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During a validation exercise, test results should be initialed and dated by the person executing the test.

Note: It is important to ensure a signature log is maintained to identify the signatures, initials and/or aliases of people completing paper records. This can be recorded manually by initialling and dating a paper record or by audit trail in an electronic system. This should include who performed an action and when. AttributableĪll data generated or collected must be attributable to the person generating the data. Data integrity and access control issues featured heavily within the warning letters issued by the FDA in 2015 so here is a timely refresh on the fundamentals. These simple principles should be part of your data life cycle, GDP and data integrity initiatives.

ALCOA relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate. The acronym ALCOA has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP).

Medicinal Cannabis Facility Design Expand.