SAP Cloud based Life Sciences Solutions

Benefit from agile Cloud Solutions with high Quality Focus

Achieve UDI Compliance with the UDI Platform of p36.labs

Natively built on SAP Cloud Platform

Native SAP Integration

Benefit from native Process Integration into your hybrid SAP Landscape

Who we are

What we do

Focus on Quality

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p36 GmbH named a Finalist for SAP Pinnacle Awards 2021

PRESS RELEASE Bad Hersfeld – May 18, 2021 p36 GmbH today announced that it has been recognized by SAP as a finalist for a 2021 SAP® Pinnacle Award in the Partner Application of the Year – Industry Cloud category. The

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Webinar: Die richtige Strategie und Software für globale UDI-Anforderungen (German)

Am 06. Mai 2021 findet unser nächstes Webinar gemeinsam mit unserem Partner DHC statt. Von 10:00 bis 10:45 Uhr wird Patrick Pfau, Geschäftsführer von p36, darüber sprechen, wie sich Medizinproduktehersteller strategisch am sinnvollsten auf die steigenden globalen UDI-Anforderungen vorbereiten und

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p36 GmbH provides UDI Platform for RAUMEDIC to prepare for EU MDR

PRESS RELEASE Bad Hersfeld – April 7, 2021 The RAUMEDIC Group has been manufacturing medical quality products made of thermoplastic polymers and silicones for more than 70 years with about 900 employees worldwide. RAUMEDIC is currently preparing for the upcoming

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UDI Platform Release 2.4 available now!

We are constantly developing our UDI Platform to support our customer´s global UDI journey. Now we released the latest version 2.4, bringing some great new features that support the daily work with UDI Compliance processes. The enhancement of the custom

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p36 becomes a certified atrify Partner

We proudly announce that we at p36 successfully passed the certification process by atrify and are now a certified atrify partner. This enables our customers to send data through a direct connection from our UDI Platform to the GDSN-certified data

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EUDAMED UDI / device registration module postponed to September 2021

Last week the EC announced on their website that the availability of the MVP (Minimum Viable Product) version of the UDI / device registration module is now planned for September 2021 instead of May 2021. This also applies to the

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Project Insights: Implementation of FDA GUDID Content Package including migration

In October 2019, we announced the start of our first EUDAMED project for UDI Platform with a world-leading medical device manufacturer. Meanwhile, the project has been finalized and our customer is ready to submit product master data to the EUDAMED

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Welcome to our team, Marcel!

As already announced, 2021 brings some positive changes for p36. This also includes the expansion of our team. We are very happy to welcome Marcel Jünge as our newest team member. Based on his previous experience, he joined p36 as

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projektraum36 GmbH & Co. KG has become p36 GmbH

Bad Hersfeld, January 14, 2021 projektraum36 GmbH & Co. KG was founded in 2015 in Bad Hersfeld by two enthusiastic SAP specialists, Patrick Pfau and Robin Wennemuth. Since then, the company has constantly developed and expanded its portfolio. In addition

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Gemeinsame Info-Session mit atrify und GS1 Germany (German)

Viele Unternehmen aus der Industrie beschäftigen sich derzeit mit der Frage, wie sie die steigenden Anforderungen bezüglich Stammdaten und UDI meistern können. Im Rahmen einer einstündigen Live Session am 04. Februar 2021 sprechen Sylvia Reingardt von GS1 Germany , Stefan Domdey

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p36 wishes you a Merry Christmas

The Corona pandemic has had a major impact on the professional and private lives of all of us this year. We are all the more grateful that our thoughtful approach has enabled us to successfully secure the ongoing operations at

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Introducing our strategic partnership with QUNIQUE

We are pleased to officially announce our strategic partnership with QUNIQUE, a consultancy organization from Switzerland which is specialized in developing tailored concepts and solutions to support, maintain and improve the compliance of companies in the medical, in-vitro diagnostic and

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p36 meets SAP TechEd on December 8 – 10, 2020

From December 8th – 10th, 2020 SAP’s premier technology education event TechEd will take place, showcasing the latest tools and technologies in and around the SAP ecosystem. In recent years, TechEd took place at different locations around the world, but

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Welcome to our team, Simone!

p36 is still growing and expanding to support our customers in the Life Sciences with their strategic UDI-setup. We are very excited to welcome our new team member Simone Rennack, who joined our team as Professional Consultant and Project Manager on

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UDI Platform 2.3 release

The newest release of our UDI Platform to version 2.3 is available and adds new features helping medical device companies implementing and living their global UDI strategy. The following features are new: We enhanced the business process capabilities by offering manual

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Our Partners

Achieve UDI Compliance with the UDI Platform of p36.labs

Natively built on SAP Cloud Platform

Topics Modul

The UDI Challenge

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.

