Traditionally, most pharmaceutical companies used hard copy records to keep production batch records commonly known as master production batch records. However, this documentation method has numerous shortcomings. In 1997, Electronic Batch records in Pharmaceuticals were accepted by FDA after EBR systems showed compliance with FDA regulations.
Pharmaceutical companies are obliged to adopt the use of Automated Electronic Batch Records to ensure they comply with the Current Good Manufacturing Practice regulations set by FDA. Electronic Batch Records (EBRs) provide evidence that every drug product batch was properly handled during the production process.
EBR software may be designed to perform various operations which include: calculations as well as routine integrity checks of data. Routine integrity checks facilitate automatic tracking of information in pharmaceutical companies. Basically, the software tracks every piece of information fed into electronic forms. Therefore, batch coordinators can easily conduct follow-ups on the processing of each batch.This software may also be programmed to perform simple and complex arithmetic operations.
Pharmaceutical companies may document batch dates, their respective weights, components in each batch as well as all the people involved in processing and handling of each batch. This information is recorded and stored in encrypted form in Electronic Batch Records which guarantees data privacy and security.
Formerly, paper forms systems were associated with issues such as incorrect data entry. Electronic Batch Record systems are designed to accurately capture data. The EBR software is designed with pre-configured forms which provide options that were previously keyed into the form fields. This ensures accurate data entry into the Electronic Batch Records.
Manual batch operations are basically prone to error, very slow and time-consuming. Electronic batch records may be used as an alternative to facilitate automatic batch operations improving the efficiency of the overall process of each batch. With Master Control, EBRs can automate escalation and routing of batch records to ensure efficiency in the management of batch processing.
Electronic batch records system is a peripheral part of the Master Control integrated unit. In this unit, electronic batch records may be connected with other applications of the Master Control which are designed to control quality processes. Customer complaints, for example, may be correlated to production data on electronic batch records to ensure quality improvement.
It may be very time-consuming trying to physically track logs and results of laboratory tests without the use of Electronic Batch Records. Bottlenecks may not be avoided when using manual processes like paper forms systems. However, electronic records software ensure automatic data tracking which allows identification of bottlenecks. If bottlenecks are identified early enough, they may be avoided before they cause significant problems within pharmaceutical organizations.
More importantly, an analytics reporting tool may be incorporated into the electronic batch records for comprehensive analysis and reporting of system processes. Most electronic batch records have inbuilt analytics tool which has reports that are pre-configured. These reports can be customized and adjusted by the end user to facilitate effective batch processing analysis and evaluation.
Therefore electronic batch records in Pharmaceutical companies are indispensable when it comes to maintaining records on drug product batch processing.
Hey can you throw some light on the software packages for EBR and QA/QC documentation with CFR 21 compliance
ReplyDeleteKindly share software detail which has approved by FDA.
ReplyDeleteI would like to know the software suppliers for electronic batch record maintenance as well as for QA & QC.
ReplyDeleteNandan Bhandari
Maple Biotech Pvt. Ltd.
J-253, MIDC,
Bhosari
Pune 411026
India
Phone:(Works)+91 20 27130210/30628103
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(Cell) + 91 98220 18722
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E-mail: nandan@maplebiotech.co.in
Website: www.maplebiotech.co.in