch are managed separately. The customer receives the certificate late, and in case of non-compliance it is difficult to quickly trace the affected quantity.

How the solution works

The quantity accepted shall be linked to the supplier's lot and the quality documents submitted to him.
The quality specialist shall confirm whether the lot can be used or sold in accordance with the laboratory results and applicable requirements.
The dispatch records the batch and quantity passed on to the customer and accompanies the documents for it.
The non-conformity found is returned to the quality process with a list of affected deliveries and stock.

Key challenges

Batch and quality documents are not seamlessly linked

Solution capabilities

Batch reception

The batch, supplier, quantity, documents and initial state of quality are registered at the time of admission.

Certificate of analysis and laboratory data

The analytical certificate and laboratory results are associated with a specific batch and version.

Quality and Quarantine Status

The lot cannot be sold until it has reached a proper quality state.

Dispatch Connection

During the set-up, it is recorded which batch and quantity are sent to a specific customer.

Search back and forth

Customers and balances are found from the batch, and from the customer's delivery a specific batch and certificate of analysis.

Business context

Batch and quality documents are not seamlessly linked: The reception batch, analysis certificate, laboratory results, warehouse status and dispatch are managed separately. The customer receives the certificate late, and in case of non-compliance it is difficult to quickly trace the affected quantity.
batch documents help to accept raw materials more quickly: The customer's quality team can hold the material until they receive the research results that belong to it. Together with the presentation, the batch history provided reduces additional alignment. The supplier can explain the quality issue more quickly, and the customer has more clarity in planning the use of the raw material in production.

Core features

Batch reception
Certificate of analysis and laboratory data
Quality and Quarantine Status
Dispatch Connection
Search back and forth

Key integrations

Warehouse management system (WMS): batch, warehouse state and set-up.
Enterprise resource planning system (ERP): Purchases, customers and orders.
Laboratory Information Management System (LIMS) / Quality System: Laboratory Results and Quality Solution.
Document system: analytical certificates and related quality documents.
Business customer portal: Self-service of client batch documents.

Potential impact (%)

The ranges indicate an illustrative relative change in the metric under the stated assumptions. Results depend on the starting position and actual use of the solution. Percentages for different metrics must not be added together.

Active collection time for batch and presentation history

16–42%Decreasing

This illustrative scenario assumes that 40-70% of information searches and repeated cross-checks can be addressed. That share is assumed to fall by 40-60%. Company data is needed to verify both the addressable workload and the resulting change.

A check search from supplier batch to recipients and back is measured, while checking the completeness of the quantity.

Part of shipments with incorrect or non-transmitted batch documents

5–25%Decreasing

This illustrative scenario assumes that 20-50% of missed actions can be identified through task and deadline tracking. That share is assumed to fall by 25-50%. Company data is needed to verify both the addressable share and the resulting change.

The number of shipments that had a document transfer error is divided by all batches in the period for which a batch document is required and multiplied by 100.

Conditional calculation scenarios. The assumptions have not been validated against client measurements.

When this solution is relevant

Customers often ask for a certificate of analysis for a specific batch
Batch and laboratory data are kept separately
Quarantine status is manually controlled
During the incident, a list of customers is collected from several systems
An Important Process of Auditable Quality

Implementation requirements

Actual quantities, shipment documents and quality solutions are compatible for batch traceability. Transfusion, repackaging or mixing activities describe the relationship between initial and received batches, the balance of quantity, and the responsibility for investigating discrepancies.