Data Integrity Assessment & Remediation

Data integrity has become the dominant theme in regulatory findings worldwide, and a single citation can jeopardize an entire site's credibility — and its products. PharmExpert assesses your records, computerized systems and data governance against ALCOA+ and current FDA, MHRA, WHO and PIC/S guidance, then remediates the gaps across people, process and systems to a verifiable standard.

Our assessment follows the data across its full life cycle — generation, processing, review, reporting, retention and disposal — in both paper and electronic systems. We examine audit-trail configuration and, just as importantly, whether audit trails are actually reviewed; access controls, user privileges and segregation of duties; the handling of original records and metadata; and the laboratory systems (chromatography, LIMS) that attract the most scrutiny.

Technology alone never explains a data-integrity problem. We assess the behavioral and cultural signals that distinguish a healthy environment from a vulnerable one — how staff talk about re-testing, whether review is a genuine check or a signature, and whether leadership creates pressure that quietly rewards shortcuts. Sustainable data integrity is as much about culture as configuration.

The output is a prioritized, risk-ranked remediation roadmap and the controls to execute it: technical fixes to systems and access, procedural changes to review and governance, and training that changes behavior. We can deliver the assessment alone, or carry the remediation through to demonstrable closure — exactly what an inspector returning to the site will expect to see.