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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Webinar: Globale UDI-Anforderungen mit der richtigen Strategie umsetzen (German)

Medical device manufacturers around the globe are facing the challenge of meeting various UDI requirements in several markets worldwide in order to be able to distribute their products in the respective markets. As part of the Life Sciences Alliance webinar

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p36 is ISO 9001:2015 certified

We are proud to announce that we have received ISO 9001:2015 certification for our quality management system at p36. Ensuring that our customers receive consistently high quality products and services is a top priority for us. For this reason, we

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p36 wishes Merry Christmas!

We are looking back on an exciting year 2021 full of changes, which has shown us once again how important authenticity, attention, trust and passion are – values that we at p36 attach great importance to and that are strongly

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UDI Platform by p36 GmbH Achieves SAP® Certification as Built on SAP Business Technology Platform

PRESS RELEASE Bad Hersfeld – November 25, 2021 p36 GmbH announced today that its Unique Device Identifier (UDI) Platform version 2.5 has achieved SAP® certification as built on SAP Business Technology Platform (SAP BTP), SAP’s unified, business-centric platform for the

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Regulatory Update 11/2021

Dear reader, Keeping you up to date with regulatory changes around the world to enable you to prepare your UDI data as soon as possible to comply with regulations is very important to us. With this newsletter, we would like

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p36 macht sich fit für einen guten Zweck

Im Sommer wurden Teile Deutschlands und Europas von schweren Hochwassern heimgesucht. Im Juli hatten extreme Starkregenfälle für massive Überschwemmungen von Flüssen in Nordrhein-Westfalen und Rheinland-Pfalz sowie Bayern gesorgt und dadurch schwere Schäden angerichtet. Viele Hilfen und Spenden erreichten die betroffenen

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Release 2.6 of UDI Platform available now

In September we informed you about our upcoming release of the UDI Platform. We are pleased to announce that our latest release 2.6 of the UDI Platform is now available! As usual, we would like to give you detailed information

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p36 ist erneut Sponsor des 22. Bad Hersfelder Lollslaufs 2021 (German)

Der Oktober steht kurz bevor und damit ist es wieder einmal Zeit für den Bad Hersfelder Lollslauf! Normalerweise läutet der Lollslauf das alljährlich stattfindende Lullusfest ein, das Mitte Oktober auf dem Marktplatz in Bad Hersfeld gefeiert wird. Obwohl das Fest

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SAP Certification of UDI Platform 2.5

As part of our high quality standards, we have ourselves audited annually by SAP to demonstrate the compliance of our UDI Platform with SAP certification procedures. This time, our current UDI Platform Release 2.5 was audited and we are pleased

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Getting to know the Data Elements Explorer

Visualize and compare complex data models at once – with the Data Elements Explorer Due to the increasing UDI requirements in different markets, product registration for medical devices is becoming significantly more complex. Part of our daily work at p36

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Go-Live of UDI Platform at RAUMEDIC AG

In April, we informed about the provision of the UDI Platform for the RAUMEDIC Group to prepare for the EU MDR. At this time, the project team was working on the configuration of the target workflows, data models and user

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UDI Platform Release 2.5 is available

The UDI world keeps turning and our customers have to deal with different topics in the field of medical devices. This requires a UDI Platform that is able to handle these different demands, in order to register relevant medical devices

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Regulatory Update 06/2021

Dear reader, the UDI world is spinning around and along with it more and more regulatory agencies are coming along with their own requirements for UDI compliance. Certainly, you monitor the news about the requirements that are placed on you

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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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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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Get a first impression

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

Request Audit Report

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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