Design and Implementation of Electronic Batch Recording Systems


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This article discusses an updated perspective concerning the issues to consider when implementing an electronic batch recording system, based on recent US Food and Drug Administration policy announcements regarding enforcement of the 21 CFR Part 11 regulation.

Paper batch records have been used for decades to record procedures, the type and quantity of each material used, and the status of each step in the manufacturing process for both pharmaceuticals and medical devices. Although paper batch records are less complicated to implement than their electronic counterparts, and the controls required for data recording and archival are well understood, a paper batch record system is laborious to maintain and prone to human error, which increases the compliance risk. Additionally, batch records have become bulky and more time consuming to prepare and review, particularly as manufacturing operations become increasingly complicated. Advances in technology and science have created a more competitive climate in life science industries than ever before, causing the need for manufacturers to reduce costs and time-to-market, and improve their ability to satisfy the compliance requirements of US Food and Drug Administration (FDA) regulations. The use of electronic batch recording systems (EBRS) and electronic batch records (EBR) offers one solution.

Batch records life science During the last several years, technological evolution has seen discrete instruments/control systems featuring paper batch records being replaced with computerized systems and custom information technology (IT) software applications, which are used in good manufacturing practice (GMP) areas. Examples include a spreadsheet to calculate in- process control (IPC) values and the use of enterprise resource planning (ERP) systems to manage master batch records or bills of material (BOMs).

At the same time, there has also been a trend towards more complex business practices and the need to manage electronic data across many platforms and functional areas within an enterprise, such as process control, plant management, enterprise management and supply chain management systems. Manufacturing automation systems, for example, have increased in complexity to the point where a typical system now includes hardware, control logic software, human machine interface (HMI) for monitoring, and/or manual control of the process and data acquisition functionality. This situation has evolved such that a single batch record may contain data from hundreds of separate sources. (Figure 1).

Figure 1 Possible batch record data sources.

In many cases, batch records have evolved into “hybrid” records; that is, electronic data produced by computerized systems are being used to create paper records, which are then signed by hand. This fragmented form of GMP information increases the risk of non-compliance, does not significantly reduce the chance of error and increases batch record review times causing a delay in product release. To date, the results indicate that there is no real net gain, relative to traditional paper records, by applying IT in this way. What is needed is a way to consolidate and integrate fragmented GMP data to reduce the compliance risk, improve performance and increase profitability. Current industry dynamics Because computerized systems have become so prevalent, FDA has worked closely with industry to prepare guidelines and regulations governing electronic records and signatures. In 1997, it enacted 21 CFR Part 11 – a regulation that defines the criteria by which the agency will accept electronic records and electronic signatures in lieu of paper records and handwritten signatures when submitted or used to support submitted records, as required by existing predicate rules. All computerized systems that produce GMP relevant electronic data or records must comply with Part 11 requirements.

During February, in an effort to provide clarification for interpreting Part 11, FDA announced the withdrawal of all previous draft guidance, as well as its compliance policy guide regarding Part 11, and issued a single draft guidance for industry. The key elements of the new guidance are

  • a risk-based approach
  • a more narrow focus of which records will be considered subject to Part 11
  • enforcement discretion regarding legacy systems.

Batch record data are integral to tracking and maintaining the quality, safety and efficacy of the product(s) and should be considered high risk. Therefore, all data contained in an EBR that are required by the predicate rules would be subject to the requirements of Part 11. It is unlikely that the good electronic data management methods defined in Part 11 will be modified by FDA.

Currently, the industry is faced with the challenge of integrating functionality between applications with seamless connectivity across many different platforms and consolidating fragmented GMP data, while complying with the regulatory requirements of Part 11. Implementing an EBRS is one way of meeting these challenges and there are many benefits by doing so.

EBRS considerations EBRS is not simply a documentation system; it also addresses issues related to the work flow of the operations being performed. Although this article focusses on manufacturing operations, the benefits derived from an automated electronic records system can be realized elsewhere in the product life cycle including research and development, and clinical trials.

The process of producing batch records by implementing an EBRS and the benefits derived can be stated simply as automate, validate, reduce errors and streamline the review process. However, there are many factors to consider when implementing an EBRS. In addition to the business needs described earlier, consideration must be given whether to upgrade an existing system or install a new system (either to replace or to supplement the existing system), and the validation impact of the system architecture selected. User and functional requirements should be defined early in the project by a multidisciplinary team, which should include representatives from the quality assurance (QA), IT, validation and manufacturing departments.


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