August 18th, 2017
This is a newly formed Standards Committee Writing Group will draft a TR, Data Integrity: Guidelines for collecting, recording and retaining data within the scope of quality management systems. The purpose of this proposed document is to provide guidance for collecting and using data, in both paper and electronic format, to ensure data are complete, consistent and accurate. The document would supplement quality management systems by providing additional guidance around requirements for documented information (both paper and electronic). A fundamental principle of a quality management system is “Evidence-based decision making.” The principle is followed by the statement “Decision bases on the analysis and evaluation of data and information are more likely to produce desired results.” This principle is dependent on the integrity of data.
The document would be aligned with guidance already existing in the regulated life science industry (pharmaceuticals and medical devices), which require data are attributable, legible (and traceable), contemporaneous, original, and accurate (ALCOA).
Please consider becoming involved with the Writing Group to draft the document, or as a reviewer to review document drafts. The time commitment is approximately two years. For the Writing Group, we anticipate that there will be 2 or 3 meetings a year (remote and face to face).
Help us to provide solutions to ever increasing data integrity failures. Please contact ASQ Standards at with your interest in being part of the Writing Group or as a reviewer. Please include a biography, no longer than 250 words, on why you will be able to contribute to the development of the data integrity guidance.
Please respond ASAP but no later than September 1, 2017.
Thank you for your consideration,
John Mascaro, ASQ Audit Division representative
JP Russell, ASQ Standards Committee sponsor
Kim Strok, Subject Matter Expert
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