InfoBatch was designed from the start to address reporting and regulatory issues facing pharmaceutical manufacturers. InfoBatch enables life sciences manufacturers to create comprehensive electronic batch records without the cost and complexity often associated with EBR. In addition, since InfoBatch can contextualize process data from virtually any source, it has proven to be a useful tool for process optimization and analytics. As a result, InfoBatch can play an important role in enabling lean manufacturing initiatives that are becoming more and more critical as the industry continues to consolidate and rationalize facilities.
InfoBatch is a value-added plug-in to third party automation systems, process historians and MES. An intuitive configuration tool enables straightforward configuration without custom programming. InfoBatch report configuration and maintenance costs have proven to be considerably less than proprietary tools generally associated with these systems. In addition, since InfoBatch is purpose-built for electronic batch reporting, validation, documentation and change control are straightforward.
Life Science Applications:
- Electronic Batch Records
- CIP/SIP Reporting
- APR Investigations
- Periodic Assessment
- Cycle Time Analysis
- “Golden Batch” Analysis
- Compatibility – InfoBatch conforms to industry standard data access protocols which ensures compatibility with most process historians, LIMS, MES, and ERP systems. The software can easily be deployed on existing information systems, thus avoiding expensive and disruptive upgrades.
- All-encompassing – InfoBatch reports can address virtually every manufacturing activity including batch release, APR investigation, morning production reports, cycle time analysis, validation studies and periodic assessment.
- Simple to configure and use – User-friendly Windows® and web browser client applications reduce training costs and encourage full utilization.
- Reports created from the source – InfoBatch does not replicate data. It retrieves data from the original source each time a report is generated, thus eliminating a point of failure associated with replication.
- Configured, not programmed – All InfoBatch configuration tasks are simple point-and-click operations. Reports are generated with less training, lower development costs and fewer errors.
- Regulatory Compliance – User security and traceability features are an integral part of the InfoBatch design, ensuring compliance with cGMP regulations and guidelines.