You’re gaining ground and advancing science with every step. It’s a lot of pressure, but you’ve got the knowledge, and we’re here to help you keep going—we believe in you. It’s why we support you with superior services, remote tools, training, and OEM expertise that we’ve spent over 40 years curating. By getting the most out of your Applied Biosystems, Invitrogen, and Ion Torrent instruments and applications, you can maintain your focus where it needs to be: making a positive impact for generations to come. Our solutions help address your needs, so you can keep conquering disease.
cGMP (current Good Manufacturing Practice) refers to the set of regulations enforced by U.S. FDA (Food and Drug Administration), and it includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
Qualification services (installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and instrument performance verification (IPV)) address the following:
Computer System Validation (CSV) addresses the following CFR:
Every minute counts when you are conquering disease and you can’t afford to compromise quality on your way to result. Our instrument service plans can help ensure reliability and consistency in your work by providing fast on-site response* and issue resolution.
Our choice of instrument service plans includes the following:
Our professional services help meet your needs in the following ways:
*Fast on-site response is subject to regional availability.
**Availability limited in some geographic areas.
Product sterility and purity are critically important when it comes to the manufacturing phase. The Applied Biosystems MicroSEQ Microbial Identification System is used for environmental monitoring, contamination investigation, root cause analysis, raw materials testing, and microbial identification in small-molecule and biopharmaceutical manufacturing and service laboratories. Our CSV consulting service helps strengthen the MicroSEQ system.
Our CSV consulting service directly supports the MicroSEQ system in the following way:
Computer system validation (CSV)—help save time and control costs when you engage our specialists to guide you through the validation process documenting your data security, auditing, and e-signature software features.
Download the Good Automated Manufacturing Practice (GAMP™) 5 guide for validation of automated systems in pharmaceutical manufacture.