Automated data entry

Special rules apply in the case of automated data collection systems the person responsible for data collection must be identified at the time of data input. Changes in automated data entries must be made in such a way that the original entry is saved, and the person responsible for making the Copyright 2003 Marcel Dekker, Inc. 

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. 

FDA regulation 21 CFR Part 58.130(e) states ... Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified. ... 

All computers may also employ office software, such as spreadsheets and word processing programs. These programs can operate with manual or automated data entry with on-line connection to the analytical data acquisition and evaluation system. 

The general approach to a risk assessment is to identify all of the functions that are performed by the LIMS hardware and software (e.g., manual data entry, automated data entry, report generation) and to assess each of the functions against the effect that they could have on the data that will support regulatory submissions. This approach must be methodical to ensure that... 

Figure 3. Data flow in automated data entry system...

Web-based data collection and management systems provide a mechanism for remote data entry, where entered data are added to a centralized database once the submit button is pressed. They can be designed to automate the various aspects of clinical trials such as eligibility evaluation, data collection, and tracking specimens. They also serve as a resource site for participating sites to access trial-specific information, facilitate communication, track data queries and their resolutions, and allow administrative management of trials [28, 29]. For these reasons, they play an important role in facilitating the conduct of international clinical trials. 

Most e-Clinical software consists of integrated suites of applications that support the clinical research process, including various ways of data entry that include in-house data entry, remote data capture, batch data load, and scan forms. These suites enable customers to quickly and easily design studies, capture clinical data, and automate workflow. Some e-clinical software systems are also Internet based. 

Errors and Inconsistencies in Adverse Event Coding. Adverse events are also subject to errors and inconsistencies by coders and data entry personnel. Many of these inconsistencies become very important when adverse events are analyzed by automated software. 

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. 

SGX-CAT maintains a direct T1 network connection from the Advanced Photon Source in Illinois to SGX San Diego. Database inquiries are handled over this link. Interactions with the database occur in three ways. An extensive web-based system is used for data entry and retrieval. For crystals generated by external users of the beamline, upload of an electronic spreadsheet transfers the required crystal data attributes to the SGX LIMS. For automated operations, such as crystal screening and data collection, custom scripts place the computed results directly into the database. 

Written procedures and practices must be in place within the laboratory to verify the accuracy of manually entered and electronically transferred data collected on automated systems. The primary documentation for data entry requirements is an audit trail. Laboratories must ensure that an audit trail exists and is maintained. This audit trail must indicate date and time stamps for each record transmitted and the source instrument for each entry. 

Buelke-Sam, Collaborative Behavioral Teratology Study Programmed data entry and automated test systems, Neurobehav. Toxicol. Teratol., 7(6)... 

Extraction scientist who is responsible for sample preparation should be certified prior to extracting real study samples. The validated extraction method has to be followed exactly. The raw data entries have to be documented promptly such as lot numbers of STD and QC, IS, extraction reagents, matrix, the IDs of automation tool and pipette, the time for study sample removal and return to storage and the completion of extraction. Instrument operator who is responsible for analysis has to perform SST test and assess sensitivity and carryover prior to initialing batch. Instrument operator has to... 

Enhancing automated error checking processes for critical database entries, such as by requiring a data entry confirmation or building acceptance criteria logic into critical fields... 

Less automated systems that need manual input to confirm that an activity has been completed require data entry to be contemporaneous. If this were not the case, an inspector might walk, for instance, round an available stock area of the warehouse, notice an unattended pallet on a floor in the picking area which is available for picking, and ask someone to show him where this pallet should be. If an enquiry is made into the system that shows that the pallet should be in a separate quarantined area, as outlined in a current SOP, then staff should expect to discuss this further with the inspector. 

Each form should be entered into a computerized database linking forms with voucher numbers. The data entry program can mimic the exart format of the form, with drop-down menus for multiple-choice responses, and it can perform consistency checks as the date is entered. The data entry phase can provide an additional opportunity to detect transfer of vouchers to indirect beneficiaries. Comparing names and surnames with those recorded at the time of distribution can be a first screen, but variations in spelling and the inclusion or exclusion of middle names can make it difficult to automate this process. If information such as the recipient s date of birth was recorded when the vouchers were distributed, it may be a better first screen for voucher transfer. 

Sample analysis requires that sufficient test data have been obtained for a sample, such that all internal and external requirements are met. It also covers the accuracy and applicability of test data. Related specific functions include manual and automated result entry, validating against method specification, checking of detection limits, and instrument management. 

Error Reduction Without automation, data needs to be entered and reentered at several stages in the process. This inevitably introduces clerical error. With electronic data exchange, the data is only entered once and reused in all subsequent steps. Thus, human error in data entry can be significantly reduced. 

Automated design was the concept that a computer could be fed the initial conditions or inputs of a process and could iteratively calculate the optimal combinations of materials, energy, and unit operations and processes. If fully realized (and it has not been), then the chemical engineer would become merely a data entry operator. 

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