Pharma Compliance Modernization: Validating Legacy Workflows via Video Evidence

The $3.6 trillion global technical debt isn't just a balance sheet liability—in the pharmaceutical industry, it’s a patient safety risk and a compliance bottleneck. For CTOs and Enterprise Architects in life sciences, the mandate is clear: modernize or face catastrophic regulatory failure. Yet, 70% of legacy rewrites fail or exceed their timelines, often because the "source of truth" for business logic is buried in undocumented codebases that haven't been touched in a decade.

TL;DR: Pharma Compliance Modernization can be accelerated by 70% using visual reverse engineering to extract validated workflows directly from user interactions, replacing manual code archaeology with verifiable video evidence.

The High Cost of Documentation Gaps in GxP Systems#

In a regulated GxP environment, if it isn't documented, it didn't happen. However, 67% of legacy systems lack up-to-date documentation. When a system governing drug manufacturing or clinical trial data needs an upgrade, architects are forced into "software archaeology"—manually tracing thousands of lines of COBOL, Delphi, or legacy Java to understand the underlying business rules.

The traditional "Big Bang" rewrite approach is a suicide mission for Pharma. An 18-month average enterprise rewrite timeline usually stretches to 36 months when the complexity of 21 CFR Part 11 compliance is factored in. Every manual screen recreation takes approximately 40 hours of engineering time. This is where Replay shifts the paradigm, reducing that 40-hour window to just 4 hours by using video as the primary source of truth.

The Modernization Matrix: Comparing Approaches#

Validating Legacy Workflows via Video Evidence#

The core challenge in Pharma Compliance Modernization is proving to auditors that the new system behaves exactly like the old one. Traditional methods rely on requirements documents that are often out of sync with the actual production environment.

Replay changes the "source of truth" from a static document to a recorded workflow. By recording a real user performing a validated process—such as a batch release or a quality control check—Replay captures the exact state changes, API calls, and UI logic.

💡 Pro Tip: In highly regulated environments, use Replay to record "Golden Path" workflows. These recordings serve as both the blueprint for the new React components and the evidence for your validation package.

From Black Box to Documented Codebase#

When you record a workflow in Replay, the platform doesn't just "film" the screen. It performs deep inspection of the DOM and network layers to generate modern, clean React components and API contracts. This eliminates the risk of missing "hidden" business logic—those edge cases that only exist in the code and aren't documented anywhere else.

typescript
// Example: Generated React component from Replay video extraction
// This component preserves legacy validation logic while using modern hooks
import React, { useState, useEffect } from 'react';
import { TextField, Button, Alert } from '@mui/material';

export const GxPComplianceForm = ({ initialData, onValidate }) => {
  const [formData, setFormData] = useState(initialData);
  const [isValidated, setIsValidated] = useState(false);

  // Business logic extracted from legacy workflow:
  // "If BatchID starts with 'QC', secondary verification is mandatory."
  const handleValidation = () => {
    if (formData.batchId.startsWith('QC') && !formData.verifierId) {
      return alert("Secondary Verifier Required for QC batches");
    }
    setIsValidated(true);
    onValidate(formData);
  };

  return (
    <div className="modern-container">
      <TextField 
        label="Batch ID" 
        value={formData.batchId} 
        onChange={(e) => setFormData({...formData, batchId: e.target.value})}
      />
      {/* Modernized UI with preserved legacy constraints */}
      <Button onClick={handleValidation} variant="contained">
        Submit to Quality Assurance
      </Button>
    </div>
  );
};

The Three Pillars of Visual Reverse Engineering#

To achieve Pharma Compliance Modernization at scale, Enterprise Architects must move away from manual screen-by-screen reconstruction. Replay's architecture is built on three specific pillars that cater to the rigors of the life sciences industry.

1. The Library (Design System)#

Legacy Pharma systems often suffer from "UI Drift"—multiple versions of the same button or form across different modules. Replay's Library automatically identifies these patterns during the recording phase, consolidating them into a unified, accessible Design System. This ensures that the modernized application maintains a consistent, validated interface.

2. Flows (Architecture Mapping)#

Understanding how data moves from a legacy terminal to a modern SQL database is critical. Replay maps these "Flows" visually. Instead of reading a 400-page technical specification, architects can see a visual map of the user journey, complete with the underlying API contracts required to support it.

3. Blueprints (The Editor)#

The Blueprint is where the extraction happens. It provides a side-by-side view of the legacy recording and the generated modern code. This is the ultimate tool for compliance officers, as it provides a direct link between the "as-is" state and the "to-be" state.

⚠️ Warning: Do not attempt to modernize legacy business logic without first capturing the underlying API contracts. Relying on UI-only extraction leads to "hollow" applications that fail during integration testing.

