SAP S/4HANA represents one of the most significant ERP transformations in the pharmaceutical and life sciences industry. With mainstream maintenance for predecessor SAP products ending in 2027, organizations face the challenge of validating complex S/4HANA implementations while maintaining regulatory compliance with GAMP 5, 21 CFR Part 11, and EU GMP Annex 11.
Valkit.ai is a cloud-based Software as a Service (SaaS) platform that uses dynamic automations and user-directed contextual AI augmentation to improve the quality and delivery of commissioning, qualification, and validation. The platform requires minimal initial configuration and is designed to be implemented rapidly with low ongoing maintenance requirements from a customer perspective.
Hugh DevineĀ·
Valkit.ai for SAP S/4HANA Validation
Accelerating GxP Computer System Validation
with AI-Powered Automation
Solution Overview & Technical Guide
Legal Notice
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Valkit.ai is not affiliated with, endorsed by, or formally associated with SAP SE or any other third-party application, product, or service referenced herein. Any reference to third-party products or services is provided solely for informational purposes and does not constitute or imply endorsement, sponsorship, or recommendation.
The information in this document is provided for general guidance purposes only and should not be construed as legal, regulatory, or compliance advice.
1. Executive Summary
SAP S/4HANA represents one of the most significant ERP transformations in the pharmaceutical and life sciences industry. With mainstream maintenance for predecessor SAP products ending in 2027, organizations face the challenge of validating complex S/4HANA implementations while maintaining regulatory compliance with GAMP 5, 21 CFR Part 11, and EU GMP Annex 11.
Valkit.ai is a cloud-based Software as a Service (SaaS) platform that uses dynamic automations and user-directed contextual AI augmentation to improve the quality and delivery of commissioning, qualification, and validation. The platform requires minimal initial configuration and is designed to be implemented rapidly with low ongoing maintenance requirements from a customer perspective.
Key validation challenges addressed include managing complex configuration decisions, ensuring traceability across GxP-relevant modules (QM, MM, PP, PM, WM, SD), and maintaining compliance through iterative implementation phases.
2. Platform Benefits
2.1 Rapid Implementation, Minimal Maintenance
Valkit.ai is purpose-built for quick deployment into GxP-supportive business workflows. The platform requires minimal initial configurationāusers can begin creating validation packages immediately without extensive setup or customization. Once implemented, the system is designed to operate with low to no ongoing maintenance burden on customer IT or quality teams, allowing organizations to focus on their validation activities rather than platform administration.
2.2 AI-Powered Automation
The platform automates key validation activities that traditionally require significant manual effort:
Requirements Processing: Paste mixed inputs and AI transforms them into structured specifications
Automatic Risk Scoring: Risk entries created and scored as specifications are added
Trace Matrix Generation: Traceability links created automatically
Test Case Creation: AI-assisted test step generation based on requirements
3. Requirements Extraction and Structuring
3.1 AI-Powered Requirements Processing
Valkit.ai enables users to extract, structure, and formulate User Requirements from diverse input sources. Users paste mixed inputsābusiness process documents, functional specifications, workshop outputs, configuration notesāinto the platform where the agentic AI transforms them into structured, testable specifications.
How It Works
Paste input content into the Valkit.ai interface (process flows, business requirements, technical notes)
The AI analyzes content and generates structured specifications
Each specification receives a unique identifier (e.g., REQ-1-001)
Automatic risk entry is created and scored
Trace matrix entry is automatically generated
3.2 Ensuring Testability, Completeness, and Consistency
As specifications are added to the validation package, the system automatically ensures:
Testability: Each requirement is structured to be verifiable through test execution
Completeness: Coverage indicators show which requirements have risks and test steps assigned
The system supports manual addition, upload, or AI-based generation of requirements. Tags can be imported from third-party applications via CSV file drag-and-drop and are immediately available for organizational or package use.
4. Functional Risk Analysis
4.1 Automatic Risk Assessment
Functional risk analysis integrates automatically with requirements management. When specifications are added, risk entries are created and scored without manual intervention. The risk assessment follows FDA FICSA team recommendations, codified in the ISPE GAMP Data Integrity by Design good practice guide.
4.2 Risk Rating Methodology
The platform employs a five-level, three-attribute risk rating model. Risk scores (1-5) are automatically derived based on two critical factors:
Impact Severity
Implementation Complexity
Direct: Patient, product, or regulatory impacts
Custom: Highest risk - custom code developed
Indirect: Secondary impacts on quality systems
Configured: Medium risk - standard configuration
None: No GxP impact identified
Out of the Box: Lowest risk - standard functionality
4.3 Risk Score Matrix
Score
Impact
Implementation
Testing Approach
5
Direct
Custom
Comprehensive validation
4
Direct / Indirect
Configured / Custom
Substantial testing
3
Indirect / Direct
Configured / OOB
Moderate attention
2
None
Custom
Limited scripting
1
None
OOB / Configured
Basic test step
5. Test Case Generation
5.1 Risk-Based Testing Approach
The outcome of the risk assessment forms the basis for testing. Higher risk requirements receive more rigorous testing than those assessed as lower risk. The scripting engine enables comprehensive test writing based on the risk assessment.
5.2 AI-Assisted Test Step Creation
To generate test cases in an SAP environment based on requirements or process flows:
Select one or more requirements from the requirements document
Click "Generate Test Step" or "AI Generate"
AI creates comprehensive test steps that verify all selected requirements
Test steps follow regulatory guidelines and include proper methodology
Linked Requirements: Which requirements this verifies
Risk Rating: Based on linked requirements
Evidence: Photos, files, data captured during execution
6. End-to-End Traceability
6.1 Automatic Trace Matrix Generation
The trace matrix maintains complete traceability from URS through specification, risk analysis, test cases, and test resultsāall automatically. Once you select the specifications you want to test, the system links them to the trace matrix. No configuration is required beyond selecting which documents you want in your validation package.
