Success Story:
Validation (CSV) of a Complex Enterprise Solution for a Pharma Giant
Challenges
InspireXT assisted a global veterinary pharmaceutical manufacturing giant in implementing a validated Oracle Cloud Supply Chain and Manufacturing solution in a Process Manufacturing environment as per the cGMP guidelines ensuring system compliance to international regulations such as FDA 21 CFR Part 11.
- Implementation Complexity: Deploying and validating a large-scale SaaS manufacturing and distribution system across multiple sites was time-consuming and difficult to manage.
- Compliance Overhead: Exhaustive documentation and testing to meet regulatory standards drained resources and caused delays.
- Traceability Gaps: Managing diverse user requirements across implementation phases, with appropriate GxP categorisation, created traceability challenges.
- Manual Testing Burden: Extensive manual testing across multiple modules slowed timelines, increased costs, and raised error risks.
- Inefficient Paper Validation: Paper-based validation processes were slow, hard to manage remotely, and hindered scalability.
Solution
Global Design and Validation: A global design solution was implemented with site-specific requirements, using a risk-based validation strategy across GxP and non-GxP modules. This covered Infrastructure Qualification, Installation Qualification (IQ), Operational Qualification (OQ/SIT), and Performance Qualification (PQ/UAT).
User Requirements and Testing: User requirements were categorised by GxP modules, with a User Requirements Specification (URS) developed for each. Test scripts were designed and executed based on risk assessment to ensure all requirements were met.
Risk Management: A risk assessment using FMEA prioritised critical system components, guiding testing efforts. Validation phases, including Infrastructure, Installation Qualification, Operational Qualification, and Performance Qualification, confirmed business needs.
Compliance and Digital Validation: The Oracle Cloud system was configured to comply with FDA 21 CFR Part 11 for electronic signatures, audit trail and data integrity. A digital validation tool was implemented to streamline test activities, with thorough documentation including test plans, protocols, reports, and deviations supporting compliance in deploying solution to Production environment.
Training and Change Management: A training plan ensured users understood system navigation, compliance, and error reporting. A structured change management process ensured future system updates were tested and documented for compliance.
Continuous Validation for quarterly system updates: The quarterly updates to the Oracle Cloud system are managed by adopting a risk-based methodology for the changes to be implemented. An automated regression suite enables the swift testing and documentation. This ensures that the system remains in a continuous validated state.
Solution Components
- Requirements review
- Adopting standard processes for GMP
- Risk Assessment
- Validation Strategy
- Digital / Paperless Validation
- Validation Documentation
- Deviation Management
- Change Control Management
- Quarterly Update analysis and management
- Automated Regression Testing
Results
Regulatory Compliance & Readiness: System implemented in the first site, fully validated for compliance and operational readiness. Deployment in other sites underway.
Project Efficiency: Streamlined validation kept stakeholders aligned, ensuring timely project completion.
Faster Go-Live: Risk-based UAT expedited go-live, driving quicker business value realisation.
Audit-Ready Assurance: Documentation ensured compliance with regulatory bodies, minimising audit risks.
Efficient Test Management: Digital validation tool reduced validation time and effort, boosting efficiency.
Seamless System Upgrades: Automated regression suite enabled smooth quarterly updates with minimal disruption.
The Opportunity
InspireXT assisted a global veterinary pharmaceutical manufacturing giant in implementing a validated Oracle Cloud Supply Chain and Manufacturing solution in a Process Manufacturing environment as per the cGMP guidelines ensuring system compliance to international regulations such as FDA 21 CFR Part 11.
- Implementation Complexity: Deploying and validating a large-scale SaaS manufacturing and distribution system across multiple sites was time-consuming and difficult to manage.
- Compliance Overhead: Exhaustive documentation and testing to meet regulatory standards drained resources and caused delays.
- Traceability Gaps: Managing diverse user requirements across implementation phases, with appropriate GxP categorisation, created traceability challenges.
- Manual Testing Burden: Extensive manual testing across multiple modules slowed timelines, increased costs, and raised error risks.
- Inefficient Paper Validation: Paper-based validation processes were slow, hard to manage remotely, and hindered scalability.
The Solution
Global Design and Validation: A global design solution was implemented with site-specific requirements, using a risk-based validation strategy across GxP and non-GxP modules. This covered Infrastructure Qualification, Installation Qualification (IQ), Operational Qualification (OQ/SIT), and Performance Qualification (PQ/UAT).
User Requirements and Testing: User requirements were categorised by GxP modules, with a User Requirements Specification (URS) developed for each. Test scripts were designed and executed based on risk assessment to ensure all requirements were met.
Risk Management: A risk assessment using FMEA prioritised critical system components, guiding testing efforts. Validation phases, including Infrastructure, Installation Qualification, Operational Qualification, and Performance Qualification, confirmed business needs.
Compliance and Digital Validation: The Oracle Cloud system was configured to comply with FDA 21 CFR Part 11 for electronic signatures, audit trail and data integrity. A digital validation tool was implemented to streamline test activities, with thorough documentation including test plans, protocols, reports, and deviations supporting compliance in deploying solution to Production environment.
Training and Change Management: A training plan ensured users understood system navigation, compliance, and error reporting. A structured change management process ensured future system updates were tested and documented for compliance.
Continuous Validation for quarterly system updates: The quarterly updates to the Oracle Cloud system are managed by adopting a risk-based methodology for the changes to be implemented. An automated regression suite enables the swift testing and documentation. This ensures that the system remains in a continuous validated state.
Solution Components
- Requirements review
- Adopting standard processes for GMP
- Risk Assessment
- Validation Strategy
- Digital / Paperless Validation
- Validation Documentation
- Deviation Management
- Change Control Management
- Quarterly Update analysis and management
- Automated Regression Testing
The Outcome
- Regulatory Compliance & Readiness: System implemented in the first site, fully validated for compliance and operational readiness. Deployment in other sites underway.
- Project Efficiency: Streamlined validation kept stakeholders aligned, ensuring timely project completion.
- Faster Go-Live: Risk-based UAT expedited go-live, driving quicker business value realisation.
- Audit-Ready Assurance: Documentation ensured compliance with regulatory bodies, minimising audit risks.
- Efficient Test Management: Digital validation tool reduced validation time and effort, boosting efficiency.
- Seamless System Upgrades: Automated regression suite enabled smooth quarterly updates with minimal disruption.
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