Combination of Old-Fashioned Values and ... - ACS Publications

Chapter 3

Downloaded by EAST CAROLINA UNIV on January 4, 2018 | http://pubs.acs.org Publication Date: August 1, 2002 | doi: 10.1021/bk-2002-0824.ch003

Combination of Old-Fashioned Values and Electronic Reporting Systems: Good Laboratory Practice Trial Reporting Marriage for the New Millennium W. H . Palmer A.C.D.S. Research Inc., 4729-A Preemption Road, Lyons, NY 14489

The infidelity of individuals and companies in the 70s submitting data to the Environmental Protection Agency (EPA) led to strict regulations by governmental agencies. In the 90s, the drug and pesticide industries demonstrated the increased efficiency and reduced paperwork achieved with electronic data reporting systems. Governmental agencies responded with more regulations. Electronic reporting systems are now commonplace in both the drug and pesticide industry. However, many electronic data devices are pushed to, and beyond, their environmental limits once these devices are taken out of a laboratory and into the field. In addition, a recent disaster within the industry has demonstrated the vulnerability of magnetic media in comparison to paper records. At the contract research company level, such loss of data or failure of electronic equipment under field conditions could be a catastrophe. A proposal that would match paper record security with the efficiency of electronic data reporting will be presented.

© 2002 American Chemical Society

Garner et al.; Capturing and Reporting Electronic Data ACS Symposium Series; American Chemical Society: Washington, DC, 2002.

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Act (FIFRA) Good Laboratory Practices (GLP) field trials has offered both advantages and disadvantages. This chapter will discuss the author's view on: 1) EPA regulations for electronic data reports and records will be equal to the current FDA regulations for the same; 2) Electronic records offer many advantages for governmental agencies, sponsors, and study directors; 3) Electronic records pose some problems for contract researchers and quality assurance people; and 4) A "marriage proposal" for combination of hard copies and electronic records.

EPA Present and Future Regulations While the Food and Drug Administration (FDA) has experienced some problems with public approval due to registered products that turned out to have serious safetyflaws,the public still is in favor of testing and marketing of new drugs that increase the quality of life. On the other hand, EPAfecesa public that mistrusts the pest control industry after the scandals of the 1970s. In addition, the public at large feels that pesticides and genetically modified organisms are unnecessary since we have such an abundance of food in this country. While some people think that EPA will "cut us some slack" for the use of computerized systems in field trials, the author disagrees that EPA will adopt a more lenient attitude. In addition, EPA has stated on several occasions that the agency wants to have consistent regulations, not only between divisions of EPA, but between EPA and other federal agencies. To facilitate this change, EPA has established some new offices and proposed rules including The Office of Environmental Information, the Central Data Exchange, and CROMERRR: Cross-media Electronic Reporting & Record-keeping Rule.

Electronic Record Advantages Governmental agencies, sponsors, and study directors will benefit from electronic records and reporting systems in the following ways: 1.) Such systems allow compliance with federally-mandated paper reduction standards; 2.) The systems allowfesterand easier exchange of information between the sponsors and EPA, between EPA and the public, and between EPA and the states; 3.) The systems will allow more accurate data exchange between these entities; and 4.) The systems will provide uniform types of reports and reporting requirements.


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Electronic Records: Potential Problems for Field Trials Computers for field trials have to pa-form in an environment that is much harsher than would be experienced in a laboratory situation. EPA's Good Automated Laboratory Practices (GALP) Section 8.7 states that the hardware of computerized systems have to be operated according to the manufacturer's specifications. The temperatures, humidities, static electricity, and dust presence in field trials often exceed the limits of the equipment's specifications. In the proposed combined Toxic Substances Control Act (TSCA) and EPA regulations, computer systems must be validated and there must be plans for security and disaster recovery. The GALP guidelines encourage a "stand-alone system behind locked doors", similar to FDA's "Closed System". FDA's regulations, Section 58.61 call for testing the computerized system in the "target environment". "Validation" has to be documented evidence that the system will perform consistent, quality records. Even international regulations of the Organization for Economic Co-operation and Development (OECD) defines "acceptance testing" (validation) as formal testing of a computerized system in its anticipated environment. This means that any laptop computer used in field trials would have to be tested under the extremes of temperature, humidity, etc., that might be encountered during a whole testing season. It might be possible to meet these requirements by keeping our computerized systems in a separate, locked, environmentally controlled room with computer access controlled by digital signatures for authorized persons. However, how do we get data collected in the field (calibration data and plot pass times) to the person entering the data into the computerized systems? Cell phones and two-way radios have been used with some success. In addition, a major fire at a contract facility indicated the vulnerability of magnetic media as opposed to paper records. Even though both types of records had been placed in high-qualityfireprooffiles,only the paper records survived in usable form. In some instances, the use of an electronic record rather than a paper record limits the ability of the researcher to use time-tested methods of sprayer calibration and other procedures where information is desired. Instead, a "universal" calibration method might be imposed by the trial software that is not the best, or is unfamiliar to the technical staff doing the procedure. The trial software also may not be compatible with facility records and so several pieces of facility data may have to be keyed into the program rather than allowing a simple "cut-n-paste" procedure.


