Data Integrity in the Medical Device Industry

By Tom Middleton, Sparta Solutions Architect | March 2, 2017

Excerpt from Medical Product Outsourcing:

Improving patient safety is at the heart of the medical device industry, but many manufacturers may not realize that this starts with data integrity in the manufacturing process. The integrity of data generated by medical device manufacturers is extremely important, because properly recorded information is the basis for manufacturers to ensure product identity, strength, purity, and safety. The FDA defines data integrity as “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.” Put simply, data integrity builds the necessary foundation upon which to create safe medical devices.

While most medical device manufacturers use electronic systems, there are still some companies that use paper systems or manual excel spreadsheets. Paper and manual systems have no controls, so there is an increased risk of data integrity issues. For example, it is significantly easier to manually change and reprint new versions of a document with different data when using a non-electronic system. While it is rare that a company or individual would act maliciously, it unfortunately does happen. Utilizing an electronic system where this information is locked down, automatically time stamped, and can’t be maliciously altered allows for greater confidence in the data. Manufacturers need to be assured that regardless of where information is stored, the system’s data is never invalid, falsified, or adulterated.

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