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