Lot Traceability System

Pharmaceutical manufacturers, food producers, and medical device companies face a regulatory mandate of existential importance: prove the complete genealogy of every finished product from raw material receipt through customer delivery, and enable tracing backward from any finished product to identify all component lots that contributed to it. FDA Food Safety Modernization Act (FSMA) Section 204 requires food companies to identify the source of any ingredient and trace its path through the supply chain within 24 hours of notification. FDA 21 CFR Part 211 (cGMP) requires pharmaceutical manufacturers to maintain batch records showing all component materials, equipment, and processes used to manufacture each batch. A single product recall triggered by a contaminated raw material can affect hundreds of thousands of finished units across multiple customer orders. Without rapid traceability, a company must either destroy massive quantities of product conservatively (product waste exceeding $10-50M) or distribute recalled products to customers and face legal liability. The regulatory consequences are equally severe: FDA Warning Letters, product seizures, shutdown of manufacturing lines, and loss of market access.

The problem is systemic across most manufacturing organizations. Production records are fragmented across multiple systems: raw material information lives in the ERP system, but the quantities actually used in production are logged in manual worksheets or separate production tracking systems. When a raw material supplier issues a recall notice, quality teams must manually cross-reference material lot numbers against production work orders, identify which finished batches consumed the recalled material, trace those finished batches to customer shipments, and generate a recall notification—work that routinely takes 3-7 days rather than the 24-hour requirement. For products with multiple component lots (a typical pharmaceutical might use 15-30 different raw materials per batch, each from different suppliers and different lots), tracing becomes exponentially complex. Even with dedicated traceability coordinators, manual tracing is error-prone: a single missed batch or mislabeled material lot can result in recalled products slipping through to customers undetected. For food companies with hundreds of supplier lots flowing through blending and consolidation operations, backward tracing becomes nearly impossible—when a pathogen is detected in a finished product, investigators cannot reliably determine which supplier lots were blended into it without painstakingly reviewing production records.

The financial and operational consequences are catastrophic and quantifiable. A pharmaceutical manufacturer with a contamination issue in a single raw material lot discovered post-manufacture had to recall 47 finished product lots affecting 1.2 million units distributed to 340 hospitals and clinics. Because the company's traceability system was inadequate, it took 18 days to identify and notify all affected customers—far exceeding FDA 24-hour expectations. The company incurred $8.3M in product replacement costs, $2.1M in logistics and reverse-logistics, $1.7M in regulatory and legal response, and suffered severe reputational damage leading to a 15% customer base loss. A food manufacturer's traceability failure led to a Salmonella outbreak affecting 450 consumers across six states. The company could not determine the source of contamination in its supply chain, could not trace finished products back to supplier lots, and could not identify which customers received affected product. This resulted in a mandatory FDA import alert, 16 weeks of manufacturing shutdown, $12M in product destruction, and class action litigation. A medical device company's lack of traceability meant it could not support FDA's demand to retrieve a contaminated component lot from the field within 48 hours, resulting in an FDA Warning Letter and mandatory product recall. These aren't rare incidents—they represent systemic operational failures across manufacturing organizations that lack comprehensive material genealogy systems.

The root causes are architectural and process-based. First, fragmentation: raw material information, production consumption, and finished product information are stored in separate systems with no real-time linkage. When production consumes materials, the actual consumption is recorded in handwritten logs, mobile apps, or separate tracking systems that do not feed back to the central ERP system. There is no definitive answer to the question "What raw material lots were consumed in the production of finished batch X?" Second, consolidation and blending: when multiple raw material lots are consolidated into intermediate bulk containers or blended together (a common operation in food and pharmaceutical manufacturing), the genealogy becomes complex. Traceability systems must track not just component lots, but the portion of each lot that went into which intermediate container, then track which intermediate containers flowed into which finished batches. Third, commingling: when multiple production batches use the same equipment with residual carryover of previous batches, or when inventory items are commingled in storage, traceability must account for cross-contamination risk. Fourth, no real-time correlation: most systems cannot correlate a recall notice (referencing a supplier lot number and date range) against production records in real-time to identify affected finished batches. Fifth, regulatory documentation gaps: even when companies have production records, they cannot generate FDA-compliant traceability reports demonstrating the complete chain of custody from raw material through finished product.

The regulatory risk is severe and escalating. FDA FSMA Section 204 audits explicitly test companies' ability to respond to simulated recalls within 4 hours and identify affected products. FDA 21 CFR Part 211 Warning Letters increasingly cite inadequate lot tracing and batch genealogy documentation as critical findings. EU regulations (including the recent EU Delegated Regulation 2023/2038 on animal feed traceability) impose similar requirements. Customers in highly regulated industries (pharmaceutical companies with products sold globally, medical device manufacturers selling to hospitals) increasingly contractually require suppliers to demonstrate rapid traceability capability. A single regulatory finding that a company cannot trace its products drives customers away to competitors with certified traceability systems. For publicly traded companies, inadequate traceability leading to an unsuccessful product recall creates SEC disclosure obligations and shareholder liability exposure.

All solutions run on the IoTReady Operations Traceability Platform (OTP), designed to handle millions of data points per day with sub-second querying. The platform combines an integrated OLTP + OLAP database architecture for real-time transaction processing and powerful analytics.

Deployment options include on-premise installation, deployment on your cloud (AWS, Azure, GCP), or fully managed IoTReady-hosted solutions. All deployment models include identical enterprise features.

OTP includes built-in backup and restore, AI-powered assistance for data analysis and anomaly detection, integrated business intelligence dashboards, and spreadsheet-style data exploration. Role-based access control ensures appropriate information visibility across your organization.