TrakSYS for
Life Sciences

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.



Ensure Batch

Comply with Regulations

How TrakSYS Helps You Gain Greater Visibility, Knowledge, and Control

TrakSYS helps 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.

Electronic Batch Records

Automate your record keeping, including changes, actions, recorded values, and electronic signatures, for the creation of a comprehensive audit trail.

Quality Assurance

Improve quality with Statistical Process Control (SPC) and real-time data, to respond to out-of-compliance events.

SOP Implementation

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

Increased Productivity

Increase productivity through measurement such as OEE and TEEP, and automated corrective and preventive action using tasks and journals.

Trusted by Leading Life Sciences Manufacturers Worldwide

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

LEARN MORE ABOUT TrakSYS for Life Sciences

Want to learn more about TrakSYS for Life Sciences? Check out these handy documents.

Case Study

Increasing Capacity without Additional Capital Investment

AstraZeneca improved flexibility, responsiveness and quality by aligning TrakSYS to DMAIC (Define, Measure, Analyze, Improve, Control) principles resulting to OEE improvements of 10-40% reported across multiple lines.

Case Study

Discovering Target Rates and Prioritizing Losses

As a global leader in vitamins and supplements, Pharmavite needed a software solution that could keep up with their growing demand and increase capacity while giving insight into their operations.

Case Study

Complexities in Compliance made simple with Modular MES

The medical device industry is often on the cutting edge of technology and innovation. To excel, Proteus needed a software solution that could unify their production workflows and unique processes.