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QA/QC for Drug Manufacturing
Dependable Performance Necessary to Keep Production Lines Operating
Pharmaceutical QA/QC departments are regularly subjected to tremendous business pressure. A delay in releasing a batch of drug is not only expensive but also consumes additional resources in the company. It is therefore imperative that analytical data be collected, compiled, and submitted in a timely but secure manner.
Dionex HPLC and IC system solutions provide the dependable performance and data security necessary to keep production lines operating 24/7.
Smart Start/Shutdown Facilitates System Operation
QA/QC must be supported by analytical systems that require minimal operator attention and deliver superior performance along with flawless operation for long periods of automated operation.
Dionex has responded with a new generation of innovative, intelligent solutions that are readily tailored to the varied requirements of pharmaceutical workflow. Our smart start/shutdown features built into the Chromeleon® software platform ensure that systems are ready to go when you need them. No more waiting on system warm-up at the start of a batch or flushing out at the end of one. If you are seeking better tools for drug discovery, drug manufacturing, or any step in between, Dionex has new products and enhanced services to support your pursuit of those goals.
Chromeleon Provides All the Security You Need
In gathering analytical results for regulatory submission, data security is of paramount importance. Pharmaceutical companies depend on Dionex to help them achieve compliance with the rules published by the USFDA, EMEA, and other regulatory agencies. Our customers include many of the world's largest companies, government agencies, research institutions, and universities.
The Chromeleon® software's built-in security features not only provide GLP compliance but also meet the rigorous requirements for regulatory compliance such as audit trails, electronic signatures and data files with imbedded metadata.
Dionex Proven Performance Delivers Dependability for 24/7 Operation
Efficient drug manufacturing operations demand analytical tools that reliably operate 24/7. Whether its approval of starting materials, in-process testing, product release or cleaning protocols, dependability is of the essence.
Dionex has established quality standards for every phase of our operation to maintain the highest possible level of quality. All Dionex products are designed, developed, and manufactured under a registered ISO 9001 Quality System. We also encourage customer comments and collect them from every possible source. These comments give us a reading on customer satisfaction and provide the information we need to continue finding ways to improve the quality of our products and services. The end result is an analytical solution that you can depend on.
- Liquid Chromatography
- Ion Chromatography
- Sample Preparation
- Mass Spectrometry
- Chromatography Data Systems
