Electronic Batch Records: What They Are & How to Get Started

Batch Records are testimony to the fact that your life sciences company is recording all crucial details of every batch of product you manufacture.

The recorded information will assure your company’s internal and external stakeholders, including regulatory agencies, that each and every product is being manufactured according to industry standards and Good Manufacturing Practices (GMPs).

In this article, we will be taking a deep look at what are Electronic Batch Records, their importance and requirements, as well as key areas to consider when transitioning to Electronic Batch Record management.

But first, let us look at the basics:

What Is a Batch Record and Why Is It Important?

In the context of your life sciences (be it a Medical Device, Pharmaceutical, Biotechnology, Cell & Gene industry), a Batch Record is defined as the documentation that will provide the entire manufacturing history of every batch of product that you manufacture.

Every Batch Record is of the utmost importance since it records the equipment, materials, staff, data, labels, events, supplies, laboratory information management systems, process control systems, and enterprise resource planning. This means that every Batch Record will contain the complete in-process and release tests. This information is the assurance to your company’s stakeholders, both internal and external, including the regulatory agencies that your products are manufactured as per the most stringent industry standards.

We can understand this better with the following example.

Your Quality Assurance Department has detected a nonconformance in one of your products during an inspection. The department will now check the other products from the same batch, using the details provided in the Batch Record, to see whether the nonconformance applies to more products.

A Batch Record can also be labeled as a Batch Manufacturing Record (BMR) or a Batch Production Record (BPR). Batch records can include a single unit as is the case for a single patient’s data, for instance, if your company is manufacturing precision gene therapy products. It can also be for 100s of units of a given product.

It should be noted here that the US Food and Drug Administration (US FDA) expects not only medical device manufacturers and pharmaceutical companies to maintain Batch Records, but also companies manufacturing dietary supplements, gene therapy products, and others to do the same.

What Is the Difference Between a Master Batch Record and a Batch Record?

The main difference between a Master Batch Record and a Batch Record is that a Batch Record is a batch-specific copy of the Master Batch Record. This means that each Batch Record shows evidence that a particular batch was manufactured in accordance with the instructions in the Master Batch Record.

What Is an Electronic Batch Record?

When batch records are generated and stored electronically, they are referred to as Electronic Batch Records or EBRs, for short. Irrespective of your life sciences company, you will be generating huge amounts of documents via Electronic Batch Records and maintenance of product records for every batch of products that your company manufactures.

For your company to facilitate compliance using Electronic Batch Records, you will require dedicated software tools. For example, these include specialized tools such as Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), and others. An Electronic Quality Management System (eQMS) like SimplerQMS can also be used for a more simple EBR management. An eQMS system allows you to work more efficiently and helps ensure compliance with the necessary regulatory requirements when you are dealing with documents and records, including EBRs.

Electronic Batch Records Software built into SimplerQMS allows your personnel seamlessly and easily create, store, and retrieve Electronic Batch Records. You are assured that these records are secure, and unlike traditional methods of document management, you will never lose or misplace any document.

What Are the Benefits of Electronic Batch Records?

When a life sciences company implements Electronic Batch Records, it accrues various benefits. These benefits can be broadly categorized as follows.

Reduction of Human Error

Human error, including misplacing or losing documents, routing documents to the wrong locations, and others, result in wastage of precious time, money, re-audits, and possibly loss of brand value.

For example, there is an audit in process, and your personnel is running helter-skelter trying to locate the Batch Records of a particular product.

With the implementation of an efficient Electronic Batch Record management solution or an eQMS like SimplerQMS, you will not face such problems. At the click of a mouse, you will be able to produce the relevant document for the inspectors.

Compliance With Regulatory Requirements

To be compliant with current regulatory requirements, your life sciences company needs to capture accurate information in the form of data and records, organize this information, and present it in a suitable manner.

With traditional paper-based documentation systems, these processes become cumbersome.

Imagine the scenario where the Quality Department in your medical devices company has been asked to present the batch records for a specific batch of implantable pacemakers to the auditors from the US FDA. Considering that your company produces numerous batches of this device every year, it will become very difficult to manually search and identify the given batch.

On the other hand, by using Electronic Batch Record systems, the Quality Personnel can get the required information within seconds.

Reduction in Warehouse Inventories (Optimizing Manufacturing Processes)

If a life sciences company is using manual processes for capturing complex data for batch records, it is most likely to face data integrity issues, errors with warehouse inventories that will result in the repetition of inventories, and other problems.

