Medical device companies that wish to sell their products in the United States must demonstrate compliance with the FDA's quality system regulations, found in 21 CFR Part 820. In addition to medical device manufacturers, the FDA also requires companies that make pharmaceuticals and dietary supplements to maintain batch records that show each batch of product was manufactured in compliance with the appropriate requirements.
Each new batch of
According to the FDA, a batch, or lot, means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that
Batches of product typically go through the manufacturing process at the same time. If an error or problem developed in the manufacturing process, products in the same batch should either all be affected by the error or none of them affected by the error. When a product non-conformance is detected, quality managers should look at other products in the same batch to determine whether they too are affected.
The definition of a batch has nothing to do with how many units there are. A batch could include just one unit or hundreds. Medical device companies can determine how best to group product into batches for record-keeping.
Medical device companies should be aware that the FDA regulations in 21 CFR Part 820 make no explicit references to "batch records", but that they absolutely are required. The FDA requires medical device companies to maintain a device history record (DHR) for each medical device they produce, which is essentially the same thing as a batch record.
Manufacturers must maintain device history records for every batch, lot or unit of product that they produce, and the records should demonstrate that the device is manufactured in accordance with the device master record (DMR) and the overall requirements of the FDA QSR. This requirement is further elaborated in 21 CFR Part 820.86 which sets the requirements for acceptance activities. Quality managers must establish acceptance criteria for a manufactured product and ensure that only that product which has passed the criteria can be passed on to the customer.
The device history record should supply the following information for each batch, lot or unit:
Batch records stored and generated electronically are subject to the document control requirements of 21 CFR Part 820.40 and the electronic records regulations set forth in 21 CFR Part 11.
Modern medical device companies generate a huge amount of documentation through electronic batch records, acceptance activities, the establishment of a device master record and the maintenance of device history records for every new batch of manufactured product.
Greenlight Guru's eQMS platform is the ideal solution for medical device companies that wish to reduce their time to market by adopting an electronic quality management system that is out-of-the-box compliant with FDA 21 CFR Part 11 and Part 820. With Greenlight Guru, medical device companies can easily:
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