Data integrity is achievable when the collection of data is complete, consistent and accurate (1). Failure to maintain data integrity compromises a company’s ability to demonstrate the safety and efficacy of its products. The recent escalation of serious regulatory actions related to data integrity violations has prompted the need to assess data integrity compliance, as well as, implement systems designed to guarantee it. Comprehensive measures must be taken to ensure data is attributable, legible, contemporaneous, original and accurate (ALCOA) (2). Preventative measures need to be implemented to assure that the validity, accessibility and integrity of data throughout its defined retention period is maintained. Automated system controls aimed at data integrity assurance include but are not limited to, written procedures, system validation, change control, system security (physical and logical), electronic signatures, audit trails, as well as, data archival, backup and retrieval. The incorporation of these basic automated measures into a quality system allows for enhanced confidence in the trustworthiness of data.
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