Electronic Batch Records
Manufacturers in GMP regulated industries have traditionally relied on paper-based manual processes to document execution of production batch records. Paper-based documentation of executed batch record activities is prone to transcription and calculation errors. Manual review and approval of paper batch records is burdened with non-value added tasks at every step. Erroneous release of defective product to the market can have expensive.
Automating the execution and review of batch records can bring significant compliance and cost saving benefits to any manufacturer in GMP regulated industries.
SmartBatch EBR is a procedure execution and electronic batch record software system used to electronically document execution of any procedure or recipe. Small to midsize life science companies are under the same FDA scrutiny as big pharma, but lack the financial and human resources required to support full-scale MES automation.
By automating documentation and data review activities, SmartBatch EBR can help manufacturing operators and managers as well as QA data reviewers save time in day to day work, and reduce overall cycle times to release product. Savings of over 50% can be realized in areas of data capture, document preparation, and QA data review.
- On-screen access to current batch recordPaperless Batch Record execution and data capture
- Step control with step-based work instructions
- Qualification checks on all equipment and materials used
- Automated data capture from equipment and devices
- Real-time limit checking
- Automated calculations
- Forced authentication
- Forced sequencing
- Electronic signatures
- Data review dashboard for 'review by exception'
- Compliance flags indicating non-conforming data values
- Audit trails with operator identification and date/time stamp
- Trending reports and batch certificates
- Export data to external systems such as MES and ERP