Tuesday May 31, 2016

How It Works: Oracle Innovation Management Cloud Demo

Just published! Watch this on-demand demo of Oracle Innovation Management Cloud to see the best practice approach to increase your returns on product and service innovation.   Get a quick "how it works" overview, check out the ideation analytics, watch how to create proposals, view the "what if" scenario KPIs, and much more!  A great way to quickly  beef up on your Innovation Management essentials. More at www.oracle.com/InnovationManagement

Kerrie Jordan is Director, PLM and Innovation Management at Oracle. Follow her @KerJordan and learn more about Oracle's SCM Cloud solutions at www.oracle.com/scm

Tuesday Apr 19, 2016

Essentials of Oracle PLM for Retailers

With new competitors, trends, regulations, business models, markets and technologies, rapid change defines your industry. Disconnected systems cannot support how fast your retail organization needs to anticipate, respond, and adapt to new product-and service-related challenges.

Oracle PLM gives you an integrated innovation platform with the speed, oversight, and control to deliver higher quality products to market sooner. By enabling modern PLM processes for retail, you can achieve faster growth, competitive differentiation, and profitability. 

Here's a quick overview of the Essentials of Oracle PLM for Retailers:

  • Private Label Management
    Managing the innovation and commercialization of your own product lines as a retailer is no easy task. Oracle PLM provides a single version of the truth for product information, giving you greater control over costs, quality, compliance, and efficiency.

  • Menu Management
    Stay ahead of evolving consumer preferences—such as taste, variety, local sourcing, sustainability, and nutrition information—while balancing cost and value. For quick-serve, casual, and fine dining restaurants, a single innovation hub allows you to centralize product and supplier information to efficiently develop new offerings, change menus quickly, experiment with variations, and keep consumers informed.

  • Innovation
    Tap social networks—a primordial soup of ideas—to select the best ones, capture requirements, and funnel the meaning behind all that big data directly to product development. Oracle PLM provides a seamless solution in the cloud to elegantly navigate this massive amount of data to identify and translate the right ideas into profitable products.

  • Artwork and Packaging
    Make sure your product’s packaging is superb. Visualize and collaborate on the artwork, packaging, and labels in a secure, web-based system that’s accessible from anywhere. Oracle PLM simplifies, automates, accelerates, and tracks packaging changes—so that you can reduce time to market, eliminate errors, and control risk.

  • Portfolio Optimization
    Innovate strategically by establishing a systematic approach to manage innovation investments. Optimize your product and service portfolio by balancing sustainable, iterative innovations with bolder, more experimental offerings. Standardize the proposal process and collaborate securely with team members. Model what-if scenarios, analyze each potential innovation investment, and select your optimal go-to-market portfolio.

  • Analytics
    Make more informed product decisions with role-based, actionable insight at any stage of the product lifecycle. Embedded analytics empower decision-makers with relevant information so that they can proactively take steps to improve product performance.

  • Cloud
    Choose the right deployment model that fits your business requirements. Oracle PLM Cloud uniquely offers world-class PLM backed by all the innovations, efficiencies, and cost savings of Oracle Cloud.

    Oracle is committed to providing best-in-class PLM solutions in the right deployment option for your business: PLM on Oracle Cloud, managed cloud, or on premises. Trust Oracle to help transform your product development processes to fit your business needs and ROI expectations.

    Find more details, customer case studies, reports, and brochures on the Oracle PLM for the Retail Industry website.

    Kerrie Jordan is Director, PLM Product Marketing at Oracle. Follow her on Twitter @KerJordan.

Monday Mar 14, 2016

How to Prioritize the Right IT Projects: Bi-Weekly Live Webinars

IT Organizations are under a lot of pressure to get more strategic:

  • 60% of CIOs say they want their IT organizations to focus on assisting in business innovation*

  • 90% of CEOs are promising investors more from technology** but only

  • 20% are satisfied with how quickly their IT departments respond***.

Do your current tools give you transparency with the business to align priorities and focus on higher value projects? Do you have visibility to balance IT portfolio with budgetary constraints?

