Transforming Batch Records through Paper Free and Automated Execution
BIOVIA EBR is an out of the box procedure execution and electronic batch record software system designed to provide a low cost of ownership electronic environment to efficiently and compliantly document the execution of any procedure or recipe. Small to midsize life science companies under regulatory guidelines and requiring compliant operations often lack the financial and human resources required to support full-scale electronic management and automation such as a Manufacturing Execution System (MES) for batch operations. BIOVIA EBR is designed for organisations that want improved batch record keeping and compliance without the large overheads of a complex MES system.
Automating the execution and review of batch records can bring significant compliance and cost saving benefits to any manufacturer in GMP-regulated industries. Capabilities include:
- On-screen access to current batch record
- 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
By automating documentation and data review activities, BIOVIA EBR can help manufacturing operators and managers as well as QA data reviewers:
- Save time with right first time data collection
- Minimise reworks and investigations
- Cut review time in half with review by exception
- Reduce overall cycle times to release products
- Reduce warehouse inventories
- Access trending, productivity and other metrics instantly
- Maintain consistency with use of most current version of Batch Records throughout organisation
