Data integrity is the FDA's
number one enforcement priority.
Most data integrity findings trace back to the same root cause: no systematic program. Not bad intent — missing infrastructure. Compliance Group builds the data integrity programs, procedures, and governance frameworks that keep you out of Warning Letters.
Data integrity leads all FDA Form 483 observation categories. The organizations that receive Warning Letters aren't necessarily cutting corners — they're operating without the systematic controls that make ALCOA+ compliance demonstrable at scale. A data integrity program is procedural, cultural, and technical. All three have to work together.
The data integrity gaps that become audit findings.
No systematic ALCOA+ program
Most organizations have data integrity procedures but no systematic program: no risk assessment driving which systems get which controls, no periodic review cadence, no defined escalation path when something surfaces.
Multi-system environments have no unified view
Veeva Vault, LIMS, MES, and eTMF reviewed separately — each team managing its own audit trail, with no cross-system pattern analysis and no centralized accountability for the data integrity posture.
User training and authorization governance is informal
Audit trails show actions. They don't automatically verify that the user had current training and appropriate authorization at the time. Most organizations can't demonstrate this systematically under audit.
Remediation programs fail without root cause resolution
Responding to a data integrity finding by updating procedures misses the structural root cause. Without systematic remediation that addresses the underlying controls failure, the finding recurs.
AI-enabled workflows create new data integrity obligations
When AI tools make recommendations acted upon in validated workflows, the audit trail for those decisions is a new category of data integrity requirement that most programs haven't addressed.
Periodic reviews are reactive, not continuous
Quarterly or annual data integrity reviews create windows between reviews where events can occur, compound, and become significant findings before anyone notices. The gap is structural.
Data integrity programs built to withstand inspection — not just satisfy it.
Compliance Group's data integrity practice combines deep regulatory expertise with practical program design. We build the controls, procedures, and governance infrastructure that makes ALCOA+ compliance demonstrable — not just documented.
Data Integrity Program Assessment and Design
Systematic assessment of your current data integrity posture: risk-ranked system inventory, control gap analysis against ALCOA+ requirements, and a prioritized remediation roadmap. We design the program architecture — SOPs, governance structure, escalation protocols — that makes compliance systematic rather than individual-dependent.
Data Integrity Remediation and CAPA
For organizations responding to FDA findings or internal audit observations: root cause analysis, CAPA development, and remediation execution that addresses the structural failure — not just the surface symptom. We write the CAPA narrative, implement the controls, and prepare the evidence package for regulatory response.
ALCOA+ Controls Implementation
Systematic implementation of ALCOA+ controls across your validated system estate. Includes system-specific control specifications, procedure development, user training design, and periodic review frameworks that demonstrate continuing compliance under multi-system environments.
Data Integrity Program Governance
Ongoing management of your data integrity program: periodic review scheduling, emerging issue triage, procedure maintenance, and regulatory intelligence — so your program evolves as FDA expectations evolve. Available as a managed service embedded within a broader compliance program.
CLAiRE Audit Trail Review: continuous data integrity assurance on top of your existing systems.
Once your data integrity program has the right procedures, governance, and controls, CLAiRE ATR replaces the 5%-quarterly-sample model with 100% daily coverage — eliminating the 90-day blind window entirely.
CLAiRE AI Agentic Platform's Audit Trail Review capability runs on top of your existing Veeva Vault, LIMS, MES, eTMF, and other GxP systems. Not a replacement for your data integrity program — the continuous monitoring layer that makes it defensible at scale.
- 100% audit trail coverage — every record analyzed daily, not 5% quarterly
- Cross-system intelligence — unified analysis across Veeva, LIMS, MES, and eTMF simultaneously
- User training and authorization cross-check — automated for every action in real time
- ALCOA+ compliance monitoring — systematic, not reviewer-dependent
- Regulator-ready findings reports — formatted for direct inspection use
- Microsoft Teams alerting — real-time notification when findings surface
Data integrity program governance is the foundation. CLAiRE AI Agentic Platform ATR capability provides continuous monitoring across your validated stack. iQuality QX creates direct CAPA initiation from ATR findings — closed-loop data integrity from detection to resolution.
Book a Free Assessment.
45 minutes with a senior expert—not a sales rep. We assess your current data integrity posture, identify your highest-risk gaps, and give you a written brief. No commitment.
Book Your Free Assessment