UDI.cloud for GUDID
From: $150.00 / month with 1 year free trial
Get started today with Innovit’s UDI.cloud for GUDID compliance – the most cost-effective, cloud-native SaaS solution to help you become compliant with the FDA for UDI submissions. Simple prepackaged data validations and data maintenance workflow to help prepare your regulatory data for automated submission to the FDA’s GUDID system.
Introducing GUDID.cloud, your 'UDI.cloud solution for GUDID'!
A modern, SaaS platform designed to make your job easier for UDI data submissions to the FDA. GUDID.cloud is designed as a cloud-native system to help you reduce the effort and knowledge required to prepare, validate and submit your product data for regulatory compliance with the FDA's GUDID system.
KEY BENEFITS:
- Fully hosted in a secure cloud-native environment with ISO 27000 certification.
- Your data is fully backed-up with real-time disaster recovery across multiple geographical locations.
- GAMP5 compliant for system validation with IQ and OQ validation packages included.
- 21 CFR Part 11 compliance with comprehensive data versioning with electronic signatures, and audit trail reporting & logs.
- Pre-packaged with 2-stage or 3-stage workflow for data validation, data maintenance, review & approval before submission.
- Pre-packaged data validations and code lists to reduce the need for expert knowledge for GUDID data preparation and cleansing.
- Automated machine-to-machine (M2M) data submission using HL7 SPL message formats, and acknowledgement message handling.
- 1-click access to your submission status and submission history with full on-screen visibility to all ACK1, ACK2 and ACK3 messages.
- Optional machine-to-machine integration to source systems via web services APIs or batch file interfaces (including CSV, Excel or GS1 XML).
- Self-paced learning with online, audio-visual tutorials to learn the GUDID.cloud system and GUDID data requirements are your own leisure - anytime, anywhere!
- A modern, user-friendly experience (UX) that’s accessible using all major web browsers, and built using state-of-the-art Angular Typescript technology (not outdared JavaScript).
Best of all, you can enjoy the above benefits and capabilities for as little a $150 per month!
Introducing GUDID.cloud, your ‘UDI.cloud solution for GUDID’!
A modern, SaaS platform designed to make your job easier for UDI data submissions to the FDA. GUDID.cloud is designed as a cloud-native system to help you reduce the effort and knowledge required to prepare, validate and submit your product data for regulatory compliance with the FDA’s GUDID system.
KEY BENEFITS:
- Fully hosted in a secure cloud-native environment with ISO 27000 certification.
- Your data is fully backed-up with real-time disaster recovery across multiple geographical locations.
- GAMP5 compliant for system validation with IQ and OQ validation packages included.
- 21 CFR Part 11 compliance with comprehensive data versioning with electronic signatures, and audit trail reporting & logs.
- Pre-packaged with 2-stage or 3-stage workflow for data validation, data maintenance, review & approval before submission.
- Pre-packaged data validations and code lists to reduce the need for expert knowledge for GUDID data preparation and cleansing.
- Automated machine-to-machine (M2M) data submission using HL7 SPL message formats, and acknowledgement message handling.
- 1-click access to your submission status and submission history with full on-screen visibility to all ACK1, ACK2 and ACK3 messages.
- Optional machine-to-machine integration to source systems via web services APIs or batch file interfaces (including CSV, Excel or GS1 XML).
- Self-paced learning with online, audio-visual tutorials to learn the GUDID.cloud system and GUDID data requirements are your own leisure – anytime, anywhere!
- A modern, user-friendly experience (UX) that’s accessible using all major web browsers, and built using state-of-the-art Angular Typescript technology (not outdared JavaScript).
Best of all, you can enjoy the above benefits and capabilities for as little a $150 per month!