Data Integrity and Audit Trail Review

Within the industry of pharmceuticals and medical devices, data´s integrity - especially in the context of computerized systems - is required and regulated via predicate rules, laws and directives such as 21 CFR Part 11 or EU Annex 11, and further national legislation. In recent times, the regulatory inspectors´ focus during audits has moved this area to become a dedicated focal point when it comes to compliance considerations. One important and powerful means to facilitate demonstration of a system´s data integrity is the review of audit trail data. Nonetheless, the question remains how to best leverage on that data and what to look for.

This presentation will shed light on the aforementioned scope and background in the context of computerized systems used within the regulatory affairs area, such as RIM systems. Based on to be assumed data elements under governance – and embedded in an assumed business process – ideas will be presented how a sample audit trail review process could be conducted and what check points could be included into a potential review list. Within this process, practical examples as experienced in real life will be shared as potential building blocks with the intention to facilitate the listeners thought processes when tailoring own audit trail review practices.

Additional Info

  • Date(s): 30–Nov–2018
  • Event/Context: DIA eDM 2018: Clinical and Regulatory Operational Excellence Forum
  • Location(s): Barcelona, Spain
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