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
Reduce
Ensure Batch
Comply with RegulationsTrakSYS helps life sciences manufacturers enable operational excellence initiatives, meet safety compliance requirements, and support sustainability efforts. Here’s how:
TrakSYS defines necessary materials needed, coordinates with your Enterprise Resource Planning (ERP) system, and traces your materials to their lots and suppliers.
Automate your record keeping, including changes, actions, recorded values, and electronic signatures, for the creation of a comprehensive audit trail.
Improve quality with Statistical Process Control (SPC) and real-time data, to respond to out-of-compliance events.
Eliminate paperwork with digitally-managed Standard Operating Procedures (SOPs), including full archiving for regulatory compliance.
Increase productivity through measurement such as OEE and TEEP, and automated corrective and preventive action using tasks and journals.
TrakSYS has been deployed at thousands of factories in over 100 countries, including many leading life sciences manufacturers.
Want to learn more about TrakSYS for Life Sciences? Check out these handy documents.
Case Study
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
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
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.