GMP

InfoBatch^®

Automatically generate release-ready batch records from automation, historian, LIMS, and MES data you already have. Simplify compliance documentation, production reporting, and process analytics in regulated environments.

Records are generated automatically or on-demand, ensuring that critical information is available throughout batch execution.
Your infrastructure stays in place, your team owns the record configuration, and one reporting standard scales from a single manufacturing area to a global network.
The solution enforces data integrity to ensure compliance with 21 CFR Part 11 and EU Annex 11.
Electronic signatures, role-based access, and a complete audit trail provide the traceability required in a regulated environment.
The InfoBatch Library Manager creates reusable report configurations, streamlining standardization across areas, sites, and enterprises.

Trusted By

No Repository In Between

Data is queried from your automation systems, historian, MES, and LIMS at report generation time. No redundant data storage that requires validation and maintenance.

Configured, Not Coded

Your engineers build and update records in a point-and-click configurator, without a developer queue or a vendor change order.

Replace Fragile Reporting Systems

Leading Life Science manufacturers turn to InfoBatch to replace unmanageable systems that become costly, complex, and unreliable.

Production Data Lives in Systems Built to Control, Not to Report

Your automation systems run the process. Your historians store the 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, but none of them was designed to produce a compliant batch record that spans all of these systems.

Quality Teams Assemble Records Using Disparate Systems

A single batch can consume hours of skilled quality analyst time before formal review even begins. Every manual activity is an opportunity for error.

Custom Reporting Is Expensive to Build and Harder to Keep

Reporting tools bundled with proprietary manufacturing systems tie you to one vendor and one data model. Custom-coded solutions introduce another set of problems with added maintenance risk.

Regulatory Requirements Are Difficult to Meet with General-Purpose Tools

21 CFR Part 11 and EU Annex 11 require authentication, controlled access, electronic signature binding, and a secure, computer-generated, time-stamped audit trail. Agency investigators increasingly ask where a value came from, who changed it, and whether the change was approved. Records assembled in general-purpose software cannot answer those questions.

Every Recipe Change Restarts the Development and Validation Cycle

Add a critical quality attribute, revise a recipe, or bring a new data source online, and the reporting configuration has to change with it. When that configuration is code, the change requires a developer, a change order, and extensive revalidation. Process improvements stall behind documentation work.

Paper Review Workflows Delay Release

Physical folders move department to department for signature. Review status is invisible until someone walks the hallway to find the binder. Batches that finished production days ago sit unreleased while paperwork completes its route. Inventory ages, and time to market slips.

Native Connectivity Across the Automation Stack

InfoBatch connects to DeltaV and Syncade, Rockwell FactoryTalk, historians, MES, LIMS, 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 appropriate historical values. Nothing is staged in an intermediate database, so there is no synchronization schedule to monitor, no disparity between the copy and the original, and no second data store to qualify. The record reflects what the source systems contain at the moment the batch 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 process is structured. Quality and engineering staff who understand the process 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

Library Manager stores pre-configured record sections as shared components. New reports are assembled from existing sections, and a change to a shared element propagates everywhere it is used. Configuration effort drops across product families, process variants, and sites.

AutoGen^™ Generates Records on Batch Completion

The InfoBatch AutoGen™ module listens for batch completion events and produces the finished record automatically, then pushes it into the review queue. Production closes and the record is already waiting for the reviewer. No one needs to requests it, and no one assembles it.

Exception Reporting Focuses Review on What Matters

InfoBatch monitors limits and automatically surfaces exceptions and quality deviations. Reviewers open a record that already identifies where attention is needed instead of reading several hundred pages. Review by exception is what turns a multi-day review into a same-day review.

Audit-Ready Review, Approval, Archive, and Version Control

Records route through electronic review and approval with bound electronic signatures. Every generation, edit, review, and approval is captured in a secure, time-stamped audit trail. Prior versions remain retrievable, and archived records stay accessible for the retention period your regulators require.

Batch, Semi-Continuous, and Continuous Manufacturing

Continuous processes have no batch hierarchy for a traditional record to bracket. InfoBatch contextualizes process data across time-based, material-based, and event-based boundaries, supporting the traceability expectations described in ICH Q13 without abandoning your existing batch reporting for products that still run in campaigns.

