ELECTRONIC BATCH RECORDS

MEDICAL DEVICE COMPANIES THAT ARE ADOPTING PAPERLESS QUALITY SYSTEMS AND MANUFACTURING PROCESSES USE ELECTRONIC BATCH RECORDS TO MEET THE DEVICE HISTORY RECORD REQUIREMENTS OF 21 CFR PART 820.184.

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 product generates a batch record that the medical device company must store and retain. Electronic batch records offer a paperless solution for maintaining and accessing batch records that complies with the electronic records requirements of 21 CFR Part 11.

WHAT IS A BATCH?

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 are manufactured under essentially the same conditions and are intended to have uniform characteristics and quality within specified limits.

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.

WHAT ARE ELECTRONIC BATCH RECORDS?

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:

• The date or dates of manufacture
• The quantity of product in the batch or lot
• The quantity released for distribution
• The acceptance records which demonstrate manufacturing in accordance with the DMR
• The primary identification label and labeling used for each production unit
• Any unique device identifier (UDI), universal product code (UPC) or control numbers used to identify the product

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.

Greenlight Guru Facilitates Compliance with Electronic Batch Records and DHR

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:

• Create, store and securely access electronic batch records
• Seamlessly link electronic batch records to supporting documents such as documented acceptance activities, device master record and inspection reports
• Automatically generate reports that show compliance with design controls, CAPA, risk management and other FDA-regulated quality processes
• Build true quality into their device, manufacturing operations and their organization as a whole