Let’s imagine that there has been an error with warehouse inventories of the HMG-CoA reductase inhibitor (Atorvastatin) that a pharmaceutical company is a leading manufacturer of. These types of errors have increased over the last few years because the company is persisting with manual paper-based documentation. Now, let us consider that the same company transitioned into Electronic Batch Records two years back – the entire process would have been much more streamlined.

Electronic Batch Records will not only improve data integrity and accuracy but also help to streamline processes and optimize manufacturing process efficiency by reducing production cycle times and guaranteeing workflow consistency.

Improved Visibility/Traceability

Data storage is both difficult to access and disengaged when manual paper-based documentation systems are used. These inefficiencies result in traceability issues, especially when the company is facing an important audit.

After implementing EBRs, you are provided with a centralized storage location, document linking, electronic signatures, and much easier compliance with current regulatory guidelines.

What Are the Requirements for Electronic Batch Records?

The main regulatory requirements for batch records in the context of the life sciences industry including medical device and pharmaceutical industries are mentioned below.

Requirements for Medical Devices Companies

When medical device companies sell their products in the US market, they come under the purview of the US FDA. The overarching guidelines of the FDA are that every medical device must be safe and effective to use in its given clinical setting.

Medical device companies need to maintain a device history record for every medical device they manufacture and sell. This essentially is equivalent to a batch record.

Each manufacturer shall maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

a) The dates of manufacture;

b) The quantity manufactured;

c) The quantity released for distribution;

d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

e) The primary identification label and labeling used for each production unit; and

f) Any unique device identifier (UDI) or Universal Product Code (UPC), and any other device identification(s) and control number(s) used.

These records will be in accordance with your company’s device master record.

21 CFR Part 820.181 states that every medical device manufacturer must maintain device master records that are prepared and approved as per regulatory requirements.

Overall, your medical devices company should be compliant with the FDA Quality System Regulations (QSR) as defined in 21 CFR Part 820.

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

This also means that you will need to follow the document control requirements laid out by 21 CFR Part 820.40.

Additionally, 21 CFR Part 11, and other requirements become mandatory if your company is handling documents electronically. More on this shortly.

Medical device companies selling their products in the European Union are governed by the European Medicines Agency (EMA) guidelines on Good Manufacturing Practices (GMPs).

Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer’s Quality Management System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media.

Volume 4, Chapter 4 (Documentation) emphasizes that good documentation is crucial for the company’s QMS and for compliance with GMP requirements.

The company’s QMS must define the different types of documents and media that are used. Also, such documentation may be in different formats, including electronic media.

The EMA GMP Chapter 5 gives details on batch records. It mentions that the company should maintain batch numbers, the status of contents, designated product name/internal code reference, expiry date, and so on for all products.

Regulatory Requirements for Pharmaceutical Companies

When your company is dealing with pharmaceutical products, you will come under the purview of 21 CFR Part 211.188 when you are selling in the North American market and EU GMP guidelines when marketing in the European Union.

To learn more about cGMP, you can read our article about what are Current Good Manufacturing Practices (cGMP).

Requirements for Electronic Batch Records

In addition to the general requirements for batch records, there are also specific requirements for storing and managing them electronically.

US FDA 21 CFR Part 11

The US FDA 21 CFR Part 11 regulations apply to all records that the company maintains in electronic form. These include records that are created, modified, archived, maintained, retrieved, or transmitted in electronic formats. The regulation stipulates that electronic records and signatures are just as trustworthy and reliable as paper records. And they are to be treated as equivalent to paper records.

EU Annex 11

The European Union’s Annex 11 (Computerized systems) will apply to all types of computerized systems that are used as part of your company’s GMP-regulated activities. Annex 11 stipulates that you need to have a validation plan in place for all computerized systems.

GAMP 5

Good Automated Manufacturing Practice 5 (GAMP 5) gives details for a recognized standard for computer system validation that will ensure quality for life sciences companies, including pharmaceutical and medical devices.

SimplerQMS’s platform is an ideal solution for life science companies to streamline their compliance with Electronic Batch Records and the overall Quality Management System. Out of the box, SimplerQMS addresses the requirements of 21 CFR Part 11, EU Annex 11, GAMP 5, FDA 21 CFR Part 820, and requirements.

What Does an Electronic Batch Record contain?

A typical Electronic Batch Record will contain the following elements.