Automated data recording

Constant strain for stress relaxation tests and constant load creep tests may be conducted in simple devices. Temperature control is critical since the results are usually applied as a spectral representation for structural analysis or research purposes. Figure 8 illustrates a multistation creep tester with automated data recorders. Strain and load endurance tests are conducted in similar devices, but the conditions existing at failure and time to failure are normally the only data required. The endurance tests are used frequently to supplement the constant displacement rate tests for routine evaluation. 

It is the essence of transient measurements that a certain perturbation is applied to the electrode and then the response is recorded as a function of time. Usually, the transition times are short (fractions of a second), and the transient measurements are performed very rapidly with automated data acquisition. 

The OPMBS used a custom-written spreadsheet application, i.e., a workbook, in conjunction with laboratory automation systems to standardize data recording, calculations, and presentation of results. Devising this approach required careful differentiation between (a) the workbook used to calculate and report the results and (b) the data acquisition systems used in each laboratory. The laboratory systems were used to collect the raw chromatographic data, but the calculation modules in the laboratory systems were not used. Instead, all calculations were done in the workbook. Use of the laboratory systems to collate and output the final results was considered but was rejected for two reasons. First, different laboratories used different systems, and some laboratories used more than one system. The output characteristics of the various systems differed considerably and would have required extensive modification... 

Audits of each phase of the study should include personnel training, preparation of collection forms, application calibration, each sample collection procedure, sample transport, each type of chemical analysis, data recording, data entry, data verification and data storage. Data collection in the field is often tedious if automated logging devices are not in place. To ensure data integrity, the paper and ink used for field studies should be waterproof. Each data collection form should contain appropriate locations for information detailing the time and location of sample collection, sample transport and sample analysis. Data collection forms should be stored in an orderly fashion in a secure location immediately upon return of field teams from the field at the end of each day. It is also important for data quality for studies to collect necessary field data seven days per week when required. In our experience, poor study quality is likely when field sample and data collection do not proceed on weekends. 

Automatic analysis consists essentially of the same steps as the corresponding manual method (p. 4). In some cases this may be simple, the requirements amounting to a mechanical device for presenting the sample to the detector, a timer to control the time of measurement and a data recorder. However, if sample pretreatment and separations are necessary a variety of wet chemical stages needs to be automated. Such automated steps may be included in what remains essentially as an operator procedure. For... 

There are typically six components in an HPLC system (1) solvent reservoirs (2) a pumping or solvent management system (3) an injector, which can be either manual or automated (4) a column (5) a detector (6) a data recorder, which can be an integrator or a computer system. 

A Waters Model 150C ALC/GPC was interfaced to a minicomputer system by means of a microcomputer for automated data collection and analysis. Programs were developed for conventional molecular weight distribution analysis of the data and for liquid chromatographic quantitative composition analysis of oligomeric materials. Capability has been provided to utilize non-standard detectors such as a continuous viscometer detector and spectroscopic detectors for compositional analysis. The automation of the instrument has resulted in greater manpower efficiency and improved record keeping. 

Benefits have been realized from the automation of the Waters Model 150C ALC/GPC in several areas. First, a significant amount of time has been saved by performing automated data collection with automatic injection during night operation while unattended. Secondly, record keeping is more complete and accurate. This has... 

All raw data, documentation, and records generated in the design and operation of the automated data collection system must be archived in a manner that is orderly and fa-cihtates retrieval. If stored on the system, such data must be... 

Automated component addition verification Data record availability, retention, storage medium, and reviews... 

This section concentrates on the Tice data used for automation and process control, which requires two more conditions a high frequency of pressure data recorded after the valve is closed, e.g. 50-100 data per second (see Figurel.78.1 and related text)... 

FD-483 Observation. The firm failed to maintain complete records of all stability testing performed in accordance with 21CFR211.166 as required by 21CFR211.194(e). For example, there was no assay data recorded in the analyst s notebook or automated stability database for the 18 and 24-month stability test points. ... 

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. 

Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system as required by 21 CFR 820.70(i). For example your hrm s XXXX is computer controlled. It uses software programs to record data from measurements of the radius of curvature and comeal refraction of the eye. However, your firm has not validated the software and computer system used to record this data for its intended uses. Your firm has no documentation to assure that they perform as intended. Also, there is no validation and documentation of subsequent changes to the software. 

Time This is probably the parameter that is measured most accurately through the use of automated data collection equipment. The most significant errors arise in identifying the time when reactant reaches reaction temperature during rising temperature experiments, there may be a time delay between the value recorded and the value representative of the sample. 

The reactor system is automated with a computer HP 9816 and a data acquisition and control unit HP 3497A of Hewlett Packard. The programme a.o. checks if all variables are within preset safety limits. In case of emergency the programme switches the gas feed from H2 to N2 and stops the liquid feed. The key variables are the temperatures in the catalyst bed, the gas and the liquid inlet temperatures as well as the gas and the liquid outlet temperatures and fiirther the reactor pressure, the inlet and the outlet gas flow rates and the liquid feed flow rate. They are temporarily stored in the computer memory and later transferred on floppy disk. The temperatures at all other locations are monitored and recorded with a Philips PM 8237A multipoint data recorder. 

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