Please join us for a comprehensive webcast into how Oracle Innovation Management Cloud can give you better visibility into the likelihood of success or failure of a new project and transparency with the business to collaboratively choose the best, high-value projects that are achievable within IT’s budgetary and workload constraints?

See how this solution will help you gain a high value, low risk, best practice approach to very quickly improve IT performance and impact top-line revenue growth.

Please register here for our Innovation Management Webinar “IT Project Prioritization”:

- 5/13/2016@ 12 PM EST

- 5/27/2016 @ 12 PM EST

- 6/10/2016 @ 12 PM EST

- 6/24/2016 @ 12 PM EST 

Please click here to see all available options for the Innovation Management Webcasts

Sources:

* Deloitte 2015 Global CIO Survey

** PwC 19th Annual Global CEO Survey, 2016

*** Harvard Business Review, 2014

Thursday Mar 10, 2016

Select the Best Product Innovations: Bi-Weekly Live Webinars

60-80% of resources are spent on projects that will not meet objectives* – a high cost for companies constrained by resources and budgets that are relying on innovation for growth.

Do your current tools give you visibility to improve success rates and achieve higher return?

Please join us for a comprehensive webcast into how Oracle Innovation Management Cloud can give you better visibility into the likelihood of success or failure of a new product and empower you with the insight to prioritize and invest in the best ideas.

See how this solution will help you gain a high value, low risk, best practice approach to very quickly improve innovation performance and impact top-line revenue growth.

Please register here for the upcoming Innovation Management Webinars “How to Select the Best Product Innovations”

- 5/20/2016 @ 12 PM EST 

- 6/3/2016 @ 12 PM EST

- 6/17/2016 @ 12 PM EST 

- 6/24/2016 @12 PM EST 

 

Please click here to see all available options for the Innovation Management Webcasts

Source: *Harvard Business Review, 2011

Oracle is showcasing its IDMP Enterprise Foundation Suite for Pharma at the Marcus Evans IDMP Compliance Challenge Event in Frankfurt/Germany April 13-15th

Combining a set of industry proven applications to manage x-functional product domains, drug safety and medical dictionaries Oracle offers the most comprehensive solution for pharmaceutical companies to achieve IDMP compliance and beyond – Come and see how in Frankfurt or click IDMP-Info-Request.

Hear Oracle´s Bertrand Godillot and Michael Braun-Boghos talk about “Breaking Down Silos to Enable New Ways of Working while Achieving IDMP Compliance as a Byproduct: - Turn IDMP into an opportunity to reset the industry standard for compliance cost”. In this session, Bertrand Godillot and Michael Braun-Boghos will explain how Oracle’s approach to IDMP compliance differs from other solutions and why it benefits the entire organization including regulatory affairs, product safety, clinical development, and product quality. Based on mature, industry proven applications and technology, the Oracle IDMP Enterprise Foundation Suite is available now to help pharmaceutical manufacturers and sponsors achieve compliance while simultaneously defining a new standard in reducing compliance costs. After compliance is achieved, the Oracle solution allows further benefits to be realized such as process integration, product data governance and big data analytics across applications.

Monday Feb 15, 2016

PLM for IT Service Management helps companies plan and execute the IT Service project portfolio

IT organizations operate at the pinnacle of lean and digitized innovation as employees in nearly every industry are asked to turn innovative thinking into value for customers and the business. IT departments are tasked with meeting the needs of the business while balancing a steady stream of new project requests, such as enhancing enterprise applications, building mobile apps, refreshing websites, upgrading software, develop new IoT based offerings etc. Before choosing where to invest time and resources, IT organizations must decipher both the value of each proposal and the corresponding impact on cost, risk, priority, viability, and resource allocation. Given so many projects already in queue, standards to enforce, constraints to rationalize, requirements to track, and corporate objectives to achieve, how can IT organizations effectively and reliably select the right mix of projects that will create the greatest value?


