Data Integrity Assessment Services

A data integrity assessment is a structured review of how data is created, recorded, stored, changed, reviewed, and retained across your systems and processes. It examines whether records meet expectations for traceability, accuracy, completeness, and control under standards such as ALCOA+, 21 CFR Part 11, ISO-based quality systems, and other applicable regulatory requirements. The goal is to identify gaps, rank risks, and define corrective actions.

The four commonly referenced types of data integrity are entity integrity, referential integrity, domain integrity, and user-defined integrity. In regulated environments, organizations also evaluate practical integrity attributes such as attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available data. A strong assessment considers both database structure and real-world compliance controls, including audit trails, access management, review practices, and documentation discipline.

Regulated companies need a data integrity assessment to reduce compliance risk before inspections, submissions, customer audits, or system changes expose weaknesses. Poor controls around records, audit trails, user access, or documentation can lead to observations, delayed approvals, warning letters, or unreliable decision-making. An assessment helps organizations detect vulnerabilities early, strengthen governance, and demonstrate that critical data can be trusted throughout its lifecycle.

A data integrity assessment often reviews requirements and expectations tied to ALCOA+, FDA 21 CFR Part 11, 21 CFR Part 820, ISO 13485, ISO 15189, ISO 17025, GLP, GCP, HIPAA, and related internal procedures. The exact framework depends on your industry, systems, and market obligations. Assessors typically examine electronic records, audit trails, validation evidence, SOPs, training records, change control, and data review workflows.

Elexes evaluates the full data lifecycle, including data entry, review, approval, storage, backup, retrieval, change history, and retention controls. We also review system configuration, user roles, audit trails, validation documentation, SOP alignment, training effectiveness, and cross-functional governance. Where relevant, we assess LIMS, ELN, spreadsheets, hybrid paper-digital workflows, and supporting quality records to identify both technical and procedural weaknesses.

The timeline depends on the number of systems, sites, departments, and records involved, but many assessments begin with a focused scoping phase followed by document review, interviews, testing, and reporting. A targeted review may take days, while broader multi-system assessments can take several weeks. The final output typically includes documented findings, severity ranking, regulatory references, and a prioritized remediation plan for implementation.

Yes. Elexes can support remediation after the assessment by helping update procedures, strengthen documentation controls, improve traceability, prepare validation evidence, train staff, and align systems with regulatory expectations. We also provide internal audits, digital transformation support, RAQA operational assistance, and targeted remediation services. This allows organizations to move from gap identification to practical closure with continuity and accountability.

These services are especially valuable for medical device companies, biotech firms, diagnostic companies, clinical laboratories, analytical testing facilities, pharmaceutical testing labs, digital health teams, and research organizations operating in regulated environments. They are particularly useful before inspections, accreditation reviews, submissions, software migrations, or quality system upgrades. Any organization relying on defensible records and controlled data can benefit from an independent assessment.