Most laboratories have an ethics policy or employee handbook covering data integrity, yet, the headlines are still regularly filled with reports of a laboratory staff member committing
fraud and subsequently doing time! It’s hard to imagine that data integrity would be an issue in metrology and testing, yet even the new ISO/IEC 17025 standard addresses impartiality and confidentiality issues. The U.S. Food and Drug Administration has implemented guidance on data integrity: “FDA expects that data be reliable and accurate. Applicable regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models.” What do we mean by data integrity? FDA notes “For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.” One interesting note in FDA guidance documents is that during an audit, there is no differentiation between sloppiness and intentional fraud! In the NIST Office of Weights and Measures seminars we teach classroom/laboratory “ground rules” that are very similar to the FDA guidance documents. We consider these ground rules and guidance documents to be good laboratory practices. But are they? Let’s find out!