EP2AS VAL
Rule-Based Automatic
Validation and Correction
for eCTD Leaf Files
Purpose-built for regulatory submissions, eP2AS VAL applies rule-based automatic validation and correction to PDFs converted from Word documents — checking page requirements, internal bookmarks and links, cross-file consistency, fonts, and image resolution. It also supports GxP compliance, computerized system validation (CSV), and 21 CFR Part 11 / EU Annex 11 management.
EP2AS VAL — VALIDATION REPORT (CSV / ANNOTATED PDF)
Key Features
Automatic validation against PMDA, FDA, and EMA regional rules
Automated checks for eCTD regulatory compliance
Bulk validation of PDF page requirements, bookmarks, and links
Font and image resolution checks with suggested corrections
Automated GxP (GMP/GCP/GLP) compliance validation
Support for computerized system validation (CSV)
21 CFR Part 11 / EU Annex 11 compliance management
Automated processing via integration with document management and rendition systems
Where eP2AS VAL Fits In
Quality Assurance & Manufacturing Teams
Automated GxP compliance validation and computerized system validation (CSV) management streamline the effort required for audit readiness.
Regulatory Publishing Teams
Run bulk, rule-based validation of page requirements, bookmarks, and links across PDFs converted from Word — closing the gaps manual checks tend to miss.
Teams Filing Across Multiple Regions
Automated validation against PMDA, FDA, and EMA rules delivers consistent quality without needing to track each region’s requirements separately.
eP2AS VAL provides rule-based automatic validation and correction. For new inquiries, we recommend Miyabira Publish, which covers everything from SR conversion through to publishing in a single workflow. If you’d like to combine this with generative-AI-driven validation and correction, a hybrid approach with AiX is also available. For a broader foundation supporting your entire regulatory operations, explore Miyabira.