Pharma Regulatory Submission Modernization: Reducing Validation Time by 75% via Visual Evidence

The average pharmaceutical company spends 24 months modernizing a legacy submission portal, only to find that 40% of the budget was consumed by validation documentation that became obsolete before the system went live. In a sector where 21 CFR Part 11 compliance is non-negotiable, the "Validation Tax" on software modernization has historically been the primary inhibitor of innovation. We are currently witnessing a $3.6 trillion global technical debt crisis, and nowhere is this more felt than in Life Sciences, where 67% of legacy systems lack any form of accurate documentation.

To stay competitive, the industry must pivot toward pharma regulatory submission modernization strategies that prioritize visual evidence and automated reverse engineering over manual, error-prone documentation.

TL;DR: Pharma enterprises are trapped in a cycle of manual GxP validation that extends modernization timelines to 18-24 months. By using Replay and its Visual Reverse Engineering engine, organizations can reduce screen-to-code time from 40 hours to 4 hours. This approach uses video recordings of legacy workflows to automatically generate documented React components and design systems, slashing validation time by 75% and ensuring 100% architectural fidelity.

The Validation Bottleneck in Pharma Regulatory Submission Modernization#

Traditional modernization efforts in Life Sciences follow a predictable, albeit broken, path. A team identifies a legacy COBOL or Java-based submission system that is no longer supported. They spend six months "discovering" requirements by interviewing users who have forgotten why certain buttons exist. They then spend another year manually rewriting the UI in a modern framework like React, followed by a grueling six-month validation phase where every screen, state, and edge case must be documented for regulatory auditors.

According to Replay’s analysis, 70% of these legacy rewrites fail or significantly exceed their timelines because the delta between the "documented" intent and the "actual" legacy behavior is too wide.

Video-to-code is the process of capturing real-time user interactions with a legacy system and using AI-driven visual analysis to generate functional, production-ready code that mirrors the original system's logic and aesthetics.

By leveraging Visual Reverse Engineering, pharma companies can bypass the discovery phase entirely. Instead of guessing how a complex regulatory form handled multi-part file uploads in 2004, they can record a 30-second video of the process.

Why Legacy Documentation is the Enemy of Compliance#

Industry experts recommend moving away from "static documentation" toward "executable evidence." When 67% of legacy systems lack documentation, the "source of truth" isn't a PDF buried in SharePoint—it is the running application itself.

In the context of pharma regulatory submission modernization, manual documentation is a liability. If a developer manually recreates a validation logic for an IND (Investigational New Drug) application and misses a single edge case, the regulatory submission could be rejected, costing the firm millions in delayed market entry.

The Cost of Manual Modernization vs. Replay#

Implementing Pharma Regulatory Submission Modernization with React#

To modernize a regulatory portal, you need more than just a fresh coat of paint. You need a robust Design System and a component library that adheres to strict validation rules. Replay’s "Library" feature allows teams to extract components directly from video recordings, ensuring that the new React-based UI is a pixel-perfect, logic-perfect successor.

Below is an example of a modernized Regulatory Submission Component generated through Replay's blueprinting engine. Note the inclusion of audit-ready state management and standardized validation.

typescript
// Modernized Regulatory Submission Component
// Generated via Replay Blueprints from Legacy Recording
import React, { useState, useEffect } from 'react';
import { Button, TextField, Alert, AuditTrail } from '@pharma-ds/core';

interface SubmissionProps {
  submissionId: string;
  initialData: any;
  onValidate: (data: any) => Promise<boolean>;
}

export const RegulatorySubmissionForm: React.FC<SubmissionProps> = ({ 
  submissionId, 
  initialData, 
  onValidate 
}) => {
  const [formData, setFormData] = useState(initialData);
  const [isValidating, setIsValidating] = useState(false);
  const [error, setError] = useState<string | null>(null);

  const handleFieldChange = (field: string, value: string) => {
    setFormData({ ...formData, [field]: value });
    // Audit capture for GxP compliance
    AuditTrail.logChange(submissionId, field, value);
  };

  const handleSubmit = async () => {
    setIsValidating(true);
    const success = await onValidate(formData);
    if (!success) {
      setError("Validation failed: Ensure all 21 CFR Part 11 requirements are met.");
    }
    setIsValidating(false);
  };

  return (
    <div className="submission-container">
      <h3>Modernized Submission Portal - ID: {submissionId}</h3>
      <TextField 
        label="Compound ID" 
        value={formData.compoundId} 
        onChange={(e) => handleFieldChange('compoundId', e.target.value)}
      />
      <TextField 
        label="Protocol Number" 
        value={formData.protocolNumber} 
        onChange={(e) => handleFieldChange('protocolNumber', e.target.value)}
      />
      {error && <Alert severity="error">{error}</Alert>}
      <Button 
        onClick={handleSubmit} 
        loading={isValidating}
        variant="primary"
      >
        Verify & Submit to Vault
      </Button>
    </div>
  );
};

Automating the "Flows" of Submission#

Pharma workflows are rarely linear. A single regulatory submission might involve dozens of conditional branches based on the therapeutic area or the target country’s requirements. Replay’s "Flows" feature maps these architectural pathways by analyzing recorded user sessions.

