Data Integrity & ALCOA+ Compliance

Data integrity and ALCOA+ compliance mean regulated records remain attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available across their lifecycle. FDA inspections frequently cite data integrity issues in laboratories, manufacturing, and clinical systems even when other GxP controls look adequate on paper. Viltis helps organizations assess data flows, access controls, and procedural gaps that put electronic and paper records at risk of observation.

Strong data integrity programs examine how data are created, modified, reviewed, transferred, and archived. Shared passwords, disabled audit trails, uncontrolled spreadsheets, and undocumented reprocessing are still common sources of findings. Mapping systems and hybrid paper-electronic workflows reveals where ALCOA+ principles break down in practice. Our consultants pair technical control reviews with SOP and training assessments so fixes address both systems and day-to-day behavior on the bench or line.

Remediation should be risk-based and evidence-driven. Not every spreadsheet needs the same controls as a validated LIMS, but every GxP decision record needs a clear ownership path and retention plan. We help teams prioritize high-impact gaps, document interim controls, and align CAPA work with inspection timelines. Training is included so analysts and operators understand why contemporaneous recording and second-person review matter, not only how to click through a procedure checklist.

Viltis provides data integrity consulting and specialist support for laboratory, manufacturing, and clinical records. We do not issue certificates or certify that a site is ALCOA+ compliant; that determination remains with your quality unit and regulators after inspection or audit. Deliverables typically include risk assessments, gap reports, control recommendations, and inspection-facing narratives that match your QMS language, SOP set, and CAPA process.

Data integrity and ALCOA+ activities often include

• Data flow mapping across clinical, lab, and manufacturing systems
• ALCOA+ risk assessments and control gap analysis
• Audit trail, access, and privilege reviews
• SOP and documentation alignment for hybrid workflows
• CAPA support for data integrity observations
• Inspection readiness focused on data integrity themes

If an audit or FDA interaction raised data integrity questions, or you are modernizing systems and want controls designed in from the start, we can help build a practical remediation plan. Reach out to Viltis to scope the highest-risk data paths, systems, and paper records first.