Oracle Innovation Management Cloud provides IT with a central innovation platform to consolidate, analyze, and select proposals that offer the highest business value within bottom line constraints, and plan the IT Service Portfolio. Companies can work on ideas for IT projects, requirements and functional concepts, and leverage the proposal to portfolio flow to help with the formulation of the IT services.

In addition, Oracle Project Management Cloud can be leveraged to execute the IT Projects, as it supports the agile software development methodology, and provides great features related to project management, with task and resource management.

It is of course possible to leverage only the planning or just the execution side.


IT Service Portfolio Management helps customers systematically turn IT project requests into successful IT projects!

This use case of Innovation Management and Project Management Cloud is of specific relevance in the Service industry, but it is of course very well applicable in the Consumer Goods, HighTech, Industrial Manufacturing, and other industries. To learn more, check out the solution brief here, and ask your Oracle representative.


Tuesday Feb 09, 2016

How to Close the Innovation Gap

When you hear the word “innovation” it is likely that what first comes to mind is a new ground breaking technology. The reality is that there are many types of innovation and the inspiration for those innovations can come from many sources. Incremental innovation, most common, improves a current offering; process innovation improves how you produce or deliver a product; service & business model innovation improves customer interaction & experience; frugal innovation delivers more with less –targeting lower cost offerings typically to emerging markets, and the most publicized type of innovation, radical, breakthrough, disruptive innovation which significantly changes what the market and customer expects.

With so much input, filling the innovation funnel with ideas isn’t a problem for most companies– feeding the funnel with a balanced and steady stream of good ideas that are both achievable AND align with product, business and company strategies presents the greatest challenge. Lacking a collaborative, disciplined, systematic approach to selecting the best ideas that are translated into achievable, profitable offerings continues to challenge even the most notable companies.

Therein lays the greatest challenge to closing the ‘innovation gap’ – the gap that exists between what executives establish as strategy and expect versus what their organizations deliver.

In the following article published by Techzone360, Gayle Hayes, Senior Director of Product Strategy and Julia Vagdati, PLM Product Marketing Lead, discuss the strategies to close the Innovation gap, increase ROI and drive profitable growth in your organization. Click here to read the full article.

Tuesday Feb 02, 2016

Oracle MSCE 2016 Recap

Last week at the San Jose Convention center, we pulled together more than 400 PLM professionals with the Oracle MSCE conference.  The energy and passion for PLM was amazing.  The conference is always a high point in the year where Oracle and our customers can spend time together.  Conversations vary from people just starting their PLM journey to many who have been with Agile PLM for many years. 

For the Agile PLM product, we had 6 great sessions focused on different aspects of Design integration into PLM, also known as Engineering Collaboration (EC).  Three customers, Qualcomm, Specialized, and Pella, spoke about how EC integrations impacted their business.  We also had presentations from Perception on AgileEXPLORER and xPLM on new dynamic document authoring tools.  We also presented on Design File Release with Agile PLM 9.3.5 and EC MCAD 3.5, along with AutoVue for Agile PLM 21.0.0.  For EC devotees, the conversation continued into Thursday with a 3 hour workshop on EC and AutoVue. 

Cloud was another area of significant focus.  Discussion of Cloud included the hybrid cloud model with Cloud Innovation Management (IM) working with Agile PLM, as well as the pure PLM Cloud offering of IM, Product Development, Projects, and Product Hub.  All of our customers are evaluating Cloud opportunities to improve user acceptance of, and to change the financial costs of, enterprise software deployments.  This conference provided a huge opportunity to discover more about the Oracle PLM offering and roadmap to the Cloud.  As Devendra Singh presented in the Cloud Roadmap Session, Oracle is committed to release new versions of Agile PLM for the next many years as the Oracle on premise PLM solution.  Cloud IM already integrates directly to Agile PLM to offer additional use cases that solve deep Product Innovation problems. 