Data Connectivity and Aggregation

InfoBatch reads from the systems already running your process. Nothing is copied into an intermediate store first.

Preconfigured connectors for industry-leading platforms such as DeltaV and Syncade, Rockwell FactoryTalk, AVEVA PI, AspenTech InfoPlus.21, and more
OPC, ODBC, and OLEDB-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
Genealogy licensing connects multiple manufacturing areas to a single InfoBatch server

Record Configuration and Reuse

Configuration is owned by the people who understand the process, 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 disks
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.

InfoBatch 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 exceptions 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 50% to 90% against prior alternative 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 and EU Annex 11 compliant 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 configuration version control, with prior versions retrievable for the retention period your regulators require
Data provenance traceable to the source system, parameter, and retrieval timestamp for every value in the record
Electronic review and approval routing that replaces the paper trail

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.
No redundant database in the reporting path, which simplifies validation and maintenance scope
Configuration managed under change control
Server-based deployment on dedicated or virtual servers, sized for high-volume enterprise use
Modern browser-based web client
Web API for programmatic access and third-party integration
Scales from a single manufacturing area to a multi-site network on one reporting standard
20+ years in production at compliance-critical sites, with continuous improvement and no product end-of-life

Potential Results

Explore Customer Stories

50-90% Faster Report generation accelerated

Records are generated instantly, compared to alternative approaches that can take hours or days.

75% Reduced Validation cost

Lower validation cost and effort compared with proprietary tools bundled with your manufacturing systems.

9 of the 10 Largest Global pharmaceutical adoption

Deployed and trusted at nine of the ten largest global pharmaceutical companies.

Built for Regulated Manufacturing at Scale

Designed for GMP manufacturers running complex, multi-system OT environments.

Large commercial pharmaceutical operations run automation, 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 need one trusted system.

Add-on Modules

Engineering extension tools that can help you quickly and efficiently complete projects. Modules can work individually or together within Fathom and your existing Fathom models.

Settling Slurry

Models the effects of pumping fluids containing settling solids using the Wilson/GIW method. Used with either Fathom or Impulse.

Goal Seek and Control

Identifies input parameters that yield desired output values and simulates control functions. Used with either Fathom or Arrow.

Extended Time Simulation

Models dynamic system behavior in steady-state flow and how critical system parameters vary over time. Used with either Fathom or Arrow.

Automated Network Sizing

Evaluates the complex interaction of system variables to reveal combinations of cost savings. Used with either Fathom or Arrow.

Chempak Database

The Chempak add-on utility provides a thermophysical database of almost 700 liquids and 600 gases with mixing capability.

Pulsation Frequency Analysis

Helps identify pipe acoustical frequencies to avoid resonance from excitation, especially in systems with positive displacement pumps and reciprocating compressors. Used with either Impulse or xStream

Integrations

Connect InfoBatch to the automation, quality, and enterprise systems already running in your facility, with no data lake, no middleware layer, and no custom development.

Process Control and Batch Systems

Preconfigured connectors for DeltaV and Syncade, Rockwell FactoryTalk, and other leading manufacturing systems.

Historians and Time-Series Data

Read from AVEVA PI, AspenTech InfoPlus.21, OPC, ODBC, and OLEDB-compatible databases at report generation time, with no replication.

Manufacturing Execution Systems

InfoBatch contextualizes and provides access to your manufacturing data from disparate systems using MES order execution steps.

Quality and Enterprise Systems

Pull in-process and release results from LIMS and material genealogy from ERP into the same record.

File-Based Instrument Sources (InfoETL)

Ingest CSV, XML, SQLite, and JSON output from instruments, skids, and HMIs that expose no OPC or ODBC interface. No custom scripting required.

Barcode Label Generation (InfoLabel)

Auto-generate 2D and 3D barcode labels with batch data encoded inline, closing the loop between the electronic record and the physical product.

Web API and Programmatic Access

Integrate InfoBatch with third-party systems and applications through a documented Web API for record generation and retrieval.

