Microsoft Dynamics 365 
Finance & Operations 
Software Validation

In highly regulated industries such as medical technology, pharmaceuticals and pharmaceutical chemistry, software validation is an indispensable process. IT managers are faced with the challenge of ensuring that their systems comply with strict regulations and at the same time work efficiently and reliably. Patient safety, product quality and data integrity always play a central role. In this blog article, we highlight the most important aspects of Microsoft Dynamics 365 software validation and show you how Sycor can support you as a reliable partner.

What is software validation?

Software validation is the documented proof that a software system does what is expected of it in a reliable and compliant manner. This is based on the guidelines for “good working practice” (GxP). The validation process covers the entire life cycle of a system - from selection, installation and customizing through to change management, revalidation and decommissioning. The industry standard GAMP 5 (Good Automated Manufacturing Practice) is often used.

Why is software validation important?

In regulated industries, companies are required by law to use validated systems to:

• Ensure compliance with regulatory requirements,
• Ensure patient safety,
• Ensure product quality and
• protect data integrity.

A validated system minimizes risks such as data loss or process errors and ensures smooth operation.

Regulations and standards

Software validation is prescribed by various regulations and standards:

• MDR (Medical Device Regulation)
• FDA CFR Title 21 Part 11 & Part 820
• DIN EN ISO 13485:2016
• In-vitro diagnostics regulation (IVDR)
• GAMP 5 Guideline

Microsoft Dynamics 365 Finance & Operations meets these requirements thanks to its flexible cloud infrastructure and automated testing tools such as RSAT (Regression Suite Automation Tool).

The validation process - step by step

A structured validation process includes:

1. Validation plan: Definition of activities, responsibilities and timelines.
2. User requirements (URS): Documentation of the requirements for the system.
3. Functional specifications: Comparison of the requirements with system functions.
4. Risk analysis: Identification of potential risks.
5. Tests: IQ (installation qualification), OQ (functional qualification), PQ (performance qualification).
6. System operation: Definition of processes for incident management and change control.
7. Validation report: Summary of the results to assess the system status.

Qualification of the Azure Cloud

The qualification of the Azure Cloud is an essential step before the actual validation of Microsoft Dynamics 365 Finance & Operations (D365 FO). This ensures that the cloud infrastructure can be operated in a reliable and auditable manner - taking into account standards such as ISO 27001 and GxP.

Sycor as your partner

As an IT service provider, Sycor supports you at every step of the validation process:

• Planning according to GAMP 5 guidelines,
• Provision of ready-made sample documentation,
• Automated tests with RSAT,
• Training for your employees,
• Support for audits by authorities.

With our expertise in regulated industries, we minimize risks and ensure that your systems function reliably and are audit-proof.

Conclusion

Validating Microsoft Dynamics 365 Finance & Operations is a complex process - but with an experienced partner like Sycor, it becomes much easier. We are with you every step of the way and ensure that your systems meet the highest standards. Rely on our experience in life sciences and medical technology!