p36.labs is a Business Unit of projektraum36, a SAP Silver Partner focusing on SAP Cloud Platform Solutions.
We have a strong Background in Unique Device Identification (UDI) Topics since 2012, including Consultancy and Project Management for several Med Tech Companies in this area.
p36.labs focuses on Product Solutions and Consulting for the SAP Cloud Platform.
We build and run Cloud based Solutions for the Life Science Industry with Focus on native SAP Integration. With our UDI Platform, we provide a Managed Service for UDI Data Maintenance and Submission Management for the Medical Device Industry on the SAP Cloud Platform.
High Quality is our clear Focus in Company Processes and our Product Development Lifecycle.
p36.labs is working in accordance to GAMP® 5 requirements in its Software Development Lifecycle covering all necessary Deliverables.
Our Product Solutions are designed to meet the specific requirements of the regulated Industry, compliant to 21 CFR Part 11. You can expect a complete Audit Trail in our applications by design in order to provide optimal support for your Software Validation.
projektraum36 as Company behind p36.labs recently passed a formal Supplier Audit for its UDI Platform Solution. The corresponding Audit Report is available for interested Customers on request. A formal ISO 9001:2015 Certification for our Quality Management System is planned for the near future.
Software Solutions in the regulated Life Sciences Industry must be validated. In order to support the Validation we collaborate with our Partner chemgineering Business Design, offering a preconfigured Validation Package for increased time-to-value for your operations. 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.
With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.
The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.
„Recommended by SAP for fast UDI Compliance“
The Medical Device Regulation (MDR) in the EU becomes effective in May 2020 and draws attention to Unique Device Identification (UDI). Anyway, UDI is a global Challenge.
Benefit from a native Process Integration into your hybrid SAP Landscape. We support various technologies to seamlessly integrate our SAP Cloud Platform based UDI Platform with your on Premise or Cloud SAP Systems.
Our UDI Platform is delivered with preconfigured Content Packages specific for the UDI Databases of different Regulatory Agencies. Use it out-of-the-box as a managed Cloud Solution.
Cloud based solutions need an adapted approach for Computer System Validation (CSV). Learn, how our Validation Partner Chemgineering supports you in validated and qualified operations of the UDI Platform Solution.
Manufacturers of Medical Devices must take action now in order to submit their Product Master Data to Unique Device Identification (UDI) Databases worldwide.
After the US Food and Drug Administration (FDA) the EU will follow with its Medical Device Regulation (MDR), becoming effective in May 2020 – it´s only a few months to go! Many countries more – e.g. China, India and Korea – are to follow, so it´s time for a strategic setup for UDI. Medical Device Manufacturers will need a Software Solution for Maintenance, Validation and Submission of UDI related Product Master Data, handling various different Data Models of different Regulatory Authorities with their Validation Rules, different Data Formats and Submission Handlings.
The requirements affecting your UDI Processes are driven by external Regulatory Authorities. A Cloud Service Provider is close to the market and implements upcoming requirements timely.
A SAP Cloud Platform based Solution natively integrates with your existing SAP System Landscape. Leverage your existing Product Master Data in your SAP ERP Systems based on Standard Interfaces and optimize your Data Quality using flexible Approval processes.
An externally managed Cloud solution delivers required Updates and includes Support, thus relieving the burden from your Support Organization.
A managed Cloud Solution scales for you with every Regulatory Authority. You neither need new hardware nor Software Development Ressources.
A managed Solution ensures the majority of tests during Changes of the UDI Process. A clear Change Request Handling and traceability ease to estimate the Regression Test efforts for your Validation.
A Cloud Provider offers transparent licensing metrics for the Service Subscription. You achieve Planning security on your whole UDI Lifecycle.
A managed Solution covers all requirements on the submission handling to UDI Databases worldwide – stay compliant with a validatable Solution.
Would you like to learn more about UDI from our UDI team? Please drop us a message and we will reach out to you!
Request Recall
With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.
The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.
With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.
The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.
With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.
The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.
Chemgineering is your partner for compliance topics. As experts for validation and qualification Chemgineering supports your way to the Cloud.
Statement COVID-19Chemgineering provides a Validation Package for the UDI Platform of p36.labs.
It is based on a CSV approach adapted to the UDI Platform and the specific requirements of the medical device industry to:
projektraum36 as Company behind p36.labs passed a Supplier Audit for its UDI Platform recently. We provide an extract of the Supplier Audit Report on request.
projektraum36 as Company behind p36.labs passed a Supplier Audit for its UDI Platform recently. We provide an extract of the Supplier Audit Report on request.
Achieve UDI compliance - with the UDI Platform by p36.labs
UDI Platform - a managed service on SAP Cloud Platform
Effizient Handeln: Mit passender UDI-Strategie und cloudbasiertem Ansatz
