SAP Validation Package Development

Many businesses rely on robust and efficient Enterprise Resource Planning (ERP) systems. They streamline operations and enhance productivity. However, such systems come with common issues. Among them are:
  • The lack of comprehensive system requirements
  • Insufficient technical and quality documentation.
These can undermine the delivery effectiveness, issues' solving, audit, and compliance.
This case study delves into how we developed a SAP Validation Package to solve similar problems. The client faced significant challenges with their Global ERP system. It lacked essential documentation and had notable gaps in processes. These deficiencies impacted the system’s efficiency, reliability, and compliance with regulatory standards.
So, the primary goal was to address these issues by creating a custom SAP Validation Package. This involved:
  • Developing comprehensive documentation
  • Evaluated processes to ensure the system met both operational and compliance requirements
Over the course of ten months, the system's compliance and reliability significantly improved.
Industry
Life Sciences
Duration
10 months
Country
USA
Team
3 Functional Leads, 1 Software Developer
Problem
The client’s Global ERP system lacked essential documentation for configurations and developments. It led to incomplete validation and audit findings.
Solution
SAP validation package development.

Challenge

This project was challenging due to the focus on multiple critical aspects of the ERP system:
  • Functionality. We needed to evaluate the current system landscape, identify gaps, and address them via proper documentation and testing to meet the diverse needs of the global organization. These included modules for finance, supply chain management, human resources, and customer relationship management.
  • Reliability. The project required creating reusable testing protocols to leverage in future projects and regression testing.
  • Alignment with industry standards. The client needed to incorporate new data protection regulations and industry-specific standards such as 21 CFR part 11.
  • Cost efficiency. The client was looking for the solution delivery within their limited budget This required evaluating and implementing cost-saving measures. At the same time, we needed to do the work without compromising on essential features or system performance.
Thus, the client expected their global ERP system to become an all-encompassing tool. It was supposed to serve the organization’s current needs and future opportunities.

Solution

We developed a robust SAP validation package to maintain an efficient ERP system. It was designed to meet all technical and quality requirements. The package ensured that each component of the SAP system was tested and validated. The project went through seven phases.

1. Initial Assessment and Planning

First, we conducted an in-depth assessment of the Global ERP system to identify areas for validation and optimization. Then, our team developed a detailed project plan with timelines, resource allocation, and risk mitigation strategies.

2. Detecting Gaps in the ERP System

In collaboration with the client’s team, we documented and tested all missing processes using their Quality templates and testing tools. Then, we migrated this information into their QMS system.
We drafted comprehensive Application Lifecycle Management (ALM) scripts tailored to the specific needs of the ERP system. After that, our team conducted rigorous testing of ALM scripts to ensure they effectively validated the system’s functionalities.
Overall, over 1000 processes were tested.

3. Configuration Design Documentation and Optimization

We developed 81 detailed configuration design documents outlining the system’s setup and configurations. Also, we reviewed and refined documents to provide clarity, conciseness, and alignment with best practices.

4. Technical Design Specifications and Optimization

Our team created 284 detailed technical design specifications describing the system’s architecture, components, and technical requirements. On top of that, we reviewed and refined existing specifications to improve clarity and technical accuracy.

5. Functional Design Specifications and Optimization

We developed 200 functional design specifications detailing the system’s functionalities and user interactions. Then, we reviewed and refined existing specifications to enhance usability and alignment with business requirements.

6. Documentation Review and Approval

A thorough review of all documentation was conducted to ensure accuracy, completeness, and alignment with project goals. We obtained all necessary approvals from key stakeholders to finalize the documents.

7. Final Validation and Sign-Off

At the end of the project, we performed a final validation of the Global ERP system to confirm it met all requirements and specifications. We also obtained sign-off from key stakeholders, which indicated a successful completion of the validation package development.
The successful completion of this project marks a significant milestone in the optimization of the Global ERP system. Each phase was crucial in ensuring the system’s reliability, performance, and alignment with best practices.

Results

In partnership with DIGIT, the client achieved a validated, reliable, and optimized Global ERP system within budget and on schedule. Our structured approach was key to the project’s success:
  • We evaluated the existing ERP system and identified gaps. There were additional challenges with county-specific requirements and regional compliance.
  • We implemented a comprehensive validation package with rigorous testing. This included verifying systems integrations for real-time data accuracy.
  • We provided detailed user manuals, technical documentation, and compliance reports. Thus the client could understand the system’s capabilities and use its full potential.
The new SAP Validation Package still provides 360 compliance and performance of the ERP system. It helps accomplish the client’s annual strategic goals.
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