Electronic Batch Records

Traditionally, most pharmaceutical companies used paper records to maintain production batch records, commonly known as production batch master records. However, this method of documentation has numerous shortcomings. In 1997, the FDA accepted electronic batch records in pharmaceuticals after EBR systems became FDA compliant.

Pharmaceutical companies are required to adopt the use of automated electronic batch records to ensure they comply with current FDA good manufacturing practice standards. Electronic Lot Records (EBRs) provide evidence that each batch of pharmaceuticals was handled correctly during the production process.

EBR software can be designed to perform various operations, including: calculations and routine data integrity checks. Routine integrity checks facilitate automatic tracking of information in pharmaceutical companies. Basically, the software tracks every piece of information entered into electronic forms. Therefore, batch coordinators can easily keep track of the processing of each batch. This software can also be programmed to perform simple and complex arithmetic operations.

Pharmaceutical companies can document the dates of the batches, their respective weights, the components of each batch, as well as all the people involved in the processing and handling of each batch. This information is recorded and stored in an encrypted form in Electronic Batch Records, which guarantees the privacy and security of the data.

Previously, paper forms systems were associated with problems such as incorrect data entry. Electronic batch recording systems are designed to accurately capture data. The EBR software is designed with pre-configured forms that provide options that have been pre-entered into the form fields. This ensures accurate data entry into electronic batch records.

Manual batch operations are basically error prone, very slow and slow. Electronic batch records can be used as an alternative to facilitate automated batch operations, improving the efficiency of the overall process for each batch. With Master Control, EBRs can automate the escalation and routing of manufacturing batch records to ensure batch management efficiencies.

The electronic batch registration system is a peripheral part of the integrated Master Control unit. In this unit, electronic batch records can be connected to other Master Control applications that are designed to control quality processes. Customer complaints, for example, can be correlated with production data in electronic batch manufacturing records to ensure quality improvement.

It can be time consuming trying to physically track records and laboratory test results without the use of electronic batch records. Bottlenecks may not be avoided when using manual processes such as paper forms systems. However, electronic logging software ensures automatic data tracking that allows bottlenecks to be identified. If bottlenecks are identified early enough, they can be prevented before they cause significant problems within pharmaceutical organizations.

More importantly, an analysis reporting tool can be incorporated into the electronic batch records for complete analysis and reporting of system processes. Most electronic batch records have a built-in analysis tool that has preconfigured reports. The end user can customize and adjust these reports to facilitate analysis and evaluation of batch processing.

Therefore, electronic batch manufacturing records in pharmaceutical companies are indispensable when it comes to keeping records about batch processing of pharmaceutical products.

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