Steps to Data Integrity Compliance

ProPharma Group says pharmaceutical companies should always be ready for planned and unplanned internal and external inspections. In an online post, “Although there are various types of audits and inspections,” the post says, “and in the current landscape there has been a shift to virtual audits, there is a trend that shows regulators are focusing increasingly on overall data governance and end-to-end data integrity. An effective implementation of compliance and data integrity aspects within your organization will assure that you pass each inspection without any hassle.”

The post discusses what the consultants call the ALCOA+ principles — Attributable, Legible, Contemporaneous, and Original, with the “+” covering Complete, Consistent, Enduring, and Available.

The five steps it lists for good practices compliance are (1) create awareness; (2) classify data; (3) keep track of data flows; (4) implement access controls, and (5) prepare for inspections.