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Process Management and Compliance
Transform the lab-to-commercialization process and deliver up to 10x reduction in compliance risk, 25% productivity improvement and 50% decrease in cycle times.
Transforming Batch Records through
Paper Free and Automated Execution
Accelrys Electronic Batch Records (formerly VelQuest SmartBatch 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. Accelrys EBR is designed for organizations that want improved batch record keeping and compliance without the large overheads of a complex MES system.
By automating documentation and data review activities, Accelrys EBR can help manufacturing operators and managers as well as QA data reviewers:
Save time with right first time data collection
Minimize 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 organization
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. Delays in releasing to market and erroneous release of defective products to the market can have expensive and potentially devastating consequences.
Automating the execution and review of batch records can bring significant compliance and cost saving benefits to any manufacturer in GMP-regulated industries. Our 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
Accelrys Electronic Batch Records is included in the Accelrys Process Management and Compliance Suite, a comprehensive informatics platform for capturing, managing, and analyzing development and process data for operational excellence in new product development and commercial quality operations.
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