These industries include Pharmaceuticals, Food & Beverage, CPG, and Chemical, where the production process must be carefully controlled for both quality and efficiency. These processes can be hindered by paper-based workflows, which take additional time, and may be inaccurate.
TrakSYS offers versatile recipe and Batch Management capabilities designed for executing batching operations in both automated and manual operations. TrakSYS follows ISA-88 standards and makes it possible to manage recipes, execute batch functions, enforce SOPs/tasks, allocate assets, and track materials and labor. A complete electronic audit trail of transactions can be available to meet 21 CFR Part 11 Compliance, cGMP, and the most stringent EBR requirements.
Configure recipes and procedures, or interface with information stored in ERP to provide the shop floor with instructions for how to complete the batch.
Define batch functions, sequential/parallel steps, and tasks (e.g. setup, manual checks, quality checks, sign-off, etc.) to enforce standard procedures.
Connected to existing automation infrastructure, TrakSYS provides a clear view of what is happening on the plant floor and informs of events requiring attention. TrakSYS records specific causes of delays and overages and analyzes the trends to determine how to reproduce your golden batch.
Connect to automation to record and retrieve time-series production and process data. Data Historian further enhances Traceability, enabling users to analyze sources of variation, identify process improvement opportunities, and quickly troubleshoot root causes.
Track suppliers, lot numbers, and quality parameters to provide traceability and benchmark supplier performance. Record material consumption and interface with ERP and WMS to maintain inventory accuracy. Track labor to benchmark performance and establish Best Practices.
Using extensive analytics, workflow engine, and dashboards of TrakSYS, detailed user-definable reports and electronic batch records (EBRs) can be generated with ease. A complete electronic audit trail of your transactions can be available to meet 21 CFR Part 11 Compliance and the most stringent EBR requirements.
Web-based configuration tools and an integrated scripting environment allow the construction of tailored solutions without the need for custom code.
TrakSYS is a full MOM platform, with standard function libraries that can be readily adjusted to create focused solutions in a fraction of the time compared to traditional development. This important functionality delivers both rapid deployment and cost-effective extensibility.