Data Integrity

Data Integrity

Build Trust into Every Record

In an industry where every batch, test, and result matters, data integrity is non-negotiable. Agon’s Data Integrity services help pharmaceutical manufacturers build resilient systems that ensure every record is attributable, legible, contemporaneous, original, and accurate—aligned with ALCOA+ principles. Whether you operate on paper, electronic, or hybrid systems, we audit,
design, and validate controls that make your data audit-proof and decision-ready.

What We Deliver

ALCOA+ Implementation Framework

Diagnostic assessment of current data lifecycle practices
Mapping of workflows across QC, production, QA, warehouse, and digital platforms
SOPs and governance models that operationalize ALCOA+

Electronic & Hybrid Systems Compliance

21 CFR Part 11 and EU Annex 11 readiness assessments
User access controls, audit trail reviews, electronic signature configuration
Support for LIMS, ERP, SCADA, and CSV-aligned platforms

Data Flow & Risk Mapping

Identification of vulnerable data touchpoints and integrity threat
Remediation plans for gaps in documentation, traceability, and backups
Cross-functional training for lab analysts, production teams, and reviewers

Why It Matters

Regulatory bodies prioritize data integrity in every inspection
Protects your product release decisions from legal and safety risks
Ensures patient safety by securing traceability and reproducibility
Drives confidence in every analytical result, batch record, and audit trail
Prevents data manipulation, loss, or unverifiable actions

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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