Regulatory
environment
We offer a fully validatable ERP system and also support oxaion users in the medical technology sector in planning and implementing an efficient strategy for computer system validation.
Like other customers (our ERP references), you benefit not only from our extensive ERP experience, but also from our special
Expertise in the structures, requirements, and processes of your industry, which we have acquired through projects in the medical technology sector.
Take advantage of this potential for your validation!
Successful
validation with oxaion
We ensure that CSV is supported for the system.
Our ERP system not only allows you to optimally implement your industry-specific business processes—it has also been expanded to include Computer System Validation (CSV) requirements.
If you choose oxaion's ERP software, we will of course ensure that CSV is supported for the system during implementation.
In a workshop, we will work with you to develop the right validation strategy for your company, create a validation master plan (if one does not already exist), and compile an inventory overview of all IT systems. We will then provide support in reviewing requirements and functional specifications, risk analysis, and the test strategy. We are also happy to advise you on the creation of the traceability matrix and the final validation report, as well as on the correct approach to change management.
CSV fitness for older versions and more.
Are you already working with an earlier version of oxaion and need to make your ERP software CSV-compatible? In this case, we will guide you through the release change and support you in choosing the right validation strategy. Beyond oxaion, we are also happy to help you prepare all affected systems and applications at your site for CSV. In this case, our partner, a consulting firm specializing in CSV in regulated industries, will examine your circumstances in an on-site workshop, focusing on the following aspects:
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Analysis of the current situation (QMS review, IT organization)
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Roles and responsibilities (system/process owners, QA, etc.)
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Validation strategy
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Operational processes (authorizations, changes, backup, problem areas)
Based on this, the concept for the Validation Master Plan (VMP) is developed, along with a complete inventory of all validation-relevant systems.
Computer system validation is inevitable – but with us, it becomes manageable for you quickly. Take advantage of our services and experience in the field of ERP software for medical technology and contact us today!
