TrakSYS for Life Sciences
Just What the Doctor Ordered
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.
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 Quality
Reduce Cost
Ensure Batch Safety
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.
What are You Working on Right Now?
Performance? Quality? E-Records? Tell us what you’re working on. Chances are, we can help.