An electronic batch record (eBR) provides a complete manufacturing audit trail of every manufacturing batch produced. It replaces paper batch record forms with a self-auditing batch record process that eliminates costly paperwork errors and the requirement to review batch records manually. You can access electronic batch record data online and batch record throughput times are much shorter, with reduced risk of non-compliance.
Electronic batch record software helps to ensure manufacturing control by reducing scrap, batch paperwork errors and redundant checks. It offers the flexibility to model and change complex processes based on the master batch record and the real-time feedback needed to quickly identify and resolve batch record issues that inhibit process and product improvement. eBR software manages a wide variety of processes, including personalized and autologous therapies, bio-diagnostics (reagents and instruments), assays, and others.
Electronic batch records must be fully 21 CFR Part 11 compliant, with electronic signatures and full-data integrity and retention. As the system creates the electronic batch record, it enforces the master batch record. The electronic batch record features comprehensive product and process tracking and control, including processes and equipment used, quality data, test results, non-conformances, materials consumed, process yield, operator signatures, and dates and times.
Life Sciences manufacturers face daily challenges in securing and maintaining a profitable, growing business despite strict regulations, global competition, and the need for customized products. Top Pharma and Biotech companies use electronic batch record software to reduce operating and compliance costs, improve quality and consistency, and shorten time-to-volume product cycles.
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