FAQ

InfoBatch connects to your existing manufacturing systems to generate compliant batch records.

What is InfoBatch?

InfoBatch is a server-based manufacturing intelligence and data contextualization suite from Datacor, built for GMP-regulated manufacturers. It connects to process historians, process automation platforms, MES, LIMS, and ERP systems and generates compliant electronic batch records by reading directly from those source systems at the time the record is produced. Authentication, electronic signatures, audit trail, and version control are built into the product architecture to support 21 CFR Part 11 and EU Annex 11 guidelines. InfoBatch has been in production at GMP manufacturing sites for 20+ years and is deployed at nine of the ten largest global pharmaceutical companies.

What systems does InfoBatch connect to?

InfoBatch includes preconfigured connectors for leading manufacturing platforms including DeltaV and Syncade, Rockwell FactoryTalk, AspenTech InfoPlus.21, AVEVA PI, OPC, OLEDB and ODBC-compatible databases, along with connectivity to LIMS, MES, and ERP systems.

For instruments, skids, and HMIs that do not expose OPC or ODBC interfaces, InfoETL ingests file-based data in CSV, XML, SQLite, and JSON formats with no custom scripting. InfoBatch is not tied to a single automation vendor, so a site running equipment from several suppliers reports through one environment.

Does InfoBatch require data replication?

No. InfoBatch retrieves data from each source system at record generation time. Most competing reporting tools stage data in a secondary database or middleware layer before a report can be produced, which creates a copy that has to be synchronized, reconciled, and validated alongside the original. InfoBatch eliminates that layer, which is a significant part of why customers see lower validation and deployment costs, as well as improved reliability.

Is InfoBatch compliant with 21 CFR Part 11 and EU Annex 11?

InfoBatch is purpose-built for GMP environments and provides the technical controls 21 CFR Part 11 and EU Annex 11 require: unique user authentication, role-based access control, electronic signatures bound to their records, secure computer-generated time-stamped audit trails, record version control, and protected archival. Datacor supports customer validation with IQ/OQ/PQ documentation. Compliance is a shared responsibility, so regulators are satisfied by the combination of these controls and your site's validated procedures around them.

Who configures and maintains InfoBatch reports?

You have options. Your team can own the configuration, utilize our extensive network of third-party integrators, or you can rely on the experts from Datacor.

Record configuration is performed through a point-and-click configurator organized to mirror your plant hierarchy, so authorized quality and engineering staff build and update records without writing code and without developer involvement. Configuration changes are version-controlled and managed under change control inside the application.

This is the meaningful difference for sites where every recipe revision or parameter change previously meant a vendor change order.

How does InfoBatch differ from an MES or an EBR module?

An MES executes manufacturing orders and workflows, directs operators, and captures actions as work is performed. InfoBatch reports on what happened across every system involved in the batch production, including the MES itself.

Sites with a mature MES use InfoBatch to unify MES data with historian, LIMS, and ERP data that the MES does not hold. Sites without an MES use InfoBatch to produce a compliant record from the systems they do have. InfoBatch begins where your automation infrastructure ends.

Does InfoBatch support continuous manufacturing?

Yes. Continuous and semi-continuous processes lack the batch start and end events that traditional batch record tools depend on. InfoBatch contextualizes process data across time-based, material-based, and event-based boundaries, which supports the traceability and documentation expectations set out in ICH Q13.

Sites running both continuous and batch-based products report from a single environment.

How does InfoBatch scale for large commercial operations?

InfoBatch is deployed on dedicated or virtual servers and is engineered for high-volume enterprise use, including multi-thousand-page records with rich embedded content. Genealogy licensing connects multiple manufacturing areas to a single InfoBatch server. Browser-based multi-user access means quality, operations, engineering, and IT work in the same system.

What does implementation involve?

Implementation begins with connector configuration to your source systems, followed by record template design in the configurator and pilot record generation against real development or production data. Because there is no replication layer to build and no custom code to write, the effort concentrates on configuration and qualification rather than integration.

Datacor's implementation team guides each phase and trains your staff to own configuration going forward. Timelines vary with the number of source systems and the complexity of your reporting requirements.