You still need more details? No problem...
Letting our experts help you achieve your goals in managing your temperature sensivity assets is also our goal...
Yes, likely a professional who knows what you are looking for & why you need It. On this page we try to address common questions but are always eager to hear from you.
Call us at (830)-438-0395
Letting our experts help you achieve your goals in managing your temperature sensivity assets is also our goal...
If someone says, "Our system is validated" we encourage you to ask, "To what standard is it validated?"
We are experts in Quality Assurance. Having worked for and advised government agencies, private clients, and industry groups regarding the compliance of data acquisition and the use of the electronic data record as our best indicator regarding events with potentially negative impact on product quality. Temperature monitoring, when combined with your inventory control records, correlates a data point as evidence of a product's storage environment. There is no way for a monitoring system to know where the product is located. So by default, there is no such thing as a pre-approved "out of the box" compliant system and the CDC's VFC program does not endorse or approve commercial products.
CTS receives and distributes vaccines every day & have been audited by some of the biggest names in the BioPharma industry. Our acceptance standards are GAMP and cGMP; regarded as the "Gold Standard" for regulatory compliance allowing us to meet or exceed all other standards. A monitoring system must be designed to be integrated into your quality program and meet your acceptance standards as determined by appropriate regulatory or accreditation standards. As part of the Gold Standard, we supply you with a detailed User Acceptance Document and Installation/Operation/Performance Qualification (IOPQ) Document. This set of documents, once completed, will get your monitoring system equipment file started as proof that your monitoring system was selected and installed based on detailed specifications crosswalked to your compliance/accreditation needs. Your Calibration, Maintenance, Data Mangement, and Alarm Resolution programs combine with the User Acceptance & IOPQ to project comprehensive system of oversight needed to meet your particular regulatory compliance requirements.