Electronic batch record system

Chapter 28 Case Study 10 Electronic Batch Recording Systems... 

Later, in 1995, other very prominent and pnbhc instances of GxP noncompliance affecting compnter systems occurred. These involved a water purification plant, an integrated materials control and electronic batch record system, and a tabletting control system. These were owned and operated at the Burroughs-Wellcome plant in the U.S. and the Ciba-Geigy site in Switzerland. Defects revealed by the FDA inspection inclnded the following ... 

System Name Electronic Batch Record System ... 

Systems such as Manufacturing Execution Systems (MES) or Electronic Batch Record Systems (EBRS) that rely upon electronic identification of individuals should ensure that electronic identification/signatures are secure from abuse and falsification and that substitutes for handwritten signatures should nonetheless be as secure as conventional handwritten signatures. ... 

Ulrich Caspar joined F. Hoffmann-La Roche in 1984 as a pharmacist. He is currently responsible for an electronic batch recording system used in pharmaceutical production in Basel. 

As previously described, the use of computers and computerized systems in the pharmaceutical industry is growing at a rapid rate. Some of the systems used in the industry range in complexity from the use of personal computers for performing simple tasks (word processing, e-mail, Internet access) to the use of powerful computers in process-control applications. In addition, to help eliminate or reduce paper usage, the pharmaceutical industry has implemented a number of electronic batch record systems in drug substance and product manufacturing to keep track of process documentation. 

The architecture of the system is shown in Eigure 38.1. The system provides Electronic Batch Record (EBR) functionality interfaced to a Laboratory Information Management System (LIMS). 

Table 9 Audit trails and signatures in an electronic batch record (EBR) system...

A batch recording system is implemented. During the life cycle of a paper batch record a number of initials and signatures is recorded on the paper. Now the complete batch recording process will be supported electronically in the future without any paper printouts Question... 

The architecture of the MES application is shown in Figure 12.1. The system provides electronic batch record (EBR) functionality interfaced to a Laboratory Information Management System (LIMS). The system is a typical client-server application that has its own main funaions distributed on the LAN. The main functions are as follows ... 

Up to one-third of equipment cost, vastly depending on automation level fully automated including electronic batch recording (EBR) and integration into manufacturing execution system (MES) versus manual transfers between autonomously running unit operations... 

Narrowly focused, the tenets of 21 CFR 11 are indisputable that firms must establish and maintain the integrity of their electronic information. What has been lost is the clear indication of which electronic information the requirements apply to. In my opinion, data generated outside a computerized system, that are manipulated by that system and are ultimately available in hard copy should not be subject to this ruling. Validation of the computerized system should be more than sufficient to establish that the final documentation accurately reflects the input information. In that instance, the computerized system is little more than a tool whose functionality can be readily established, yet firms are endeavoring to assure 21 CFR 11 compliance for numerous systems in which the computer is little more than an adjunct to the cGMP activity and corresponding hard copy. Batch record preparation, SOP and test method archives, and many process equipment control systems are examples of systems in which requirements for 21 CFR 11 compliance appear excessive. A system that processes or communicates data or records and subsequently retains and stores hard copies should not be subject to the 21 CFR 11 requirements. Far too many systems are being unnecessarily held to the very restrictive portions of 21 CFR 11. Electronic record retention as defined in 21 CFR 11 has its place, but not necessarily in every computerized system used within the industry. 

The most common observation made by the FDA concerns the lack of (or incomplete) audit trails. This is often associated with the incorrect identification of electronic records. Specifically, the Warning Letters referred to Chromatography Data Systems (CDS), Electronic Document Management Systems (EDMS), Databases, Batch Records, Change Records, and Device History Records. 

Every batch record must be accessible at least for the shelf life of the drug (21 CFR 211.198 ). The introduction of the new system gives the possibility to store the batch records electronically on various storing devices such as optical disks. Compared to paper-based batch records, electronically stored records need much less room and also increase the safety of the data. 

A batch record, as stored in the database, is represented by a collection of different data on the actual production procedure and the current production enviromnent. Back in 1994, at the point of decision, the data available electronically were stored in several databases. Database update was time-consuming and difficult data analysis even needed different program interfaces. Therefore, the database for the new system had to be a central, uniform database for the whole production plant.The bill of material is fed from ERP as well as general planning. LIMS is another interface for the input of analytical data that is important in the calculation of correction factors for the content of API. 

The parameter settings are stored in the system and are considered to be electronic records, but they can be considered to have low impact on the product quality. There is a monitoring system in place that controls whether the required environmental conditions are met, and for the evaluation of the product quality during the batch record review, only the results of the monitoring systems are included... 

There is no need to implement an audit trail for the parameter settings, but the completeness of the logbook entries must be ensured, e.g., via double check and/or additional training of the employees. Nevertheless, the data in the monitoring system must be assessed regarding their Part 11 relevance. In this case all data are printed, and the printout is used for the batch record review. There is no further regulated activity based on the electronic data... 

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