SOLUTIONS FOR UDI COMPLIANCE
FULL DEPLOYMENT FLEXIBILITY
THE CHALLENGE
The adoption of UDI policies around the world presents a major challenge for global manufacturers trying to understand and comply with this flurry of regulations. In addition, manufacturers are presented with the challenge of submitting UDI data to a myriad of country-specific regulatory agencies, each with their own variant of UDI standards. Failing to achieve compliance will compromise your company’s ability to sell product into each market. Trying to build, configure and maintain individual “connectors” for each country that will support the local attribute definitions, code value lists, and validation rules will be costly and not a scalable solution in the long-term.
THE SOLUTION
Innovit’s UDI Compliance solutions solve these challenges by allowing device manufacturers to implement a “global system and unified process” that is fully integrated with internal systems to submit product data for multiple UDI recipients simultaneously.
Simplify your global UDI strategy by choosing Innovit’s GUDID.cloud and EUDAMED.cloud solutions which provide the tools to assist with data aggregation, maintenance, cleansing, and data validation prior to submission. Leverage a single solution that is scalable globally to other target markets at minimal incremental cost.
Features
- Data Validation delivers trusted, high-quality product data by leveraging Innovit’s built-in data quality and data validation tools. Ensure that product data is accurate and compliant with any pre-defined set of validation rules from each regulatory agency, as well as any internal, user configured data attributes and business rules.
- Innovit solutions ensure device manufacturers are compliant with GAMP 5 standards for system validation.
- Built-in functionality for data versioning and electronic signatures that are compliant with 21 CFR Part 11 requirements (and EU Commission’s Annex 11).
- UDI data submission capabilities for regulators to ensure regulatory data is accurate and that the process is scalable for data compliance across all markets.
- Ease of enabling new countries at a fraction of the cost of alternatives such as data submission services or standalone country-level compliance solutions.
Benefits
- Minimize your IT ownership costs by simplifying your regulatory compliance landscape while reducing cost of change management – end-user support, staff training, process documentation and system validation.
- Pre-configured, out-of-the-box attributes, data validations, code values, and approval workflows that help with managing, validating and submitting regulatory data to the FDA and EU Commission.
- Seamless user experience that captures the SRNs (Single Registration Numbers) from your Actor Registration process, Conformity Certificate identifiers from Notified Bodies, and the device data as inputs to the manufacturer’s device registration and UDI submission systems.
INCLUDED SUPPORT SERVICES
Innovit Cloud Hosting comes included with the following support services:
- Immediate telephone access to our Tier II Support Engineers (SEs) during normal business hours for all support-related issues. Even in cases where the issue is not Innovit-related, our SEs will assist you in identifying the cause of the problem and recommend appropriate action for you to take.
- During normal business hours our SEs actively monitor all customer servers and proactively take whatever action is needed to address problems.
- We provide 24/7 standard monitoring of the following:
– HTTP (your Web APP), FTP availability, Ping, TCP Ports, DNS - In the event of a hardware failure either during or outside business hours, we guarantee you – in writing and backed by monetary penalties – a 4-hour maximum fix-time from the time we are alerted to the problem. This is in stark contrast to most other hosting companies who generally will only be prepared to offer you a 4-hour problem response guarantee, with no fix-time guarantee.
- We install, manage and update on-server antivirus software
- We take responsibility for all patching and updating of the system software (the OS, IIS, and SQL)
- We apply patches on a regular basis and monitor the system to ensure that patches are applied successfully
- We provide on-server monitoring of CPU, RAM, and hard disk utilization and send you notifications whenever these resources are
being constrained