The conference also featured an amazing set of customer speakers in other sessions.  These additional speakers represented Beachbody for PLM for Process, Otterbox, Harris, Ichor Systems, CooperVision, Cisco, ThermoFisher Scientific, NBTY, Dell, and Lilly.  I have worked with many of these customers over the years, sometimes to solve problems, sometimes to plan how to better use PLM.  Over all this time, these customers have partnered with Agile Software and now Oracle to deliver exceptional functionality to their users that delivers significant business value.  Agile PLM and Cloud PLM deliver value by being flexible, modular, and fast.  Our customers implement key processes, build trust and success, then are able to tackle the next problem. 

Thank you to our customers.  Thank you to our partners.  We had a robust partner presence at the conference.  These partners provide amazing rapid value during the different phases of deployments and operation of PLM systems.  Hopefully everyone had a chance to talk to our partners and learn more about what they do to help you deliver value from your PLM systems. 

If you were not able to come this year, I hope you consider coming out next year.  We had workshops on Monday and Thursday.  Partners offered training on Monday.  The MSCE conference now spans 4 days.  If you look at the fees to attend other technology or process conferences, I think you will find that MSCE is extremely cheap to attend.  MSCE gives you and your PLM professionals a huge opportunity to connect and learn.  For those who did attend, please let us know how to get better.  Please fill out the surveys.  We are listening and want to do more.  Presentations from the conference are available on the MSCE 2016 Website.  For our European counterparts, London MSCE is kicking off today.

As a final plug, here is the link to our Agile PLM knowledge blog post: http://bit.ly/knowagileplm.  This post offers links to additional resources and information about TOIs.

Thanks everyone!

Thursday Jan 07, 2016

Agile Product Lifecycle Management 9.3.5 and Oracle Product Lifecycle Analytics 3.5 are available

Agile PLM Logo

We are pleased to announce the general availability of Agile Product Lifecycle Management 9.3.5 and Oracle Product Lifecycle Analytics (OPLA) 3.5 release. Both are now available on the Oracle Software Delivery Cloud website.

Oracle’s Agile Product Lifecycle Management solutions enable businesses to accelerate product innovation and maximize product profitability by managing the information, processes, and decisions about their products throughout the product lifecycle and across the global product network. With a broad suite of enterprise-class product lifecycle management (PLM) applications and time-to­-value-focused implementations, Oracle provides the most comprehensive PLM solution in the industry. We continue to deliver on our Oracle Applications Unlimited commitment to continuously innovate in current applications while also delivering the next generation of Cloud applications.

Agile PLM

Agile PLM 9.3.5 extends the value and flexibility of Agile PLM with the addition of a Multi-Project Gantt, a Gantt editor that supports multi-project program and dynamic portfolio assessment. Additionally we have added single and multi-project Gantt resource risk assessment and custom filtering, as well as other user driven enhancements. In Agile PLM 9.3.5 Engineering Collaboration, we have added a new process, Design Release, that extends the reach and control of Agile workflow management directly to the engineers for the review, markup incorporation, release, and publication of CAD design files into PLM, directly from the CAD client and/or in the Web client. Finally the implementation of AutoVue 21, with Agile PLM 9.3.5, continues to improve performance and extend markup management.

Agile Product Lifecycle Management 9.3.5 is available on Oracle Software Delivery Cloud for download under the respective licensed products. The Agile Product Lifecycle Management Documentation Library Release v9.3.5 (Part Number E69230_01) is available on the OTN. TOIs for Agile PLM 9.3.5 will be available shortly after release on My Oracle Support.  Search in the Knowledge area for Article ID 1962485.1. Also check Support's MOS announcement Now Available: Agile Product Lifecycle Management 9.3.5 (Doc ID 2093968.1). For a more detailed description of the release, refer to the release notes available with the release software and documentation.

Oracle Product Lifecycle Analytics is a comprehensive solution which provides Integrated Performance Management to establish priorities and measure business objectives, Operational Analytics to proactively address issues as they arise and Reporting to provide stakeholders a consistent view of progress - enables companies to develop and launch innovative products that deliver on key performance metrics. With pre-built best practice analytical capabilities, Oracle Product Lifecycle Analytics turns large volumes of product lifecycle data into insights to quickly identify and mitigate product risk, monitor metrics and optimize resources to execute in line with key business objectives.

