Achieve Golden Batches, Every Time

TrakSYS empowers manufacturers to execute batch operations with precision and compliance. Whether your processes are automated, manual, or hybrid, TrakSYS provides the tools to manage recipes, enforce SOPs, and maintain complete traceability—all aligned with ISA-88 standards.

Batch Excellence Starts Here

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Batch Excellence Requires More Than Just Recipes

In industries where batch consistency and regulatory compliance are paramount, TrakSYS offers a comprehensive solution.

Digitize and enforce recipe execution steps.

Capture real-time data for Electronic Batch Records (EBRs).

Monitor critical parameters to ensure quality.

Maintain full traceability of materials and processes.

TrakSYS gives you the confidence to meet compliance and production goals—without trade-offs.

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TrakSYS-Powered Compliance

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TrakSYS-Powered Compliance

Regulatory pressure doesn't ease up, and neither should your traceability. See how TrakSYS gives manufacturers the audit-ready records, electronic signatures, and closed-loop controls needed to meet FDA, GMP, and ISO requirements without slowing down the line.

What is inside

Electronic batch records and e-signatures built for 21 CFR Part 11 and Part 820

Real-time non-conformance alerts with root-cause context

Configurable audit trails across users, actions, and system changes

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Comprehensive Batch Management Capabilities

Recipe Management

Configure recipes and procedures, or integrate with ERP systems to provide the shop floor with precise instructions for batch completion.

Pre-Weigh & Execute Batch Steps

Define batch functions, sequential/parallel steps, and tasks (e.g., setup, manual checks, quality checks, sign-off) to enforce standard procedures.

Track and Manage Events and Overages

Gain a clear view of plant floor activities, record specific causes of delays and overages, and analyze trends to reproduce your golden batch.

Monitor Critical Parameters

Connect to automation systems to record and retrieve time-series production and process data, enhancing traceability and enabling root cause analysis.

Track Material Consumption

Monitor suppliers, lot numbers, and quality parameters to ensure traceability and benchmark supplier performance.

Metrics & Reporting

Utilize TrakSYS’s analytics and dashboards to generate detailed, user-definable reports and EBRs, ensuring compliance with 21 CFR Part 11 and cGMP requirements.

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Real-World Results: How Amorim Standardized Batch Execution Across 25 Global Sites

Discover how the world’s largest cork producer used TrakSYS to automate recipes, eliminate errors, and bring consistency to every batch—globally.

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Your Partner in Batch Management

From recipe management to compliance reporting, TrakSYS provides a scalable, configurable platform to meet your batch processing needs.

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