SAP Computer System Validation & Harmonization
Case Study




Since Kymanox’s founding in 2004, we have been supporting projects to help clients be more compliant in their development and manufacturing operations. Not surprisingly, some projects become part of the company’s ethos, exemplifying who we are and the difference we provide. This case study on SAP Computer System Validation (CSV) is one of those projects given the scope and system complexity plus the innovation required.

If you want to learn more about implementing a comprehensive Computer System Validation (CSV) program, contact us today!

CSV Campaign
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SAP Computer System Validation & Harmonization
Case Study




Since Kymanox’s founding in 2004, we have been supporting projects to help clients be more compliant in their development and manufacturing operations. Not surprisingly, some projects become part of the company’s ethos, exemplifying who we are and the difference we provide. This case study on SAP Computer System Validation (CSV) is one of those projects given the scope and system complexity plus the innovation required.

Scenario


A Fortune 200 Life Science Organization partnered with Kymanox to create a full SAP Computer System Validation that needed to incorporate the following:

  • Alignment with Annex 11 and GMP standards for the International SAP Environment
  • Assessment of Complexities from Legacy Systems and Data
  • Retainment of Legacy Custom SAP functionality
  • Development of New Functions, as needed
  • Harmonization with the client’s overall Global SAP Implementation Plan including disparate international sites, systems, and unique data elements.

The Objective


The primary objective for Kymanox was to validate all required CGMP areas of SAP for a multi-country, multi-site roll out. Using our prior knowledge of CSV, we recommended the following steps:

    1. Leverage existing infrastructure — learnings and core documentation — prior to cutover in the main instance of SAP.
    2. Make an efficient risk mitigation inventory to validate legacy data from disparate systems in order to produce a comprehensive Gap Assessment and complete validation.
    3. Copy new validated system without disruption or rework.

The Challenge


The challenge with this particular project was that the client needed to convert six separate SAP instances into one GAMP 5 multi-country, multi-site, validated system with no disruption to on-going enterprise and with an aggressive timeline and cost allowances. The project also needed to be accomplished in alignment with the SAP International vision and thus harmonized into a single global instance.

The major compliance challenges which Kymanox was engaged to address as a priority included:

    1. A significant number of legacy custom objects that were destined to be rolled out with the new system had not been previously validated.
    2. These legacy custom objects were not identified and were not documented.
    3. The client did not know which legacy custom objects were CGxP and which were not.

The Approach


The approach used was the approach that is the cornerstone of our success — a Risk-Based and Process Focused Methodology. A Risk Assessment document was created to assess the risk of the legacy custom objects used in the business process and to develop a mitigation strategy for each of them. However, this project entailed a unique twist. The client did not know the identity of legacy objects, and there were no specifications upon which to base the assessment.

We need to develop a cost-effective, time-effective, and compliant solution to an otherwise show stopping dilemma. In this instance, Kymanox created a custom tool to identify the legacy custom objects in the existing SAP system using, as a basis, the SAP transactions that were documented as part of the business process. The tool generated specification documentation for each object with sufficient information to allow Kymanox to assess the risk and determine an appropriate mitigation. The results from the custom tool were also leveraged to create CGxP compliant content for the specification documents, the risk assessment document, and the testing protocols.

The Results


Kymanox delivered final reports, validated the legacy portion of the new SAP system within budget, and kept the SAP implementation on schedule which was in danger of being derailed. The project’s results demonstrated the value of the Kymanox approach and expertise:

  • Kymanox - Risk-Based and Process-Focused approach
    • Proactive early phase risk mitigation
    • Improved project delivery time and reduced implementation cost

  • Efficient collaboration with client and 3rd party teams on complex SAP Multi-Country SAP Global Roll Out & Annex 11 Validation Effort

  • Kymanox Subject Matter Expertise coupled with rapid custom solutions development exceeded client expectations.

Results

The Results


Results
Kymanox delivered final reports, validated the legacy portion of the new SAP system within budget, and kept the SAP implementation on schedule which was in danger of being derailed. The project’s results demonstrated the value of the Kymanox approach and expertise:

  • Kymanox - Risk-Based and Process-Focused approach
    • Proactive early phase risk mitigation
    • Improved project delivery time and reduced implementation cost

  • Efficient collaboration with client and 3rd party teams on complex SAP Multi-Country SAP Global Roll Out & Annex 11 Validation Effort

  • Kymanox Subject Matter Expertise coupled with rapid custom solutions development exceeded client expectations.
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"This project is a shining, landmark example of how Kymanox uniquely delivers value to our clients. Our team and our methodologies solve new problems in creative ways while also following a logic and documentation pathway that honors all quality and compliance requirements."
According to Stephen M. Perry, CEO and Founder of Kymanox,
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"This project is a shining, landmark example of how Kymanox uniquely delivers value to our clients. Our team and our methodologies solve new problems in creative ways while also following a logic and documentation pathway that honors all quality and compliance requirements."
According to Stephen M. Perry, CEO and Founder of Kymanox,
If you want to learn more about implementing a comprehensive Computer System Validation (CSV) program, contact us today!

CSV Campaign
We collect, use, and process your data according to our Privacy Policy. By submitting this form, you also agree to subscribe to receive emails with thought leadership, news, and tips from Kymanox. *