How to Choose the Right Traceability Software for Regulated Manufacturing

Early 2026 data shows that recalls remain a steady reality for regulated manufacturers. Sedgwick's U.S. Product Safety and Recall Index showed that regulators recorded 1,634 recalls in the first half of 2026, on par with 2025. Life sciences products accounted for a large share of those recalls, making up almost 40% of all recall events across the five industries Sedgwick tracks.

Every one of those events affects a business’ bottom line. Sedgwick warns that a single large recall can quickly transform a company's operational, financial and reputational risk. When a recall happens, manufacturers need to identify affected product correctly the first time. The right traceability software makes that possible.

Traceability software connects the records needed to follow materials and products through the entire lifecycle: design, material sourcing, production, quality control, release, distribution and post-market monitoring. Digital solutions that support this work must go beyond tracking lot and serial numbers. The software must also preserve genealogy across real production events, linking operational records to quality data and providing the framework to quickly retrieve the appropriate evidence when required for an audit, investigation or recall.

We’ll show you how the right traceability software can improve regulatory compliance and mitigate quality and operational risk, outlining platform requirements and how to test whether a system will hold up in a regulated manufacturing operation. 

Contents

Step 1: Define your traceability requirements

Step 2: Map traceability across the product lifecycle

Step 3: Verify genealogy holds up in a real production environment

Step 4: Confirm quality records connect to genealogy

Step 5: Check electronic record controls and regulatory fit

Step 6: Consider validation needs

Step 7: Test the system with realistic scenarios

Step 8: Assess integration and data migration

Step 9: Review reporting and visibility features

Step 10: Evaluate fit and total cost of ownership

How QT9 delivers end-to-end traceability

Step 1: Define your traceability requirements

Start by defining what your organization needs to trace and how precisely. Keep in mind that the level at which you track product determines how precisely you can recall it. For instance, if your system only traces to the batch level, a problem with a few units may force you to recall the entire batch. Tracing by serial number or unit lets you isolate only the affected product.

Consider the following:

• Traceable objects: Materials, components, subassemblies, finished products, equipment, documents or other records that must remain identifiable

• Identification level: Batch, lot, serial number, work order or individual unit, and whether different products need different levels

• Trace direction: Backward to suppliers and materials, forward to customers and shipments, or both

• Scope: Whether you need to isolate affected product by date range, line, equipment, operator or component lot

• Record relationships: Connections between operational transactions and quality records

• Data retention: How long records must remain retrievable

• Retrieval expectations: How quickly teams must produce records during audits, investigations or recalls

• Site coverage: Whether traceability must span multiple plants, warehouses, business units or contract manufacturers

• Regulatory controls: Electronic signatures, audit trails, approvals, access control and validation

Involve the right stakeholders

Each function uses traceability data differently. Leaving one out tends to create gaps that surface later. Assign each group a role in the evaluation of traceability software.

Step 2: Map traceability across the product lifecycle

Traceability begins before production and continues after distribution. Confirm that the software you’re considering supports each lifecycle stage relevant to your products.

Some systems perform well in production but connect poorly to design or post-market quality. Evaluate the full lifecycle, not a single department's workflow.

Step 3: Verify genealogy holds up in a real production environment

Product genealogy is the record of how materials and components become finished products. It lets you trace backward from a product to its sources and forward from materials to every product and customer reached. Most systems handle simple cases well. The real test is whether genealogy stays intact when production doesn't go as planned.

Ask vendors to demonstrate connected records for the following:

• Material lots split across production orders
• Multiple lots combined into one batch
• Substituted materials or components
• Rework that consumes additional materials
• Scrap and partial quantities
• Transfers between locations
• Contract or outsourced processing
• Returned products placed back into inventory
• Products repaired, replaced or re-released

If genealogy breaks at any of these points, the system cannot give you complete answers during a recall.

Step 4: Confirm quality records connect to genealogy

Genealogy shows how a product was made. Quality records show whether it met requirements and how problems were handled. Both are essential, but they're only useful together if the software links them. The system should connect products and materials with:

• Incoming, in-process and final inspections
• Deviations and nonconformances
• Material review and disposition
• Rework
• Corrective and preventive actions (CAPA)
• Supplier corrective actions
• Complaints
• Risk assessments
• Change control and document revisions
• Training and equipment records

For example, in a failed incoming inspection, the system should identify the supplier, purchase order and received material and also preserve the inspection result, material status, nonconformance, disposition and any resulting supplier corrective action. After shipment the same principle applies: a complaint should stay connected to the customer, shipment, lot or serial number, production history and investigation.

Without these links, teams may have every record they need and still spend days working out how the records fit together.

Step 5: Check electronic record controls and regulatory fit

Regulated manufacturers must protect the integrity of electronic records. Depending on your products and markets, traceability software may need:

• Role-based permissions and secure access
• Electronic signatures and approval workflows
• Time-stamped audit trails that preserve previous values
• Revision control and change histories
• Defined record retention

Beyond these shared controls, confirm the system supports your sector's specific requirements:

Medical device: Confirm that lot, serial, expiration and manufacture date fields map to the Unique Device Identification (UDI) and remain linked through shipment, complaint and recall records.

Aerospace: AS9100 addresses identification and traceability as well as configuration management and prevention of counterfeit parts. Look for traceability to the configuration and document revision in effect at the time of build. Also look for first article inspection linked to that revision and supplier documentation that supports counterfeit part controls.

Pharmaceutical: Many markets require drug manufacturers to serialize products at the package level and share that data with supply chain partners. Serialization is often handled by a dedicated provider, separate from the systems that manage internal batch genealogy. Ask each vendor whether it manages serialization data itself or integrates with a provider, and how serial numbers link back to batch records.