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Electronic Records: Problems for Quality Assurance People An FDA document for its inspectors to use to detectfraudin paper records lists things such as erasure marks, pages that are unusually clean, papa* free from stains or smudges (paper should show evidence of normal wear and tear. These easily discerned instances are not available with the pristine electronic records. In addition, 21 CR Part 11 give a perception that Federal agencies may view paper records as being potentially more reliable than electronic records by stating that "paper records are a durable, unitized representation that is fixed in time and space"; paper records are harder to falsify than electronic records, methods to detect falsification of electronic records are yet to be developed, and "there is a perception [in the industry] that electronic records... are less significant., than paper records."

As A Contractor, Am I Opposed to Electronic Systems? We have invested over $30,000 to buy software and computerized systems to conduct trials at our three locations in the Northeast. That cost does not include the anticipated larger annual cost for validation, employee training on computerized systems, sofware/hardware upgrades, and more expensive archiving facilities. In our commercial tree-fruit enterprise, we use a sophisticated "smart" airblast sprayer equipped with ultrasonic sensors and computers that allow us to treat only where actual foliage is present. This equipment has allowed us to significantly reduce the amount of pesticides we use on our apples, pears, and stone fruit. Thus, we prefer to use technology rather than vice versa.

A "Marriage Proposal" of Electronic Records and Paper Records This proposal combines the electronic record advantages of less paper, fast and accurate reporting of field data, a database of information that can be accessed and sorted easily, and uniformity of information forms. For the field researcher, it provides the security of paper records of critical raw data. In any trial, the large majority of information is derived from a relatively small amount of raw data. These raw data, unlike information that can be obtained from alternate sources (i.e., weather data) are critical to reconstruct the trial at a later date. Such critical raw data to be entered on a small number of paper forms include such things as sprayer output, plot length, sprayer speed in the plots, who calibrated equipment and made the application, when they performed those functions, amount of test substance placed in what amount of



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carrier, etc. These data can be archived at the contract facility as part of the equipment log, transcribed to electronic forms, or sent to the sponsor for archiving. This system would allow the local researchers to use their familiar standard operating procedures for calibration, etc. If there is a time constraint caused by weather (trying to get applications on before the wind gets too high), then the information can be transcribed to the electronic forms, noted as a transcription, when time permits. This also allows a researcher to use people especially trained for each task, whether it is sprayer operation or data entry. The researcher can then e-mail up-dates of the trial as soon as the data are transcribed. This system avoids the high cost of validation of computerized systems, the use of e-signatures, or the unfortunate loss of critical raw data from a catastrophe such as a fire. At the end of the trial, another person (maybe from Quality Assurance) checks the electronic file against the raw data preserved by written records. If they are in agreement, then a statement is added to the electronic notebook as to the accuracy of the transcriptions. For quality assurance people, they will now have the critical raw data on paper so they can use all of the easy methods to check for potential fraud, inaccuracies, etc. In addition, they can now review the paper records at their convenience rather than having to tie up the researcher's computer to check records.

Conclusions The "marriage" of paper records with electronic records for field trials conducted under FIFRA regulations can be built on the advantages of each data media type. The long-term safety and immediate availability of critical raw data on paper records in ensured. The cost of validation of computerized systems and security is eliminated, thus reducing the cost of trials to the sponsor. Paper records can be used in harshest environmental conditions without compromising recovery of the data. Sponsors have the advantages of fast reporting of field data, easy search and recovery of data that is now in a database, fester report writing, and less archiving of paper records. The combination system would meet the needs of all the stakeholders in the agency/sponsor/contractfecility/qualityassurance organizations.


Combination of Old-Fashioned Values and ... - ACS Publications

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