FSMA: The Sanitary Transport Rule
The FDA requires manufacturers to maintain Device History Records (DHR). Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain. The Device History Record is meant to be a collection of records containing all production-related documentation of a device that has been manufactured and released into inventory. The goal is to be able to provide proof that the device in question was manufactured according to the requirements spelled out in the Device Master Record (DMR).
The DHR is required to include the date of manufacture, quantity manufactured, quantity released into inventory, acceptance records, unit and packaging labels used for each Lot, along with any device identification and/or control numbers used.
This will also allow you to have traceability of the components used to manufacture the device, stored in one central location. Data indicates that the majority of 483’s issued by the FDA are due to deficiencies in traceability or poorly defined guidelines for establishing traceability in records.
In Mesa Labs’ biological indicator facilities, we typically refer to a DHR as either a “Lot File” or “Batch Record”. All of the forms generated during the production of one Lot is contained in this record. This will include laboratory, assembly & packaging, and QA related information: spore dilution preparation, inoculation, population assays, resistance testing, assembly of product, labeling, certificate of analysis, and Quality review/inspection points. These records are maintained for the life of the product, if not longer.
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