Compliance & Standards
Digital Systems & Data Integrity
Part 11, Annex 11, CSV/CSA, ALCOA+, and governed digital quality systems.
Regulatory landscape
Standards and frameworks in this category
Each topic links to an existing Viltis service page describing implementation, assessment, and remediation support.
21 CFR Part 11 & Annex 11
Electronic records, signatures, and EU Annex 11 alignment.
Computer System Validation (CSV)
Risk-based validation for GxP computerized systems.
Computer Software Assurance (CSA)
Risk-based assurance approaches for production and quality software.
Data Integrity & ALCOA+
Assessments and remediation for integrity of regulated data.
QA for Digital Systems
Quality oversight for digital health and emerging technologies.
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Discuss digital systems & data integrity compliance
Share your current controls, upcoming audits, or remediation priorities.