Oracle Product Lifecycle Analytics 3.5 certifies OPLA with the new capabilities of OBIEE 11.1.1.9,0 extends the operational schema to align with new content added in Agile PLM 9.3.1 to Agile PLM 9.3.5 enabling new analytics such as Intellectual Property Analytics and Time Sheet Analytics, extends OPLA configurator to include Page 2 fields and provides additional performance improvements.

New capabilities of the OPLA 3.5 release includes certification with OBIEE 11.1.1.9.0 which offers several new capabilities, such as Mobile Application Designer, Treemap visualization which is useful when charting percent contribution such as Number of Quality Events based on Failure Modes & Product lines / Change Orders by Product lines and Reason for Change, Search for a column within a Subject Area, Save Calculated Items in a Web-Catalog, or Global variables to save intermediate calculations and make them available to other analysis. The Operational Data Schema (also referred to as Staging layer in previous releases) has been enriched with selected additional tables added in 9.3.3, 9.3.4 and 9.3.5 releases including PPM calendar, time sheet tables, new attributes from file folders, and Innovation Management dedicated attributes from Item Page 2. Additional Page 2 Fields introduced in 9.3.3 and 9.3.4 have been made available in the OPLA Configurator. Performance Improvements (for Agile PLM A9) have been achieved: The overall cycle time of the ETL load times have been improved using tuning and parallel processes, and the ability to select data by module has been introduced for Operational Data Schema.

OPLA

OPLA 3.5 is certified with sources Agile PLM 9.3.5, 9.3.4, 9.3.3, and PLM for Process 6.2., 6.1, 6.1.1, and technology stack Oracle Business Intelligence Enterprise Edition 11.1.1.9.0, Oracle Data Integrator 11.1.1.9.0, Oracle Database Server 12cR1,(version 12.1.0.1+), Oracle Database Server 11gR2, (version 11.2.0.3+).

OPLA 3.5 is available on Oracle Software Delivery Cloud for download under the following licensed product: ‘Oracle Product Lifecycle Analytics’. The OPLA 3.5 documentation library is available on OTN (part number E70337-01). Documentation updates are continuous and posted to OTN as they are completed.  Please always reference OTN for the latest guides. For a more detailed description of the release, refer to the release notes available with the release software and documentation.

Tuesday Jan 05, 2016

What to expect in the biggest PLM event of the year at the Modern Supply Chain Experience 2016

The biggest PLM event of the year is almost here! Come January 25-28, 2016 we'll be celebrating our 4th annual Modern Supply Chain Experience (previously Value Chain Summit), in San Jose, CA with over 2,000 PLM and Supply Chain leaders, partners, experts and students.

We have so many reasons to be excited this year about the Modern Supply Chain Experience. Watch this short video on the Top 5 PLM reasons to attend the event, for the rest 100 reasons, please keep reading:

Knock-out keynote speakers

Don’t miss your chance to hear ....

[Read More]

Monday Dec 21, 2015

PLM für Life Sciences - Was kann die Pharmaindustrie von anderen Industrien lernen?

Artikel von Henry Dünnebeil, Oracle PLM für Life Sciences

Neue Gedanken, Konzepte und Lösungen für abteilungs- und firmenübergreifende Prozesse

Die aktuelle Aufgabenstellung für die Pharmaindustrie ist im Blick auf sinkende Margen offensichtlich, aber nicht wirklich neu – einerseits müssen die Entwicklungszeiten und -kosten reduziert werden, um mehr Produkte schneller und wirtschaftlicher in die Märkte zu bringen, andererseits zwingen ständig neue Regularien (z.B. IDMP Identification of Medicinal Products) zu verstärkter interdisziplinärer Zusammenarbeit und effektiverem Informationsaustausch. Diese Probleme hatten andere Industrien auch und sie haben reagiert – sind deren Konzepte auch für Pharma adaptierbar?