6.2 How Traceability Is Created
Links are automatically created when you:
Link requirements to risk assessments
Link requirements to test steps
Use AI generation (AI-generated test steps automatically link to requirements)
6.3 Traceability Framework
The following table shows how validation elements are automatically linked:
Validation Element
Automatic Linkage
User Requirements (URS)
Links to specifications and risk assessments
Specifications
Links to requirements, creates risk entry, adds trace matrix entry
Risk Analysis
Automatically scored, links to requirements
Test Cases
Links to requirements, risk ratings determine test depth
Test Results
Captured with evidence, linked to test cases and requirements
6.4 Coverage Indicators
The system provides coverage indicators to identify gaps: Fully Covered (requirement has both risks and test steps), Partially Covered (requirement has risks or test steps, but not both), and Not Covered (requirement has no links).
7. Configuration Documentation
7.1 Data Capture Tables
For SAP S/4HANA where configuration documentation is central, Valkit.ai's Data Capture Tables provide structured data entry forms. These tables become part of the master data library and can be recalled as needed for configuration parameter decisions and module-specific design details.
Creating Configuration Tables
Navigate to a test step or section in Draft mode
Click "Add Data Capture" to open the Data Capture modal
Define columns with appropriate types (Text, Number, Date, Dropdown)
Specifications can be linked togetherāto requirements, to other specifications, to test cases. When you create these links, all connected items automatically appear in the trace matrix. While auto-linking is not currently available, the manual linking process ensures comprehensive traceability between configuration items, User Requirements, and test scenarios.
7.3 Master Data and Tag Management
Tags capture metadata about software, equipment, lab instruments, and process activities:
Tag customization with location, serial number, asset tag, model number
Tag content permeates through all indicated documents automatically
Tag value updates cascade through all documents in draft state
Tags can be embedded within table structures
8. Managing Iterative Implementation
8.1 Changes During Build/Fine-Tuning Phases
SAP S/4HANA implementations involve iterative build and fine-tuning phases. Valkit.ai supports these through automated tag cascade updates, version control with status history, and deviation management.
8.2 Package Cloning
For like-for-like validation scenarios (e.g., multiple SAP modules with similar requirements), packages can be cloned with full customization in less than 5 minutes. Cloned packages include:
All document types and structure
Requirements and risk assessments
Test cases and test steps
Traceability links
Data capture tables (optional)
8.3 Deviation Management
The system initiates deviation management with complete documentation. Deviations are detected and logged, classified by type, assessed for impact, and tracked through corrective actions and resolution verification.
9. Regulatory Compliance
9.1 21 CFR Part 11 Compliance
Valkit.ai provides comprehensive support for FDA electronic records and signatures requirements:
Electronic records used in lieu of paper records with full regulatory compliance
Authority checks ensuring only authorized individuals can sign, alter, or access records
Audit trails available for agency review and copying
Electronic signatures for validation documents
Mechanisms for creating, modifying, maintaining, archiving, retrieving, and distributing electronic records
9.2 EU GMP Annex 11 Compliance
The platform supports compliance with EU GMP Annex 11 requirements for computerized systems:
Risk Management: Risk-based validation approach with documented risk assessments covering patient safety, product quality, and data integrity
Personnel: Defined roles and responsibilities with role-based access controls (Author, Review, Execute, Approve)
Validation: Complete validation lifecycle documentation with traceable requirements and test evidence
Data: Data integrity controls ensuring accuracy, completeness, and consistency throughout the record lifecycle
Accuracy Checks: Structured test execution with expected results verification and evidence capture
Data Storage: Secure cloud storage with backup and recovery capabilities
Printouts: Export to multiple formats for regulatory submissions and audits
Audit Trail: Complete, unalterable audit trail recording all changes to validation documents
Change Management: Version control and status history ensuring documented, authorized changes
Security: Access controls, authentication, and procedures to ensure confidentiality
9.3 GAMP 5 Alignment
The platform's validation methodology aligns with ISPE GAMP 5 Second Edition guidance. The functional risk assessment methodology follows FDA FICSA team recommendations as codified in the GAMP Data Integrity by Design good practice guide, employing risk-based approaches to focus validation effort on critical aspects of computerized systems.
10. Validation Package Deliverables
A typical SAP S/4HANA validation package in Valkit.ai includes:
Document
Abbreviation
Purpose
Validation Plan
VP
Define validation strategy
Product Requirements
PRD
Document requirements
Functional Risk Assessment
FRA
Assess and score risks
Operational Qualification
OQ
Test scripts and execution
Trace Matrix
TMX
Link requirements to tests
Validation Summary Report
VSR
Summarize activities
All documents support electronic signatures in compliance with 21 CFR Part 11 and EU GMP Annex 11, with defined stakeholder roles (Author, Review, Execute, Approve) and complete audit trails.
11. Summary
Valkit.ai provides an efficient, automated approach to SAP S/4HANA validation that reduces manual effort while ensuring regulatory compliance. With minimal initial configuration, rapid implementation, and low ongoing maintenance requirements, the platform enables organizations to focus on their validation activities rather than system administration.
The automatic risk assessment, traceability matrix generation, and AI-assisted test case creation address the key challenges of complex ERP validation projects while maintaining compliance with 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 requirements.
