InfoBatch
Generate complete, release-ready batch records automatically from the historian, LIMS, and MES data you already have, cutting validation cost by up to 75% with no replication layer and no custom code.
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Records auto-generate and arrive in the review queue at batch completion, and exception-based review helps focus on what needs attention.
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Validation cost and effort drop by up to 75%. There is no secondary database in the reporting path, so there is nothing extra to qualify, reconcile, or revalidate at every upgrade.
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Every value in the record traces back to its source system, timestamp, and reviewer. Electronic signatures, role-based access, and a complete audit trail are built into the architecture.
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Your automation stays in place, your team owns the record configuration, and one reporting standard scales from a single manufacturing area to a global network.
Built for Regulated Manufacturing at Scale
Data is queried from your automation systems, historian, and LIMS at generation time. Nothing is copied first, so nothing extra sits in your validation scope.
Your engineers build and update records in a point-and-click configurator, without a developer queue, a vendor change order, or a validation cycle.
Each piece of data traces to its source system, timestamp, and reviewer. Inspectors get answers from the system, not from someone's recollection.
The Batch Documentation Problems Every Regulated Manufacturer Faces
Production Data Lives in Systems Built to Control, Not to Report
Your DCS runs the process. Your historian stores the trend data. Your LIMS holds in-process and release testing. Your MES tracks execution, and your ERP carries material genealogy. Each system does its job well, and none of them was designed to produce a compliant batch record. The gap between process control and compliance documentation is filled by people.
Quality Teams Assemble Records by Hand
Analysts copy values out of the historian, cross-check them against LIMS results, and paste them into Word templates or Excel workbooks. A single batch can consume three to four hours of skilled quality time before review even begins. Every manual transfer is an opportunity for a transcription error to enter a document that a regulator will later read line by line.
Custom Reporting Is Expensive to Build and Harder to Keep
Reporting tools bundled with a DCS or MES platform tie you to one automation vendor and one data model. Custom-coded solutions carry the same problem with added maintenance risk. Both break at system upgrade, both require developer time to change, and both trigger a fresh validation cycle every time they move.
Part 11 Requirements Are Difficult to Meet in General-Purpose Tools
21 CFR Part 11 requires authentication, controlled access, electronic signature binding, and a secure, computer-generated, time-stamped audit trail. Word documents, spreadsheets, and network shares provide none of these. FDA investigators increasingly ask where a value came from, who changed it, and whether the change was approved. Records assembled in office software cannot answer those questions.
Every Recipe Change Restarts the Development and Validation Cycle
Paper Review Workflows Delay Release
How InfoBatch Builds the Record
Native Connectivity Across the Automation Stack
InfoBatch connects to Emerson DeltaV and Syncade, AVEVA PI, OPC HDA, ODBC data sources, LIMS, MES, and ERP through preconfigured connectors. Connection is a configuration exercise, not an integration project, and no middleware layer sits between InfoBatch and your systems of record.
Data Is Read From the Source at Generation Time
When a record is generated, InfoBatch queries each source system directly and pulls the current values. Nothing is staged in an intermediate database, so there is no synchronization schedule to monitor, no drift between the copy and the original, and no second data store to qualify. The record reflects what the source systems contain at the moment it was produced.
Manufacturing Context Is Applied Automatically
Raw tags and timestamps do not constitute a batch record. InfoBatch data models apply plant hierarchy, equipment, phase, unit procedure, and batch context to every data point as it is retrieved. Values arrive in the record already associated with the step that produced them.
Code-Free Configuration Mirrored to Your Plant Hierarchy
Record configuration happens in a structured point-and-click interface organized the way your facility is organized. Quality and process engineering staff who understand the product build the record. Configuration is version-controlled and change-managed inside the application rather than in files on a network drive.
A Reusable Library Instead of Duplicated Templates
AutoGen Generates Records on Batch Completion
Exception Reporting Focuses Review on What Matters
Review, Approval, Archive, and Version Control Under Part 11
Batch, Semi-Continuous, and Continuous Manufacturing
Batch Record Generation and Compliance Management
Data Connectivity and Aggregation
InfoBatch reads from the systems already running your process. Nothing is copied into an intermediate store first.
- Preconfigured connectors for Emerson DeltaV and Syncade, including co-installation with DeltaV Application Stations
- AVEVA PI, OPC HDA, and ODBC-compatible data sources
- LIMS, MES, and ERP connectivity for in-process results, execution data, and material genealogy
- File-based instrument, skid, and HMI data through InfoETL, covering CSV, XML, SQLite, and JSON with no scripting
- Data retrieved from each source at generation time, with no replication layer, no middleware, and no synchronization schedule to monitor
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Genealogy licensing connects multiple Batch Historians and MES sources to a single InfoBatch server
Record Configuration and Reuse
Configuration is owned by the people who understand the product, not by a development queue.
- Point-and-click configurator organized to mirror your plant hierarchy
- Record configuration performed without code and without vendor change orders
- Library Manager stores reusable record sections as shared components
- A change to a shared element propagates to every record that uses it
- Version-controlled, auditable configuration managed inside the application rather than in files on a network drive
- Backward compatibility maintained across releases, so upgrades do not break existing configurations
Automated Generation and Exception-Based Review
Records are produced on the event, and reviewers see what needs attention rather than everything.
- AutoGen triggers finished records on batch completion events and pushes them to review queues
- Scheduled and on-demand generation for periodic assessment, certificates of analysis, and cycle time reporting
- Automatic limit monitoring surfaces excursions and quality deviations
- Exception-based review focuses attention on out-of-limit results instead of full-record reading
- Multi-thousand-page records with rich embedded content, generated in minutes
- Report generation improvements of 83% to 98% against prior manual and custom-built approaches
Compliance and Data Integrity
Records are built to hold up under inspection, and so is the process that produced them.
- 21 CFR Part 11 electronic signatures bound to their records
- Secure, computer-generated, time-stamped audit trail across generation, review, approval, and archive
- Unique user authentication and role-based access control at every stage
- Full version control, with prior versions retrievable for the retention period your regulators require
- Data provenance traceable to the source system, tag, and retrieval timestamp for every value in the record
- Electronic review and approval routing that replaces paper folder circulation
Validation, Architecture, and Deployment
Purpose-built for GMP, with a validated footprint smaller than the tools it replaces.
- Purpose-built GMP product with IQ/OQ/PQ documentation support
Validation cost and effort reduced by up to -
75% compared with proprietary tools bundled into DCS and MES platforms
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No secondary database in the reporting path, which removes it from validation scope
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Configuration changes managed under change control and qualified as configuration
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Server-based deployment on dedicated or virtual servers, sized for high-volume enterprise use
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Browser-based multi-user web client, plus a Web API for programmatic access and third-party integration
- Scales from a single manufacturing area to a multi-site network on one reporting standard
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More than 20 years in production at compliance-critical sites, with continuous improvement and no product end-of-life
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Built for Regulated Manufacturing at Scale
Designed for GMP manufacturers running complex, multi-system automation environments.
Large commercial pharmaceutical operations run DCS, MES, historian, LIMS, and ERP systems that were selected at different times for different reasons. Batch documentation has to span all of them, satisfy 21 CFR Part 11 and EU GMP Annex 11, and hold up under inspection. InfoBatch is built for that environment: high record volumes, multi-thousand page records, multiple sites, and quality organizations that cannot absorb another validation burden.
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