Instead of a business analyst drawing a flowchart that might be wrong, Replay generates the architecture based on what the legacy system actually did. This is the cornerstone of effective pharma regulatory submission modernization.

Learn more about mapping complex application flows

The Role of AI in Validation Evidence#

In a regulated environment, you cannot simply tell an auditor, "The AI wrote the code." You need a trail. Replay provides "Blueprints," which serve as the bridge between the legacy recording and the generated code.

When a developer uses Replay to modernize a screen, the platform maintains a link between the video frame (the evidence) and the React component (the output). This creates an automated traceability matrix. According to Replay's analysis, this visual evidence reduces the time spent in Quality Assurance (QA) by up to 75% because the "correctness" of the UI is visually verifiable against the legacy recording.

Standardizing the Design System#

One of the biggest risks in pharma regulatory submission modernization is "fragmentation debt"—where different teams build different parts of the submission suite using different UI patterns. Replay’s AI Automation Suite extracts a unified Design System from your legacy recordings, ensuring that every modernized app uses the same validated component library.

typescript
// Example of a Standardized Design System Token Set
// Extracted from legacy visual patterns via Replay
export const PharmaTheme = {
  colors: {
    primary: '#004A99', // Compliant with accessibility standards
    success: '#2D8A4E',
    warning: '#E07A5F',
    background: '#F4F7F9',
  },
  spacing: {
    tight: '4px',
    base: '8px',
    large: '16px',
  },
  typography: {
    fontFamily: 'Inter, system-ui, sans-serif',
    fontSize: {
      label: '12px',
      body: '14px',
      heading: '24px',
    }
  }
};

Security and Compliance in Regulated Environments#

For industries like Healthcare and Financial Services, the cloud is often a point of contention. Replay is built for these high-stakes environments. The platform is SOC2 and HIPAA-ready, and for organizations with the strictest data sovereignty requirements, Replay offers On-Premise deployment options.

When undergoing pharma regulatory submission modernization, the data captured in recordings may contain Sensitive Personal Information (SPI) or Protected Health Information (PHI). Replay’s platform includes automated PII masking and redaction layers, ensuring that the visual evidence used for modernization never compromises patient privacy or regulatory standing.

Reducing the 18-Month Timeline#

The industry standard of 18 months for an enterprise rewrite is no longer acceptable. The speed of drug discovery, powered by AI and computational biology, is outpacing the software meant to manage its regulation.

By shifting to a Visual Reverse Engineering workflow, the timeline looks drastically different:

1. •Week 1-2: Recording & Extraction. Capture all critical paths of the legacy submission portal.
2. •Week 3-4: Component Generation. Replay generates the React library and Design System.
3. •Week 5-8: Logic Integration & Validation. Developers wire the new UI to modern APIs, using Replay’s visual evidence to expedite GxP validation.

This 70% average time savings isn't just about efficiency; it's about opportunity cost. Every month a submission portal is in "modernization limbo" is a month where regulatory overhead slows down the delivery of life-saving treatments.

How to accelerate enterprise modernization

The Future of Regulatory Software#

As we move toward more integrated digital health ecosystems, the systems we use for regulatory submissions must be modular, documented, and easy to update. The era of the "Black Box" legacy system is over. Through pharma regulatory submission modernization, companies are not just updating their tech stack; they are building a foundation for continuous compliance.

Industry experts recommend that CTOs in the pharma space audit their current technical debt. If you are sitting on a $100M+ portfolio of legacy software with no documentation, the risk of a "failed rewrite" is your biggest threat. Replay offers a path to modernization that is grounded in reality, not manual requirements gathering.

Frequently Asked Questions#

How does Replay handle 21 CFR Part 11 compliance during modernization?#

Replay facilitates compliance by providing automated visual evidence for every component generated. By linking the "as-is" state of the legacy system (via video) to the "to-be" React code, it creates an immutable traceability record that simplifies GxP validation and audit trails.

Can Replay modernize systems with no existing source code?#

Yes. Replay is a Visual Reverse Engineering platform. It does not require access to the underlying legacy source code (which is often lost or undocumented). It works by analyzing the rendered UI and user workflows, making it ideal for ancient systems where the original developers are long gone.

What is the difference between Video-to-code and standard AI code assistants?#

Standard AI assistants (like Copilot) suggest code based on patterns they've seen in other projects. Replay's Video-to-code technology generates code based on your specific legacy system's visual behavior and business logic. It ensures the output is a functional replacement for your unique environment, rather than a generic suggestion.

Does Replay support on-premise deployment for high-security pharma environments?#

Absolutely. We understand that pharma data is highly sensitive. Replay offers On-Premise and Private Cloud deployment options to ensure that all recordings and generated code remain within your secure perimeter, meeting SOC2 and HIPAA requirements.

How much time can we really save on validation?#

According to Replay's analysis, companies typically see a 75% reduction in validation time. This is achieved because the "Visual Evidence" provided by the platform replaces the need for manual screen-by-screen comparisons and hand-written functional specifications.

Ready to modernize without rewriting? Book a pilot with Replay