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Data Management: Ensuring Our Data Is Ethical and Legally Defensible
Oral Presentation
Prepared by J. Boyd
Southwest Research Institute, 6220 Culebra, San Antonio, Texas, 78016
Contact Information: jboyd@swri.org; 210-522-2169
ABSTRACT
Are we ensuring that each set of data produced are competent to meet the legal defensibility of potential litigation? What is wrong with the data? Measures must be taken to ensure that data meets compliance for any regulatory agency or consumer. Data submitted for litigation is not always reviewed by someone who is knowledgeable in that area. The areas of concern are; do we do and report what we say we do. Are we meeting the regulations, statements of work, internal procedures, and quality control measures for the process? Are we meeting the review requirements to verify and validate the work performed? This presentation will provide examples of repeated problems in the industry and how to document properly to ensure that data will meet litigation requirements.
Data integrity and defensibility are critical factors for regulatory work. Most analytical or testing data for government or commercial aspects is subject to litigation. The highest quality data establish documents that provide repeatability of the work and legally defensible data. Litigation looks for questionable data, loopholes that prompt questions to the data, and missing information that was critical to the completion of the data report or package. In making decisions regarding integrity of the testing and results to be reported, ethical dilemmas can be critical judgments in business today.
Oral Presentation
Prepared by J. Boyd
Southwest Research Institute, 6220 Culebra, San Antonio, Texas, 78016
Contact Information: jboyd@swri.org; 210-522-2169
ABSTRACT
Are we ensuring that each set of data produced are competent to meet the legal defensibility of potential litigation? What is wrong with the data? Measures must be taken to ensure that data meets compliance for any regulatory agency or consumer. Data submitted for litigation is not always reviewed by someone who is knowledgeable in that area. The areas of concern are; do we do and report what we say we do. Are we meeting the regulations, statements of work, internal procedures, and quality control measures for the process? Are we meeting the review requirements to verify and validate the work performed? This presentation will provide examples of repeated problems in the industry and how to document properly to ensure that data will meet litigation requirements.
Data integrity and defensibility are critical factors for regulatory work. Most analytical or testing data for government or commercial aspects is subject to litigation. The highest quality data establish documents that provide repeatability of the work and legally defensible data. Litigation looks for questionable data, loopholes that prompt questions to the data, and missing information that was critical to the completion of the data report or package. In making decisions regarding integrity of the testing and results to be reported, ethical dilemmas can be critical judgments in business today.