UDI Compliance (Audit-Trail & Compliant Software)
The implementation of the UDI system worldwide poses a challenge for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted and the path to compliance is extremely complex. UDI requirements vary from authority to authority, presenting a continuous challenge for companies.
To become and remain UDI-compliant, investments in new technologies and software solutions are indispensable. A crucial element is Computer System Validation (CSV), especially in the context of audit trails.
An audit trail, or traceability, is critical for data security and compliance in modern software applications. It meticulously logs user activities and contributes to security, compliance, troubleshooting, and transparency.
Europe IT Consulting GmbH has prepared an in-depth article for you, providing all the essential information to learn more about UDI audit and UDI validation.
Here is the article:
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