UDI is not a one-time task, it is going to be an ongoing Process in your Company. In future, more Regulatory Authorities are to come – and you will have to handle the upcoming changes of requirements of the existing UDI Databases. Just introducing a new Software will not be enough – that´s why we take advantage of the capabilities a cloud-based Software application provides.
Together with our Partners we monitor the Market requirements and take action if new requirements arise. Specific changes of existing Authorities are implemented timely to stay compliant in a market and provided into your Cloud Solution Account. New Regulatory Authorities and their UDI Databases are covered by new Content Packages delivered on top of the UDI Platform Core and can be ordered if you operate in the affected market. Together with an active Customer Support this builds the baseline of our Managed Service approach.
Software Solutions in the regulated Life Sciences Industry must be validated. To keep your Software in a validated state, the Validation Package and continuous Validation support by our partner Chemgineering Business Design complements our Portfolio. In order to support the Standard Change Processes, p36.labs delivers its Test Execution results as a base for your own Validation processes, hence enabling a much faster Test of delivered Changes.
* p36.labs plans to offer Content Packages for all UDI Databases worldwide within a reasonable time, if this is not ruled out by regulations of the respective country or region. p36.labs will proactively inform Customer about the upcoming availability of further agencies in its Release Plans.