Umdenken – weg von Insellösungen, hin zur Prozessintegration

Neue Herausforderungen zwingen zum Umdenken und zur Hinterfragung der bestehenden Prozesse. Viele Pharmaunternehmen setzen heute auf kollaborative Modelle, indem die Zusammenarbeit mit Markbegleitern, Partnern und Lieferanten intensiviert wird (Joint Development, Joint Marketing, In-Licensing , Outsourcing und M&A). – Gleichzeitig sollen die internen,  abteilungsübergreifenden Prozesse effektiver und transparenter gestaltet werden. Die erfolgreiche Umsetzung scheitert jedoch oft an der fehlenden IT Systemunterstützung. Was tun, wenn man sich entscheidet, Prozesse an externe Dienstleister auszulagern oder neue Bereiche oder ganze Unternehmen mit dem dazu gehörenden Produktportfolio zu akquirieren und möglichst schnell zu integrieren?

Die herkömmlichen ERP Systeme sowie die oft dokumentenbasierten Insellösungen in den Fachabteilungen sind für solche Modelle nicht geeignet, da sie für schnelle abteilungs- oder gar firmenübergreifende Prozessänderungen zu unflexibel sind und ein kollaboratives Informations- und Changemanagement auf einheitlicher und gesicherter Datenbasis nur bedingt unterstützen.
Daher stellt sich die Frage, ob die Konzepte und Systeme des „Product Lifecycle Management – PLM“, die genau dafür ausgelegt sind und in anderen Industrien (Automotive, Aero/Defense, HighTech) für ähnliche Aufgabenstellungen seit vielen Jahren erfolgreich eingesetzt werden, auch für Pharma die Lösung sind.

PLM for Pharma Pic 1

Product Lifecycle Managment ein „Muss“ für Pharma?

Es geht darum, wie die Daten und Abläufe aus den Bereichen Safety, Product Quality, Regulatory Affairs und CMC (TechOps, PharmOps, Pack/Label) transparenter miteinander verknüpft werden können und wie ein integriertes, abteilungsübergreifendes Change Management mit einer gemeinsamen Datenbasis und Produktinformationsplattform sicher realisiert werden kann.

PLM for Pharma Pic 2

Wir sind überzeugt, dass die Pharmaindustrie die PLM Konzepte ebenfalls effektiv einsetzen kann und muss, um die gesteckten Ziele zu erreichen und die Compliance-Kosten konsequent zu reduzieren.

Dabei braucht diese Transformation keineswegs als revolutionärer Prozess verstanden und angegangen werden, sondern kann als gesunde Evolution etabliert werden. Dazu gibt es verschiedenste Einstiegspunkte, von denen aus eine PLM Strategie Schritt für Schritt realisiert werden kann, wie z.B.: Packaging/Labeling/Artworks, (Post Market-) Change Management – Regulatory Submission Management – Product Quality – Supplier Collaboration – Health Authorities Exchange – u.v.m.

Der entscheidende Punkt dabei ist, die Prozessverbesserungen in den einzelnen Bereichen nicht mit neuen, spezialisierten Informationsinseln zu lösen (die dann zeit-, kosten- und wartungsintensive Integrationsprojekte auslösen), sondern ab jetzt das Gedankengut, die Prozesse und Systeme des „Product Lifecycle Management“, einzuführen: Weg von der mehrheitlich dokumenten-basierten Datenhaltung, hin zum strukturierten , kollaborativen Informationsmanagement auf einer gemeinsamen Plattform und Datenbasis. Keine einfache Aufgabe – müssen doch vermeintlich bewährte Prozesse und Systeme oder etablierte „Königreiche“ kritisch hinterfragt werden und nicht jeder Abteilungsleiter schätzt die neue Transparenz. Auch für die IT ist PLM eine besondere Herausforderung – stellt sich doch schnell heraus, dass die bewährten ERP-Systeme oder BPM-Werkzeuge, die modernen Kollaborations-anforderungen nur bedingt erfüllen können, d.h. ein PLM System muss als verbindende und kontrollierende Plattform implementiert werden.

