Electronic Batch Record is your business’ Backbone
The problems with this are self-evident and many man hours are wasted in compiling blank batch record files, then completing them during the manufacturing process and finally inspecting and approving these files during the quality control process. The problem is further compounded when you take into account requirements for storage of EBR/DHR files for up to 20 years and requirements to retrieve random files from the store for inspections and audits. Paper based EBR/DHR record systems are themselves a primary obstacle to scaling and growth in a company or manufacturing site.
The Electronic Batch Record (EBR) portal is a solution to these problems. The system has been designed to easily accommodate “non-structured” and non-linear” data forms. It can link with product specification data, bill of material data and quality data to automatically configure the appropriate batch record structure and form set for a particular product.
As operators enter data into eForms within the EBR system the values entered can be automatically checked against product specification limits so that operators get immediate feedback on any problems. The system will then reconfigure relevant sample or test data forms to take additional samples if necessary. All data entries are automatically date and time stamped so you can be sure that the correct inspections are happening at the right time and place.
The system automatically maintains, in the background, an Audit Log and a Quality Log. The Audit log tracks process step items such as “who submitted a form, when it was submitted, who approved it”, and so on. The Quality Log tracks form data changes such as “who changed this data item on a form, what it was changed from, and what value was it changed to”.
The system is compliant with FDA regulation 21 CFR part 11 in relation to electronic signatures so you can be confident in relation to regulatory and customer audits.
The EBR portal makes all of your EBR/DHR data available electronically so the system comes with many standard reports and dashboards to let you see progress and problems in the manufacturing area in real time, because it links with your existing ERP and accounts systems it provides your business with a fully paperless and integrated business management solution.