Electronic records components

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. 

An electronic record must consist of two components a human-readable section and a machine-readable (computer) section. The content of the human-readable section will include information about the creation and any additional processing of the data. 

In addition to testing the system components, a test of software functionality would be performed to test the system software operation and electronic records and electronic signatures (ERES) compliance (security, data integrity, data backup, and archive). In order to test the software functionality, a predetermined set of instructions can be entered step by step into the system. The system responses are then compared to the expected outcomes of the instruction and any problems with the execution are determined. Some vendors will provide a standard set of data which can be processed by the system to verify the data-handling capability of the system. 

The second fundamental element in Part 11 is the high level of security required to protect regulated electronic records. The requirements for application and network component security can be found in Table 15-1. The controls that are implemented resulting from the security related requirements are intended to build a trusted digital environment. The attributes relevant to a trusted digital environment are ... 

All GxP functions, processes, components, and devices identified within the GxP assessment should be challenged as part of the Design Review. Consideration may also be given to occupational health matters such as the potential effects of the computer system and associated equipment on the personnel who may use or contact the system. GxP functionality includes the use of electronic records and signatures. Hybrid systems must be dehned and subject to a verification process to determine whether or not they are robust. It is often nsefnl for processes to be mapped, showing critical points in the process and how varions compnter systems support these critical process points. 

Electronic records are created when their component raw data is processed and stored to a durable media. From this point on, electronic records require audit trails and metadata to be maintained as discussed later. Examples of electronic raw data used to compile electronic records include calculations used to determine a sample potency range, individual temperamre readings from an autoclave used to plot a temperature profile, individual points used to plot a peak in a... 

All LIMS functions (e.g., manual data entry, automated data entry, and report generation) should be assessed to evaluate the effect that they could have on the data that will support regulatory submissions and release of product to market. This approach must be methodical to ensure that relevant functionality is not overlooked. It is essential, for instance, that Business Continuity Plans are verified as being appropriate and workable. This testing should cover all aspects of the recovery process from the loss of individual components (e.g., an analytical instrument interface) to the full loss of LIMS (e.g., representing a catastrophic failure of the LIMS server). The criticality of the data associated with the management of Electronic Records and Electronic Signatures should also be a focal point. However, it must be accepted that these assessments can be subjective and therefore they rely heavily on the experience of the assessors. 

Security and access privileges must cover all component systems making up the integrated solution. Issues here include passwords tmique to the individual, that must not be shared among user classes. Electronic records passed between systems must be accompanied by their audit trail requirements. A centralized database may ease management of electronic records. The use of Web... 

The business owner of a particular system is ultimately accountable for the electronic retention of business data. Support groups are often delegated responsibility for the electronic record retention of technical data such as operating systems, source code, configuration records, and any other software necessary to operate the application itself, including supporting documentation for these components. 

An electronic record represents a record in digital format. Even though the components and requirements of an electronic record are defined by its application, a system for creating and maintaining electronic records has basically the following components ... 

Usefulness of GC as a separatory technique cannot be over-emphasized in view of its several other advantages, besides the one already referred to above, namely the rapidity with which it brings about separations. The amount of sample used needs to be indeed small. With the elution technique used in gas chromatography, the column is ready for the next sample as soon as the previous one has passed through. Columns ordinarily have long life and it is not uncommon to have a column perform satisfactorily for a year or two. The usual apparatus employed is essentially simple and inexpensive but for the electronic recorder needed for the automatic recording of the chromatograms which certainly is an expensive component. 

First, many mixtures can be separated by this technique when no other method is adequate. Second, as little as 1-10 /xL (1 /xL=10" L) of a mixture can be separated by this technique. This advantage is particularly important when working at the microscale level. Third, when gas chromatography is coupled with an electronic recording device (see following discussion), the amount of each component present in the separated mixture can be estimated quantitatively. 

The magnetic properties of maghemite have made it an important component of magnetic inks employed in photocopiers, laser printers, etc., and as the chief magnetic compound in electronic recording media (see review by Buxbaum, 1998). The name maghemite is a contraction of magnetite and hematite. 

Reliability Analysis Center Handbooks Government and Military Data summaries of hundreds of records by component and environment Electronic component reliability data. i.e. microelectronic devices. high technology components 110. 

Miniaturisation of electronic components has enabled the construction of a compact, portable, battery-operated recording voltmeter. The principal use of this instrument is to measure pipe/soil potential fluctuations over a period of time. The instrument can be modihed to measure current variations. 

The detector. The function of the detector, which is situated at the exit of the separation column, is to sense and measure the small amounts of the separated components present in the carrier gas stream leaving the column. The output from the detector is fed to a recorder which produces a pen-trace called a chromatogram (Fig. 9.1fr). The choice of detector will depend on factors such as the concentration level to be measured and the nature of the separated components. The detectors most widely used in gas chromatography are the thermal conductivity, flame-ionisation and electron-capture detectors, and a brief description of these will be given. For more detailed descriptions of these and other detectors more specialised texts should be consulted.67 69... 

The basic components include a Nd YAG pulsed laser system which is coaxial with a He Ne pilot laser and visible light optical system. The latter system enables the analytical area of interest to be located. The TOF-MS has a flight path of 2m in length, with an ion detection system that includes an electron multiplier detector, a multichannel transient recorder, together with a computer acquisition and data processing system. 

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