A batch record is the compiled set of production records proving that a specific batch or lot of a medical device was built according to approved specifications and procedures. In device manufacturing, it captures materials, process steps, inspections, and release decisions, giving auditors and recall teams a traceable history for every unit that leaves the line.
What is a batch record?
A batch record (also called a batch manufacturing record, or BMR) is the working document a production team completes while building a defined quantity of devices. It starts as a blank template derived from the approved manufacturing instructions, then fills with real data as the batch moves through the line: who did what, on which equipment, with which component lots, and whether each check passed.
In the medical device world, this record is closely tied to the Device History Record (DHR). Under the legacy FDA Quality System Regulation, 21 CFR 820.184 required a DHR showing that each unit, lot, or batch was made in accordance with the Device Master Record. Since February 2, 2026, the FDA Quality Management System Regulation (QMSR) has replaced that framework and incorporates ISO 13485:2016 by reference. The batch-level record survives the change; the terminology shifts toward the ISO concepts of production records and the Medical Device File.
Why a batch record matters in medical device manufacturing
Getting this record right is a patient-safety issue before a paperwork one. If a component lot proves defective, the batch record lets a team pinpoint which finished devices contain it, so a recall can target specific lots instead of pulling months of production.
The regulatory stakes are concrete too. ISO 13485:2016 requires records of production and service provision (clause 7.5.1) and procedures for identification and traceability (clause 7.5.9), with tighter rules for implantable devices in 7.5.9.2. EU MDR 2017/745 adds full lifecycle traceability, a Unique Device Identification (UDI) for each device, and registration in EUDAMED. A gap in the batch record, such as a missing lot number or unsigned inspection step, is a common finding in FDA inspections and Notified Body audits and can stall a shipment or a submission.
Key components of a batch record
A batch record for a regulated device usually captures the following:
- Batch or lot identity: the lot number, quantity produced, quantity released, and any UDI or control numbers that link the batch back to the finished device.
- Materials and components: the specific incoming lots of raw materials, subassemblies, and purchased parts used, so each finished device traces to its source stock.
- Process parameters: equipment and line used, settings, environmental conditions (for example, cleanroom class), and validated process values recorded as the batch runs.
- In-process checks: results from inspections such as SPI, AOI, and X-ray on medical PCBA, plus functional and visual checks with pass or fail evidence.
- People and timing: operator and reviewer sign-offs, dates, and shift information.
- Deviations: any nonconformance, deviation, or CAPA reference raised during the run and how it was dispositioned.
- Release decision: the quality review and authorization to release the batch for distribution.
Reviewers read a batch record as a narrative of what happened on the line, and that story has to reconcile with the master instructions.
Common challenges and best practices
Paper batch records are where most trouble starts. Handwritten sheets invite illegible entries, missing signatures, and transcription errors, and make lot linkage slow to reconstruct in an investigation. Spreadsheets and shared drives scatter records across systems that no one can tie together under audit pressure.
Strong programs move toward an electronic batch record inside a validated Manufacturing Execution System (MES) or ERP. When software maintains traceability data, ISO 13485 clause 4.1.6 requires that the software be validated for its intended use, so the data holds up during recalls and inspections. Review by exception, where the system flags only entries that fall outside limits, cuts review time without weakening scrutiny. Teams that treat the batch record as live evidence, reviewed in near real time, catch deviations while they can still be corrected rather than discovering them at final release.
How SJML helps with batch records
Syrma Johari MedTech (SJML) builds batch-record discipline into its manufacturing operations as an end-to-end medical device CDMO. Production runs in ISO Class 7 and 8 cleanrooms and ESD-controlled environments, with medical PCBA inspected through SPI, AOI, and X-ray, and process validation carried out via IQ, OQ, and PQ. An SAP-integrated MES supports traceability from incoming components to finished device, and supplier qualification, dual sourcing, and packaging and labeling validation round out the record trail. QARA teams align production records to ISO 13485 and MDSAP expectations.
Talk to SJML’s manufacturing team →
Frequently asked questions
They overlap but are not identical. A batch record captures the production history of one batch or lot as it is made. The DHR is the FDA term for the collection of records demonstrating a unit, lot, or batch was built per the Device Master Record. In practice, batch records are the core evidence that populates the DHR.
Yes. The QMSR took effect on February 2, 2026, and incorporates ISO 13485:2016 by reference, so the explicit DHR wording in 21 CFR 820.184 gave way to ISO production-record and Medical Device File concepts. Manufacturers must still maintain equivalent batch and lot records showing each device was made to specification.
Yes, and most modern programs prefer it. Electronic batch records inside an MES or ERP improve legibility, speed investigations, and support review by exception. ISO 13485 clause 4.1.6 requires that any software used for the quality system be validated for its intended use, so the electronic system must be qualified before it becomes the record of truth.
Retention follows the device lifecycle and applicable regulations, and many manufacturers hold records for at least ten years to satisfy EU MDR and ISO 13485 expectations. The exact period depends on device type, market, and internal procedures, so retention rules should be defined in your quality system and mapped to each jurisdiction you sell into.
A missing signature, lot number, or inspection result is a documentation gap that auditors treat as a control gap. It can trigger a nonconformance, delay batch release, or become an inspection observation. If traceability is broken, a targeted recall becomes harder, which raises both patient risk and cost.
Related terms
- Device History Record (DHR)
- Device Master Record (DMR)
- Lot Traceability
- Process Validation (IQ/OQ/PQ)
- Manufacturing Execution System (MES)