For every control, ask vendors which are standard, which require configuration and which remain your responsibility.

Step 6: Consider validation needs

Regulated manufacturers must validate the software used in their quality system and production processes to show that it performs as intended. Regulators and industry guidance increasingly favor a risk-based approach that focuses validation effort on the functions with the greatest impact on product quality and patient safety. What a vendor provides directly affects how much validation work falls on your team.

Validation effort can change a system's true cost, so evaluate it before you sign. Look for a vendor that provides:

• Validation documentation and test evidence you can use in your own validation
• A certified quality management system of its own
• A documented process for testing and communicating software updates
• A clear plan for keeping the system in a validated state as it updates

Step 7: Test the system with realistic scenarios

Give every vendor the same scenarios, ideally using sample data that resembles your own, and watch how the system handles each one from start to finish.

• Supplier lot: Trace a supplier lot forward through receiving, inspection, production, finished goods and shipment. Watch for genealogy that stops at the first work order.

• Customer complaint: Trace a complaint back to the shipment, lot or serial number, production history and related investigations. Watch for complaints linked to a customer but not to specific product.

• Document revision: Show which specification and instruction revisions applied to a completed order and whether operators were trained on them. Watch for systems that only show the current revision.

• Material hold: Place a lot on hold and confirm the system blocks it from production and flags affected orders. Watch for holds that rely on users noticing a status field.

• Mock recall: Identify all affected inventory, orders, shipments and customers for one lot. Check that every unit is accounted for and that scope can be narrowed by date, line or equipment.

Step 8: Assess integration and data migration

Traceability often spans ERP, quality management, design, warehouse, laboratory and reporting systems. Determine how information moves between these processes:

• Which system owns each record?
• Is master data shared or duplicated?
• How often does information update?
• What happens when data integration fails, and who is alerted?
• Are record relationships preserved across systems?
• Can users move directly from an operational transaction to its related quality event?
• Who supports and maintains the integration?

Native data connections reduce dependence on third-party providers, but architecture alone does not confirm software fit. The demonstration should show connected processes working end to end.

Understand the implementation process

Data migration is one of the most overlooked parts of a traceability evaluation. At go-live you may have open lots, work in process and product already in the field, plus historical records still within their retention period. Ask each vendor how it migrates open inventory and genealogy and how historical product history stays retrievable. Ask what happens to records that remain in the legacy system.

Step 9: Review reporting and visibility features

Reporting is where traceability data becomes useful day to day. Instead of waiting for an audit or recall to pull records, leaders can spot problems early, such as a supplier with rising rejection rates, a product line with repeat complaints or overdue actions piling up. That only works if the reporting tools are flexible enough to answer the questions each team asks.

When comparing systems, look for:

• Configurable dashboards
• Filters by product, lot, supplier, customer or location
• Exception and status reporting
• Trend analysis
• Scheduled and cross-site reporting
• Connections to external data sources
• Drill-down access to supporting records

Step 10: Evaluate fit and total cost of ownership

A capable system can still be a poor fit if it is difficult to implement, maintain or use. Include these factors in your traceability software evaluation:

• Industry support: Can the vendor demonstrate workflows using your regulatory terminology and product records?

• System scope: Does the platform cover the lifecycle stages you need, or depend on additional applications?

• Deployment: Do cloud or on-premise options, security and update procedures align with your IT strategy?

• Usability: Can production, warehouse and quality personnel enter and retrieve information without unnecessary navigation? Include them in testing.

• Scalability: Will the system support growth in users, sites, products and transaction volume?

• Support: Who handles implementation, training, upgrades and integrations, and is support delivered directly or through third parties?

• Ownership cost: Account for licensing, implementation, validation, integrations, data migration, infrastructure, training, support and future expansion. A lower initial price may not mean a lower long-term cost.

How QT9 delivers end-to-end traceability

QT9 connects operational and quality records natively through QT9 ERP, QT9 QMS and the QT9 Business Intelligence application.

QT9 ERP manages operations, such as purchasing, inventory, production, jobs, material usage, shipping and returns. Lot and serial information stays connected as materials move from receiving through production and customer delivery, supporting supplier, production and aftermarket traceability.

QT9 QMS manages design controls, engineering changes, controlled documents, supplier quality, inspections, nonconforming product, CAPA, customer feedback and other quality records. QT9 ERP and QMS integrate natively, connecting quality processes with purchasing, inventory, production and customer records. Customer complaints and returns are automatically associated with affected shipments, lots and serial numbers.

QT9 BI is business intelligence software that combines QT9 QMS, QT9 ERP and external data sources in dashboards, KPIs and reports. Quality and operations leaders can review performance across suppliers, products and processes while keeping access to the records behind the results.

Together, these products support traceability from design and supplier activity through manufacturing, release, distribution and post-market quality.

Choosing quality and operations software with confidence

The right traceability software does more than track lots and serial numbers. It connects every material, process and product to the quality and compliance evidence around it, from design and supplier activity through production, distribution and post-market quality. When evaluating systems, look for:

• Complete product genealogy that holds up through splits, substitutions and rework
• Quality records linked directly to materials, production and shipments
• Secure electronic records with audit trails, electronic signatures and access controls
• Vendor support for validation
• Integrated operations and quality data without fragile third-party connections
• Reporting that drills down to the records behind every result

QT9 brings all of this together in one connected platform. QT9 ERP, QT9 QMS and the QT9 Business Intelligence Tool share data natively, so traceability spans quality and operations. Pre-validated software, unlimited training and support, and free updates help keep implementation manageable and ownership costs predictable.

Schedule a QT9 demo to see connected traceability in action.