Häufig gestellte Fragen
How quickly must batch traceability data be available?
EU Regulation (EC) No 178/2002 requires food and feed businesses to make traceability data available to the competent authorities on request; in Germany, Section 44(3) LFGB specifies that the information must be transmittable electronically no later than 24 hours after the request, with the mandatory structured, common, and machine-readable format applying since 1 January 2023 following a transition phase. Independently of this regulatory deadline, the operational goal is to be able to retrieve a where-used record in the ERP within minutes rather than hours, since in a recall every delay enlarges the affected market. How quickly a specific full query is actually available depends on data quality, the consistency of batch management across all modules, and the customizing depth of the respective system. Blanket hour figures should therefore always be assessed in the context of your own processes and the regulations currently in force.
What is the difference between batch traceability and serial number tracking?
A batch comprises a defined quantity of similar units produced under uniform conditions and identified by a common batch number, whereas a serial number uniquely identifies a single unit. Batch tracking is sufficient in many industries because quality or safety problems usually relate to an entire production batch, so a recall is then carried out batch by batch. In the pharmaceutical industry, both levels come together: under the EU Falsified Medicines Directive 2011/62/EU, prescription medicines must carry, in addition to the batch number, an individual serial number in a 2D Data Matrix code on every single pack. The required granularity therefore follows from industry regulations and the product, not solely from what is technically possible.
In which industries is batch traceability legally required?
For food and feed, traceability has been mandatory since 1 January 2005 under Article 18 of EU Regulation (EC) No 178/2002; the "one step forward, one step back" principle applies there, meaning every business must be able to document its immediate supplier and its direct commercial customer. In pharmaceuticals and medical technology, more far-reaching requirements apply from the GMP and GDP frameworks, GxP validation, and the serialization obligation under the Falsified Medicines Directive, which has been applicable since 9 February 2019. Cosmetics, chemicals, and parts of the automotive and electronics supply industries are also subject to comparable documentation obligations. The exact scope and validation depth differ considerably by industry, product, and target market and should be assessed against the specifically applicable regulations.
What do forward and backward traceability (tracking and tracing) mean?
Tracking, or forward traceability, starts from a raw material or incoming batch and determines which production batches and finished products it went into and which customers received them. Tracing, or backward traceability, works in reverse, reconstructing from a finished product which raw materials, semi-finished goods, and production steps were involved. Both are made possible by consistently linking batch numbers across bills of materials, production orders, and stock movements, creating an analyzable network of relationships. Only both directions together provide the complete track-and-trace capability that a precise recall requires.
How long must batch data be retained?
In the food sector there is no fixed EU-wide uniform period; retaining traceability data for around five years is common, with the duration in practice guided by the product's shelf life and national requirements. For medicinal products, Chapter 4 of the EU GMP Guide requires batch documentation to be retained for at least one year after the batch's expiry date or at least five years after certification by the Qualified Person — whichever period is longer applies. These figures are legal minimum requirements that companies may extend contractually or for liability reasons. For your own case, the specifically applicable industry and national regulations should be consulted, as the periods stated here vary by product and market.
What requirements must an ERP system meet for batch traceability?
What matters most is end-to-end batch management across all modules — from purchasing and goods receipt through warehousing and production to shipping — without media discontinuities, so that every movement is recorded with a batch reference. The system should handle mixed and split batches as well as multi-level bills of materials, evaluate where-used records quickly, and provide a complete, tamper-proof audit trail, which in regulated environments often has to be validatable under 21 CFR Part 11. Mainstream solutions such as SAP S/4HANA, Microsoft Dynamics 365, or industry-specific systems all support batch management but differ significantly in functional scope and in validatability for regulated industries. An evaluation should therefore always be based on your own regulatory requirements and processes, not on generic product claims.