Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

Kymanox Validation

by Brian Freymann, Director, Enterprise Solutions

The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title 21 CFR Part 11 and EMA’s Annex 11 require data integrity of electronic records, electronic signatures, and also electronic copies of electronic records throughout the system/process/product lifecycle.

The best-in-practice approach for a life science enterprise solution is a risk-based strategy and tactical application. Whether the system is an ERP or peripheral system, teams should effectively identify and manage the critical data and processes that impact patient safety. Both the FDA and EMA reinforce this view noting the following:




The level of software validation a business is required to perform should be applied in direct proportion to the potential of risk to patient.




The patient-centric, Risk-Based and Business Process-Focused approach is the fundamental element to a compliant solution but may require additional refinement when considering scope. This refinement is especially true against the framework of a multi-process enterprise software implementation in Life Sciences. Without proper application of the fundamentals, scope can become too broad and devolve into a “validate everything” scenario, impacting time and budget.

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. *

by Brian Freymann, Director, Enterprise Solutions

The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title 21 CFR Part 11 and EMA’s Annex 11 require data integrity of electronic records, electronic signatures, and also electronic copies of electronic records throughout the system/process/product lifecycle.

The best-in-practice approach for a life science enterprise solution is a risk-based strategy and tactical application. Whether the system is an ERP or peripheral system, teams should effectively identify and manage the critical data and processes that impact patient safety. Both the FDA and EMA reinforce this view noting the following:

Taking a Risk-Based and Business Process-Focused approach inventory will identify only those processes that have the greatest impact on patient safety and, subsequently, are the most critical to test and validate.


A thorough process inventory removes ambiguity and proactively manages scope by highlighting high risk processes and critical touchpoints.



Overall, this approach improves implementation times, liberates client teams from non-productive tasks, and produces a leverageable validated framework for future software upgrades.




The Kymanox Intelligent Enterprise Compliance Solutions Team is an international provider of FDA-EMA compliant, SAP/ERP, and peripheral software application solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach that is balanced with both regulatory requirements and business needs to ensure tactical efficiency, audit confidence and scalable strategies for software migrations or upgrades.

Get More Done.

To learn how the Kymanox Intelligent Enterprise Compliance Solutions Team can help you ensure tactical efficiency, audit confidence and scalable strategies for software migrations or upgrades, contact Brian Freymann at 305-775-7564 or by email to erp@kymanox.com.



The level of software validation a business is required to perform should be applied in direct proportion to the potential of risk to patient.



The patient-centric, Risk-Based and Business Process-Focused approach is the fundamental element to a compliant solution but may require additional refinement when considering scope. This refinement is especially true against the framework of a multi-process enterprise software implementation in Life Sciences. Without proper application of the fundamentals, scope can become too broad and devolve into a “validate everything” scenario, impacting time and budget.

Taking a Risk-Based and Business Process-Focused approach inventory will identify only those processes that have the greatest impact on patient safety and, subsequently, are the most critical to test and validate.



A thorough process inventory removes ambiguity and proactively manages scope by highlighting high risk processes and critical touchpoints.



Overall, this approach improves implementation times, liberates client teams from non-productive tasks, and produces a leverageable validated framework for future software upgrades.




The Kymanox Intelligent Enterprise Compliance Solutions Team is an international provider of FDA-EMA compliant, SAP/ERP, and peripheral software application solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach that is balanced with both regulatory requirements and business needs to ensure tactical efficiency, audit confidence and scalable strategies for software migrations or upgrades.


Get More Done.

To learn how the Kymanox Intelligent Enterprise Compliance Solutions Team can help you ensure tactical efficiency, audit confidence and scalable strategies for software migrations or upgrades, contact Brian Freymann at 305-775-7564 or by email to erp@kymanox.com.

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. *