MASTER DATA MANAGEMENT FOR UDI COMPLIANCE
SINGLE SOURCE CLOUD BASED UDI SOLUTION
- Built in online label designer with GS1 certified barcodes
- GUDID data validation check & SPL generator for submissions
- Work order module to produce labels from all packaging levels
- Data import feature facilitating imports from any system
- Part 11 fully compliant system
Kodit UDID (kUDID) is a cloud based unique device identification (UDI) compliance software solution.
kUDID has been specifically designed to address the requirements of the FDA’s UDI compliance regulations for both labelling and GUDID submission of product data so our customers can be confident they have everything they need to be compliant.
DESIGN YOUR LABELS IN kUDID!
One of the major challenges of UDI is being faced by labellers. With product data being spread across multiple systems or label design software being a separate system, producing labels has become complex and time consuming.
koditPaperFlex (kPF) has been designed to combat these issues by linking both your device information and your work order product data to your label template making label production quick and easy giving you the peace of mind that your label data is accurate. Using kPF’s customised items on your label will also drastically reduce the number of master templates you need.
GET YOUR DATA READY TO SUBMIT
Gathering your data together to submit to the FDA can be an arduous task and mistakes in submissions can be costly.
kUDID facilitates this task by allowing you to import your data into kUDID in stages. It has review and approve work flows to verify the integrity of the data and you can then run a validation check to confirm no information is missing. Once your data is validated kUDID will package the data in the format the FDA requires for submissions making a complex procedure simple.
CREATE WORK ORDERS!
Once you’ve designed your label templates and gathered your product information kUDID’s work order module gives you everything you need to produce your labels to GS1 certified standards.
Choose the information you want encoded in the barcode, preview your label and then print serialised or non serialised labels from within the system or if you prefer you can download to a PDF or ZPL file format.
PART 11 COMPLIANT
Electronic records replacing paper records in the medical device industry has led to added regulations you must comply with. The FDA require that all medical device companies using computer systems must be Title 21 CFR Part 11 compliant.
With kUDID you can relax and be safe in the knowledge that your system is Part 11 compliant with its comprehensive audit history, electronic signatures, fully validated system, review and approve processes and archiving of records.
ONE STOP SOLUTION TO UDI COMPLIANCE
kUDID gives you everything you need to manage your medical device product data and achieve FDA UDI compliance all in one system. It includes a powerful and dynamic online label designer with GS1 compliant barcodes and allows you to create work orders linked to the label designer and your product data
You can run a GUDID validation check and once validated, package your data in the correct format for submitting to the FDA as well as giving you full Part 11 compliance.
CLOUD BASED LABEL DESIGNER
Design labels anywhere in the world with kUDID’s built in cloud based label designer koditPaperFlex (kPF). kPF has been purposely designed to link your label templates to your product data and work orders to give you everything you need to produce your labels.
kUDID has built in checks to guarantee your barcodes will be FDA compliant to GS1 standards and allows you to print your label on any printer. We guarantee you won’t find a better solution for getting your labels compliant.
GUDID VALIDATION CHECK
kUDID contains a validation check on your data to ensure your submissions will be FDA compliant. If your data doesn’t pass the validation stage kUDID will tell you what information is missing and won’t let you create your file for submission until you correct the errors giving you peace of mind that your data will pass the GUDID submission process first time.
IMPORT & EXPORT YOUR DATA
Import your data into kUDID from any of your current systems with our import wizard. If your data is spread across different systems kUDID has an append feature to import it in stages. You can then save your field mapping profiles to make importing and exporting quick and easy.
MANAGE YOUR GUDID SUBMISSIONS
kUDID gives you all the tools you need to manage your submissions to GUDID. It has a validation check, review and approve work flows and produces SPL files, the required file format for GUDID submissions. If you intend to use a third party submitter for your data then the system will create your file with their required data.
Once your data has been sent to the FDA you can see what data has been submitted and where products are in the submission cycle making the process easy to manage.
CONTROL ACCESS PERMISSIONS
kUDID incorporates all aspects of the product data lifecycle so it’s important users of the system can’t access all of it’s features. kUDID allows an administrator to create roles for their users which determine what modules can be accessed but also what functions within that module. Any action of the system can be granted or denied permission so you don’t have to worry about your users compromising the integrity of your data.
MAKE WORK ORDERS FROM YOUR PRODUCTS
kUDID’s work order management module enables you to produce GS1 certified labels using the label templates created in kPF and linked to your product data.
Use our label preview prior to printing so you know exactly what you are printing. If you require serialised labels then just add the first serial number sequence and the quantity of labels and the system will do the rest. You can also select what product information populates both the barcode and human readable barcode string. Once you have everything you need for your labels you can print directly from kUDID to any printer or produce a label in PDF or ZPL file formats.
Prices start from $4950
Unlimited Product Data
Unlimited Label Templates
Unlimited SPL’s Generated
Unlimited Work Orders