QualiVeil Knowledge Base

Comprehensive documentation for pharmaceutical data validation and HIPAA compliance

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Getting Started

Platform Overview

QualiVeil is a comprehensive pharmaceutical data validation platform that validates data at the source before it breaks your pipeline.

  • Secure pharmaceutical data collaboration
  • HIPAA-compliant tokenization
  • Real-time data quality management
  • Enterprise-grade workflow automation
Data Flow Process
  1. 1Manufacturers create data contracts
  2. 2Suppliers upload CSV/Excel files
  3. 3Automatic validation against contracts
  4. 4Exception handling for data quality
  5. 5HIPAA-compliant tokenization
  6. 6Final dataset repository storage

Supplier Features

File Format Support:
  • CSV Files: Standard comma-separated values
  • Excel Files: .xlsx and .xls formats supported
  • Pipe-Delimited: .txt files with pipe (|) separators
  • Large Datasets: Support for 100k+ records
Data Preview Features:
  • Inline Editing: Edit data directly in the preview table
  • Smart Cell Locking: Prevents accidental edits to complete data
  • Real-time Tokenization: See how PII fields will be tokenized
  • Compliance Verification: Automatic contract compliance checking

Data Quality Management:
  • Automatic Detection: System identifies missing or incomplete data
  • Progressive Disclosure: See exactly which patients need corrections
  • Restatement Workflow: Submit corrected data files
  • Template Downloads: Get pre-filled templates for corrections
Notification System:
  • Real-time Alerts: 2-3 second notification delivery
  • Restatement Requests: Manufacturer data completion requests
  • Status Updates: Track approval progress

Restatement Process:
  • Smart Templates: Download templates with only missing fields
  • Partial Corrections: Submit corrections for specific patients
  • Merge Logic: System combines original + corrected data
  • Validation: Automatic validation of corrected data
Upload Corrected Data Modal:
  • Field Guidance: Clear instructions for required fields
  • Format Examples: Sample data format guidance
  • Tokenization Options: Enable/disable tokenization
  • Notes System: Add context for manufacturers

Manufacturer Features

Contract Creation:
  • Field Specifications: Define required data fields
  • Validation Rules: Set compliance requirements
  • PII Classification: Specify which fields need tokenization
  • Contract Templates: Reusable contract patterns (test9f, test12f, test21f)
Supplier Distribution:
  • Send to Suppliers: Distribute contracts to data suppliers
  • Contract Repository: Track sent contracts and status
  • Version Control: Manage contract updates and revisions

Exception Review:
  • Pending Exceptions: Review data quality issues
  • Field Completeness: See completion percentages by field
  • Priority Classification: High/Medium/Low priority exceptions
  • Bulk Operations: Manage multiple exceptions
Supplier Restatements:
  • Restatement Review: Streamlined table with essential columns
  • Accept/Reject: Approve supplier corrections
  • Quality Analysis: Detailed data quality improvements
  • Automated Cleanup: Notifications clear automatically

Available Datasets:
  • Approved Data: Final tokenized datasets ready for download
  • CSV Downloads: Complete merged datasets with all corrections
  • Quality Scores: 100% completion indicators
  • Record Counts: Accurate patient/record counts
Dataset Management:
  • Metadata Tracking: Contract names, suppliers, dates
  • Compliance Status: HIPAA compliance verification
  • Version History: Track dataset updates and changes

Tokenization System

Deterministic Tokenization

Our unified tokenization engine ensures consistent token generation across all platform workflows.

Key Features:
  • HMAC-SHA256 algorithm
  • Field-specific prefixes (FN_, LN_, DOB_, etc.)
  • Consistent tokens for same input
  • Cross-dataset patient tracking
Token Consistency

Tokens shown in Data Preview exactly match tokens in final manufacturer downloads.

Field Prefixes:
  • FN_ FirstName (e.g., FN_4A8A9EC2)
  • LN_ LastName (e.g., LN_524435EB)
  • DOB_ DateOfBirth (e.g., DOB_320F5CB9)
  • PH_ PhoneNumber (e.g., PH_D28F61A6)
  • EM_ Email (e.g., EM_D6FD7E9E)
  • ADDR_ Address (e.g., ADDR_3AE1C5BF)

HIPAA Compliance

Data Protection
  • Supplier-side tokenization only
  • No raw PII reaches manufacturers
  • Secure session management
  • Encrypted data transmission
De-identification
  • HIPAA Safe Harbor compliance
  • Patient re-identification prevention
  • Consistent patient journey tracking
  • Cross-study linkage capability
Audit Trail
  • Complete processing logs
  • Exception tracking
  • User action monitoring
  • Compliance verification

Troubleshooting

File Upload Issues:
  • Large Files: Files over 100k records may take longer to process
  • Format Errors: Ensure CSV/Excel files are properly formatted
  • Column Mismatch: Verify field names match contract specifications
Tokenization Issues:
  • Inconsistent Tokens: Hard refresh browser (Ctrl+F5) after updates
  • Missing Tokens: Ensure PII fields are properly classified in contract
  • Token Format: Tokens follow pattern: PREFIX_XXXXXXXX

Optimal File Sizes:
  • Recommended: 10k-50k records per file
  • Maximum: 100k+ records supported with longer processing
  • Format Choice: CSV files process faster than Excel
Browser Optimization:
  • Cache Clearing: Use Ctrl+F5 for hard refresh after updates
  • Session Management: Avoid multiple browser tabs
  • Memory Usage: Close other applications for large file processing

Platform Status:
  • Health Check: Use /health endpoint to verify system status
  • Reset Data: Use Reset Test Data for clean environment
  • Session Issues: Clear browser cache and retry
Documentation:
  • Architecture: See HIPAA_DEIDENTIFICATION_PLATFORM_ARCHITECTURE.md
  • Recent Changes: Check replit.md for latest updates
  • Workflow Diagram: Visit /workflow for visual process guide