Data integrity (DI) regulatory compliance experts are observing that industry in-house and third-party auditors are often not detecting failures because they are not viewing the systems and processes in the same manner as agency inspectors. Even in scenarios where firms have performed multiple audits in anticipation of pending inspections, regulators are identifying DI gaps that have not been recognized and/or risk-assessed appropriately. Along with adopting an investigator’s perspective in conducting internal audits, also being recommended is engaging third-party consultants with regulatory agency pedigrees that will apply the same rigor to audits as their former colleagues.
The perspective of regulators that the quality of the data and the quality, safety, and efficacy of the drug are directly interlinked will keep them focused not just on the final data, but on all of the systems, processes, and subcomponents that feed information into the final release decisions.
The compliance experts recognize that, despite thorough planning and best intentions, DI lapses will occur due to the complexity of the systems involved and the variability created by human interactions with them. Identification of a true root cause, in turn, is challenging because failures often appear in isolation and may need to be fitted into larger patterns. Earlier detection, they note, can lead to earlier remediation and therefore reduce risks to patients and lower potential liabilities for manufacturers. When these failures are discovered through regulatory inspections or declared by whistleblowers, the cost in terms of remediation and business reputation proves significantly higher.
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