GMP

AuditCommand

Equipment audit data collected, reviewed, and approved in one system. An automated equipment data retrieval system that routes it for electronic review and stores every record in one centralized, compliant system.
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    Closes the equipment audit trail gaps behind FDA Form 483 observations with a defensible record.

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    Equipment audit trails from HMIs, instruments, skids, and DCS systems land in one view.

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    Audit trail records are assembled as production runs, ready when the batch finishes.

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    Equipment data is collected automatically, the same way, from every connected system.

Trusted By

One automated system for collection, routing, and approval

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Automatic Collection

Connects directly to equipment: HMIs, skids, instruments, DCS systems, historians with out-of-the-box connectors to eliminate custom scripting. Your data stays on-premise.

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Intelligent Report Generation

Validation rules turn raw equipment data into audit trail documentation reviewers can read. Records are generated automatically at batch completion.

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Approve and Centralize

Records route for role-based review, annotation, and signature. Every action logs with a timestamp and user identity. Approved records live in one compliant repository.

Data Collection & Unification

Connects directly to existing automation systems: equipment skids, HMIs, instruments, DCS, historians. Extracts audit trail data without requiring a centralized data lake or cloud platform.

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Automatic Report Generation

Audit trail records are generated automatically at batch completion or on a defined schedule. Records are available for review immediately and are not dependent on manual initiation.
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Data Transformation

Raw data from isolated sources is processed and contextualized according to specified validation rules. Fragmented operational records become structured, meaningful audit trail documentation.
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Review and Approval Routing

Completed records are routed electronically for review and approval. Routing logic supports role-based review, escalation, and multi-site deployment. Every action is logged with a timestamp and user identity.
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CFR Part 11 Compliance

Electronic signatures, audit trail logging, and secure record storage meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures.
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Configurable Report Scope

Report templates can be configured to include relevant audit trail events while filtering out records that do not require review. Keeps the review process manageable without sacrificing coverage.
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Operates at the Automation Layer

Runs close to the OT layer, processing data at the source. Eliminates latency, reduces integration complexity, and avoids moving regulated manufacturing data off-premise.

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End-to-End Audit System

Handles both data extraction and review approval in one solution. Most facilities manage these functions separately with no guaranteed connection between generation and approval.
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Eliminates Custom Scripting

Connects to equipment using a robust library of out-of-the-box connectors. Competitors typically require custom integration work, adding cost and timeline risk.
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Extensive Equipment Library

Pre-built connections to HMIs, instruments, skids, and DCS systems across vendors. Minimal configuration required to deploy.
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Developed for GMP

Built by a leading GMP Manufacturing Intelligence team. Already deployed at nine of the top ten global pharmaceutical manufacturers.
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Reduced Validation Scope

Pre-configured solution. Validation scope is defined upfront, not a rolling conversation with every system change.
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Equipment Integration and Data Acquisition

AuditCommand connects at the automation layer and reads audit trail data directly from the equipment already on your floor. New or legacy, no equipment is out of scope.

  • Direct connections to skids, HMIs, instruments, DCS systems, and historians
  • Real-time synchronization across devices, so events from separate systems line up on one timeline
  • Connections built against your equipment list, including older systems with no native export
  • No data lake, no cloud platform, no custom scripting
  • Regulated data stays on premise
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Review Workflow and Approval Management

Route every event, or only the exceptions that need attention. You define the review scope.

  • Risk-based and exception-based review, configurable by equipment, batch, or event type
  • Full-event routing where complete review is required
  • Role-based routing with annotation, escalation, and multi-stage approval
  • Records generate automatically at batch completion or on a defined schedule
  • Real-time status across every batch in review
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Compliance and Data Integrity

Records are built to hold up under inspection. So is the review process itself.

  • 21 CFR Part 11 compliant electronic signatures and record handling
  • Every review action logged with timestamp and user identity
  • AuditCommand maintains its own audit trail of all review and approval activity
  • Role-based access control across review and approval stages
  • Approved records centralized in one auditable repository
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Validation, Architecture, and Deployment

GAMP 5 Category 4. Configured, not custom, with a revalidation scope your team can manage.

  • Classified as a GAMP 5 Category 4 configured product
  • Software is pretested before deployment
  • Datacor supplies supporting documentation for your validation process
  • On-premise architecture at the automation layer, with no cloud dependency

  • Scales from a single manufacturing area to multi-site deployment

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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 AuditCommand to the equipment and systems already running on your floor, with no new infrastructure and no custom development.

Equipment and Control Systems

Read audit trail data directly from skids, HMIs, instruments, and PLCs at the automation layer.

Historians and Data Platforms

Pull from process historians, SQL sources, and file-based exports without a data lake or cloud platform.

Utilities and Environmental Monitoring

Capture audit trail data from cleanroom, HVAC, water, and environmental monitoring systems alongside production equipment.

Legacy and Custom Equipment

No equipment is out of scope. Datacor builds connections against your equipment list, including older systems with no native export.

Potential Results

Explore Customer Stories
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4-8 hrs Manual Collection

Time engineers spend pulling audit data from equipment, returned to engineering work.

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50-70% Data Integrity Findings

Automated collection removes the manual errors that drive review findings.

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1 day Record Availability

Records are waiting at batch completion instead of being assembled by hand afterward.

Built for Regulated Manufacturing Teams

Designed for manufacturers who are still pulling audit trail data from equipment by hand.

Your team can now access get one unbroken, defensible record from equipment to approval, ready for inspection with zero audit trail observations.

FAQ

Adding a system to a validated environment raises questions about scope, integration, and compliance. Here's what you need to know about AuditCommand.

Do we need a data lake or cloud platform?

No. AuditCommand operates at the automation layer and processes data at the source. Regulated manufacturing data stays on-premise, which avoids both latency and the data governance exposure of moving records off-site.

Will we need custom scripting or integration development?

Standard equipment connections are pre-built. Competing approaches typically require custom integration work for each data source, which adds cost and timeline risk.

Does Audit Command replace our MES, historian, or ERP?

No. It pulls from the systems already in place and adds the audit trail generation and review layer on top.

Is Audit Command 21 CFR Part 11 compliant?

Yes. Electronic signatures, audit trail logging, and secure record storage meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. Every review action is logged with a timestamp and user identity.

How does the review and approval workflow work?

Records generate automatically at batch completion or on a defined schedule, then route electronically for review, annotation, and signature. Routing logic supports role-based review, escalation, and multi-site deployment.

What is our revalidation burden?

AuditCommand is a supported, pre-configured product rather than a custom-built tool, so revalidation scope is defined instead of open-ended. Facilities maintaining their own reporting tools carry revalidation work with every change to a data source, template, or configuration.

Can we control what appears in a report?

Yes. Report templates can be configured to include the audit trail events that require review and filter out the records that do not, keeping review volume manageable without cutting coverage.

How does this reduce inspection risk?

Audit trail gaps are a known source of FDA Form 483 observations. Manual collection carries structural risk that better documentation alone cannot fix. AuditCommand produces structured, consistent records automatically, so the process holds up when an auditor asks how equipment audit trails get reviewed.

Can it scale across multiple sites?

Yes. Deployments commonly start at a single site, then expand across manufacturing areas and additional sites. Routing logic supports multi-site review structures.
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Talk to our team about automating equipment audit trail review at your site.

Request a Demo
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