Step-by-Step: Modernizing a Validated Workflow#

Step 1: Assessment and Scoping#

Identify the high-risk, high-value workflows. In Pharma, these are typically the modules associated with Manufacturing Execution Systems (MES) or Laboratory Information Management Systems (LIMS). Use Replay's Technical Debt Audit feature to quantify the complexity of these screens.

Step 2: Recording the "Source of Truth"#

A Subject Matter Expert (SME) performs the validated task while Replay records the session. This isn't just a screen recording; the platform captures:

• •Every DOM mutation
• •All XHR/Fetch requests
• •Local storage and session state
• •CSS styles and computed properties

Step 3: Extraction and Code Generation#

Replay’s AI Automation Suite processes the recording. Within minutes, it generates a React component that mirrors the legacy functionality but utilizes modern coding standards (TypeScript, Functional Components, Hooks).

json
// Example: Generated API Contract from Replay extraction
// This allows backend teams to build compatible endpoints immediately.
{
  "endpoint": "/api/v1/batch-release",
  "method": "POST",
  "headers": {
    "Content-Type": "application/json",
    "X-GxP-Audit-Trail": "Required"
  },
  "payload_schema": {
    "type": "object",
    "properties": {
      "batch_id": { "type": "string", "pattern": "^[A-Z]{2}-[0-9]{6}$" },
      "timestamp": { "type": "string", "format": "date-time" },
      "action": { "enum": ["RELEASE", "HOLD", "REJECT"] }
    },
    "required": ["batch_id", "action"]
  }
}

Step 4: Validation and E2E Testing#

Replay automatically generates End-to-End (E2E) tests based on the recorded workflow. For Pharma, this is the "Golden Ticket." You now have a test suite that proves the new system handles the exact same inputs and outputs as the legacy system, satisfying IQ/OQ/PQ (Installation, Operational, and Performance Qualification) requirements.

💰 ROI Insight: By automating the generation of E2E tests and documentation, Replay users report an average of 70% time savings on the total project lifecycle, moving from an 18-month roadmap to a 6-month delivery.

Addressing the "Black Box" Concern#

The biggest fear for a VP of Engineering in a regulated industry is the "Black Box" logic—the proprietary calculation or data transformation hidden in a legacy DLL or a 20-year-old stored procedure.

Visual reverse engineering addresses this by focusing on the observable behavior and the data contract. By capturing the exact data sent to and from the legacy backend, Replay allows you to isolate the business logic. You can then choose to keep the legacy backend (Strangler Fig pattern) or rewrite the microservice with a clear understanding of the expected inputs and outputs.

📝 Note: Replay is built for regulated environments. It offers SOC2 compliance, is HIPAA-ready, and can be deployed On-Premise to ensure that sensitive clinical or manufacturing data never leaves your secure network.

Frequently Asked Questions#

How does Replay handle complex legacy logic that isn't visible on the screen?#

Replay captures the entire network layer and state transitions. If the legacy system performs a calculation on the backend, Replay documents the API request and the resulting response. This creates a "black box" specification that your backend team can use to replicate the logic in a modern language like Go or Node.js without needing to read the original legacy source code.

Can we use Replay for systems that are strictly on-premise?#

Yes. We understand that Pharma and Government sectors often have air-gapped or highly restricted environments. Replay offers an On-Premise deployment model that allows you to record and extract components within your own infrastructure, maintaining total data sovereignty.

How does this impact the Validation Master Plan (VMP)?#

Replay significantly streamlines the VMP. Because the platform generates documentation and E2E tests directly from the recorded "source of truth," the manual effort required for User Acceptance Testing (UAT) and functional verification is slashed. The video recording itself becomes a piece of objective evidence for auditors.

Does Replay work with legacy technologies like Silverlight or Flash?#

Yes. Replay’s visual extraction engine is designed to interpret the rendered output of legacy web technologies, converting them into modern, standards-compliant React components. This is particularly useful for Pharma companies stuck on old versions of Internet Explorer due to legacy plugin dependencies.

The Future of Modernization is Understanding#

The era of the "Big Bang" rewrite is over. The risks are too high, and the costs are too great, especially in the pharmaceutical sector where compliance is non-negotiable. The future of enterprise architecture isn't about throwing away the past; it's about understanding what you already have and extracting its value into a modern stack.

By leveraging Replay, organizations can stop the cycle of failed rewrites and documentation archaeology. They can move from a black box to a fully documented, modern codebase in weeks, not years.

---

Ready to modernize without rewriting? Book a pilot with Replay - see your legacy screen extracted live during the call.