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TrakSYS for Life Sciences

Just What the Doctor Ordered
TrakSYS MES and EBR software for pharma and life sciences manufacturers

Trusted by Leading Pharmaceutical, Biotech, and Medical Manufacturers Worldwide

TrakSYS MES software has been deployed at thousands of factories in over 100 countries, including many leading pharma and life sciences manufacturers.

astrazeneca
bristol
bayer
johnsons
glaxosmithkline
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The Prescription for a More Productive and Profitable Operation

As a life sciences manufacturer — including pharmaceuticals, biotechnology, and medical devices — you operate in a high-volume environment where quality is paramount. After all, the value of your brand is tied closely to the quality of just one or several products. In addition, you must conform to strict regulations, such as US FDA 21 CFR Part 11 and European Annex 11, and follow current Good Manufacturing Practices (cGMP). You’re focused on optimizing operations, to increase quality and productivity, and add a few more points to the bottom line. TrakSYS can help.

Improve Total Product Quality
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Reduce Production Costs
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Ensure Complete Batch Safety
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Comply With Regulations
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How TrakSYS Helps You Gain Greater Visibility, Knowledge, and Control

TrakSYS MES software helps pharmaceutical and other life sciences manufacturers enable operational excellence initiatives, meet safety compliance requirements, and support sustainability efforts. Here’s how:

Batch Recipe Management​

TrakSYS defines necessary materials needed, coordinates with your Enterprise Resource Planning (ERP) system, and traces your materials to their lots and suppliers.

Integrate TrakSYS with automated material dispensing systems to ensure each batch is comprised of the appropriate amount of a given ingredient.

Track how much usable product is generated from each batch and use historical records to see how or where improvements can be made to maximize output.
Log ingredient details including supplier, lot number, and exact usage quantities to facilitate potential recalls and/or audits.
Optimize batch scheduling by analyzing production capacity, equipment availability, and inventory levels.

Electronic Records

TrakSYS offers comprehensive electronic records solutions, including Electronic Batch Records (EBRs) and Electronic Device History Records (eDHRs), designed to help pharmaceutical, life sciences, and medical device companies work more efficiently. Whether you’re managing batch processes or discrete manufacturing, TrakSYS automates critical record-keeping tasks—capturing changes, actions, recorded values, and electronic signatures—to create a complete, compliant audit trail at every stage of production.

Ensure a clear audit trail for all actions within the manufacturing process.

Set permission controls, encrypt EBRs, integrate with electronic signature systems, and ensure data integrity.
Streamline recipe management with controlled EBR revisions, automatic change orders, and real-time notifications for production staff.

SOP Implementation

Eliminate paperwork with digitally-managed Standard Operating Procedures (SOPs), including full archiving for regulatory compliance.

Capture accurate, real-time production data by integrating TrakSYS into existing systems or by using TrakSYS smart devices.

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Standardize aseptic processing, provide disinfection protocols, and provide your production staff with a centralized repository for SOP’s.
Digitalized SOPs ensure that training documents and modules are always up-to-date and readily accessible.

Increased Productivity

Increase productivity through measurement such as OEE and TEEP, and automated corrective and preventive action using tasks and journals.
When preset production parameters are broken, relevant personnel are notified to ensure immediate intervention.
Dynamically adapt to unexpected events with automatic batch production rescheduling.
Leverage IoT predictive maintenance to monitor and automatically trigger alerts and generate work orders for machines that need upkeep.

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What are You Working on Right Now?

Performance? Quality? E-Records? Tell us what you’re working on.
Chances are, we can help.

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