Chromatography integrated systems

When you start working across the Internet, the chromatography data system becomes an open system and the FDA rule requires controls. Using FDA s definition of electronic records, the laboratory chromatography data system generates electronic records. Based upon the definition, laboratories will need to consider more than just the raw data tiles. One must also include the method tiles, mn sequence tiles, and the integration parameters used for the data analysis. The need for a comprehensive audit trail is a critical component of the FDA regulations. The audit trail is an electronic record and is subject to the same controls. 

The equipment used in 2DLC is the same as in HPLC with the addition of valves and integrated control of both HPLC systems. Most chromatography data systems allow... 

Experimental Procedure. Figure 3 presents a schematic diagram of the apparatus. The chromatograph is a Varian Aerograph Series 1400 with a thermal conductivity detector and an associated Varian CDS 111 Chromatography Data System (integrator). We modified the chromatograph in two ways ... 

The system relies upon preliminary fractionation of the microbial crude extract by dualmode countercurrent chromatography coupled with photodiode array detection (PDA). The ultraviolet-visible (UV-Vis) spectra and liquid chromatography-mass spectrometry (LC-MS) of biologically active peaks are used for identification. Confirmation of compound identity is accomplished by nuclear magnetic resonance (NMR). Use of an integrated system countercurrent chromatography (CCC) separation, PDA detection, and LC-MS rapidly provided profiles and structural information extremely useful for metabolite identification (dereplication, Figure 14.1). 

ECONOMICS. Usually, the prime economic reason for buying an electronic integration system for a chromatography laboratory is to reduce operating costs. These reductions may be realized by both manpower or instrument savings immediately or over a long term. 

J Slobodnik, AC Hogenboom, AJH Louter, UAT Brinkman. Integrated system for online gas and liquid chromatography with a single mass-spectrometric detector for the automated analysis of environmental samples. J Chromatogr A 730 353-371, 1996. 

Integrator. Automatic digital integrator or chromatography data system compatible with the gas chromatograph. 

It is widely accepted that a validated system must uot receive data from au uuvalidated system through an interface. The approach to the validation of the interface to LIMS must take iuto accouut the need for the validation of all data sources (e.g., analytical equipment, Chromatography Data Systems, etc.) and the interfaces used to obtain these data. It should be the case that the validation of interfaces follows its own validation lifecycle with the importance of the integrity and security of data being of primary concern. 

There are many places dnring a validation project where it is appropriate to nse risk assessment as a basis for key decisions. This case stndy will follow a hypothetical implementation of an integrated chromatography data system (CDS) in a Quality Control laboratory (see Figure 29.1). In accordance with the documented user requirements, this system will ... 

Figure 29.2 shows how a high-level risk assessment may be documented (see Chapter 6 for Validation Determination Statement). The seven questions cover virtually every contingency that could necessitate validation. A yes answer to any of the questions indicates that the system requires validation. The integrated chromatography data system used as an example in this case study clearly meets a regulatory documentation expectation and impacts release decisions, and thus must be validated. 

Category Element of Example Integrated Chromatography Data System... 

Data acquisition was accomplished with the aid of a Varian Aerograph Chromatography Data System 220i. The UV detector was connected to the Varian system, which integrated the peak-height-retention-time data. The integral area vs. elution time distribution was converted to the desired differential distribution. 

CE and for developing methods based on chemical structures and retained chromatographic knowledge. Package is integrated with ACD/Spec Manager (MS, NMR, IR, UV-Vis) and with ACD database for log P, log D, and pKa. Able to import data from major chromatography data systems. HPLC system for automated method development ... 

Demands such as (i) improved analyte detectability and separation power (or sensitivity and selectivity) next to (ii) real-time confirmation of analyte identity and quantification, and (iii) the generally recognized need to increase sample throughput, have triggered the development of online (preferably automated) chromatography-based systems. The benefits of integrated analytical procedures, where the emphasis is on the inclusion of the sample preparation step, have frequently been discussed in the literature. ... 

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