SAP Integration

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.

Solution

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.

Validation

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.

Learn more

The global UDI Challenge

Really try to do it on your own?
7 reasons for a cloud-based and SAP integrated approach

  • Concentrate on your Core Business

    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.

  • Native SAP Integration

    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.

  • Less Support effort

    An externally managed Cloud solution delivers required Updates and includes Support, thus relieving the burden from your Support Organization.

  • Simplified Ressource Planning

    A managed Cloud Solution scales for you with every Regulatory Authority. You neither need new hardware nor Software Development Ressources.

  • Clear Test and Change Management

    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.

  • Calculable Costs

    A Cloud Provider offers transparent licensing metrics for the Service Subscription. You achieve Planning security on your whole UDI Lifecycle.

  • Compliance

    A managed Solution covers all requirements on the submission handling to UDI Databases worldwide – stay compliant with a validatable Solution.

Get support from our UDI Experts!

Would you like to learn more about UDI from our UDI team? Please drop us a message and we will reach out to you!

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See more in our Product Demo

Most of your UDI Data is maintained in your ERP already?

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.

  • Validation of your data
  • Simplified Release-Workflow
  • Submission Management
News

Device Data is ready, but Agency-specifics missing?

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.

  • Data enrichment
  • Validation of your data
  • Customized Release-Workflow
  • Submission Management
Imprint

Most of your UDI Data shall be managed in a new UDI Solution?

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.

  • Create new maintenance flows
  • Data enrichment
  • Validation of your data
  • Customized Release-Workflow
  • Submission Management
Knowledge base

Integration Options

It’s your choice: We provide various Integration Options based on SAP Technology. It depends decisive on your current Landscape which Technology is the right one for your Company.  Reach out to us if you would like to know more about your possible Integration Scenario.

SAP ERP S/4 HANA On-Premise S/4 HANA Cloud Other systems
REST
ODATA / CDS
ODATA
SAP SLT *
SAP SDI *
SAP PI *
SAP CPI *
* SLT = SAP Landscape Transformation | SDI = Smart Data Integration | PI = Process Integration | CPI = Cloud Process Integration | Separate licenses needed

Validation Partner

Chemgineering is your partner for compliance topics. As experts for validation and qualification Chemgineering supports your way to the Cloud.

Statement COVID-19

Validation Package

Chemgineering 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:

  • Introduce and operate the UDI Platform Solution in accordance to the regulatory requirements in Europe and overseas
  • Auditing and audit-proof operating the UDI Platform Solution
  • Pre-built Life-Cycle Documents

The Life-Cycle Documents include:

  • URS-Template
  • Validation-Plan (VP)
  • Risk-Analysis  (RA)
  • Trace-Matrix (TMX)
  • Test-Templates for IQ / OQ and Acceptance tests (PQ)
  • Pre-built final reports for IQ / OQ and PQ
  • Pre-built Validation Report (VR)
  • Examples for User-SOPs (e.g. Administration, Change-Control, Data security, Disaster-Recovery, SLA-Monitoring)

Supplier Audit

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Supplier Audit

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See our webinars

Read our Whitepapers and Presentations

UDI Platform Factsheet

Achieve UDI compliance - with the UDI Platform by p36.labs

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UDI Platform Overview presentation

UDI Platform - a managed service on SAP Cloud Platform

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Unique Device Identification for Medical Devices

Effizient Handeln: Mit passender UDI-Strategie und cloudbasiertem Ansatz

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Patrick Pfau Founder

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Patrick Pfau Marketing Manager

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Robin Wennemuth Founder

Analytisch, empathisch, lösungsorientiert, engagiert, humorvoll, lauf- und technikbegeistert – und als Berater in erster Linie Lösungsfinder.

Patrick Pfau Founder

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Patrick Pfau Marketing Manager

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

Patrick Pfau Founder

Querdenker, Visionär, Tekkie, Familienmensch – immer auf der Suche nach neuen Herausforderungen. erfahren Sie mehr über Patrick

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