Der Erfolg wird schnell sichtbar

Gelingt es dann dem Management eine unternehmensweite PLM Vision zu etablieren, ist der Erfolg meist nach wenigen Monaten klar sichtbar:

  • deutlich reduzierte Durchlaufzeiten für das Änderungsmanagement = Produkte sind schneller (wieder) im Markt
  • transparente, abteilungsübergreifende Prozesse/Workflows basierend auf verlässlichen und geprüften Daten ohne Medienbrüche
  • kurze, schnelle und gesichert nachvollziehbare Kommunikationswege aller beteiligten internen und externen Parteien
  • erheblich reduzierte oder eliminierte Compliance-Risiken
  • motivierte und von vielen „Informationsbeschaffungsprozessen“ befreite Mitarbeiter
  • klar messbare Effizienzsteigerungen und Kostenreduktion
  • Compliance als „Neben-Produkt“

Dabei ist PLM kein Privileg, das sich nur große Unternehmen leisten können – im Gegenteil - gerade für kleinere/mittlere oder junge Pharma/Biotech Unternehmen bietet PLM die ideale, schnell realisierbare Plattform – insbesondere auch wenn M&A Aktivitäten anstehen und schnell eine gemeinsame Produktinformationsplattform geschaffen werden muss. Für Big Pharma kann PLM zunächst in Teilbereichen eingesetzt und dann kontinuierlich erweitert werden. Mit dem Reifegrad der PLM Implementierung können dann Zug um Zug viele Insellösungen ersetzt werden (z.B. in den Bereichen Packaging/Labelling , Regulatory Submission Tracking, Quality/CAPA Management). Der Schlüssel für den Erfolg einer PLM Implementierung liegt im abteilungsübergreifenden Verständnis der erzielbaren Synergien. Daher ist es sinnvoll für PLM Präsentationen und Diskussionen neben der IT auch Vertreter aus TechOps, Regulatory, Quality und Development einzuladen.

PLM for Pharma Pic 3

Das Oracle PLM für Life Sciences Team berät Sie gerne und stellt Ihnen die Konzepte und  Lösungen in Ihrem Haus vor. Sprechen Sie mit uns!

Für weitere Information über Oracle PLM für Life Sciences besuchen Sie bitte unsere Website oder laden Sie dieses Dokument herunter.



Monday Dec 07, 2015

Top 5 PLM reasons to attend the Modern Supply Chain Experience 2016 [Video]

Join us at the annual Modern Supply Chain Experience, January 25-28, 2016 in San Jose, California.  Watch this short video on the top 5 PLM reasons to attend the most important Oracle PLM event of 2016 and register today.

Product development best practices have changed dramatically in recent years, join us at the conference, speak with our experts, ask questions and learn how you can transform your product value chain to deliver superior results.

Click here for the PLM agenda. 

Tuesday Dec 01, 2015

Oracle Innovation Management Cloud Live Demo - Friday, Dec 4

The best supply chains have a great product at the core. However, the biggest challenge for companies is selecting the right idea and converting it to a great product. Complex supply chains, alignment with corporate strategy, time and budget pressures, and fragmented processes exacerbate the problem.

Oracle Innovation Management Cloud can help companies ensure each idea is evaluated from a 360 degree perspective, prior to investment, to align within a balanced portfolio of growth strategies and confirm it can be delivered within time, budget, resource constraints.

Register now for the upcoming live webcast and see how Oracle Innovation Management Cloud can help you optimize your portfolio, drive top-line revenue growth, and innovate at lightning speed. 

Friday, December 4, 2015: 12:00 p.m. ET Register

For more details on Oracle Innovation Management Cloud please click here

IDMP – The new Challenge for Pharma - WHY THE MDM APPROACH IS INSUFFICIENT

IDMPHeart

Article written by Henry Dünnebeil, Oracle Sales Specialist  


The new upcoming EMA requirement to use the ISO standards for the IDentification of Medicinal Products turned out to be quite a wake-up call for drug makers, forcing them to (re-)think how to more effectively manage their product data cross-functionally to ensure and maintain compliance. Now hundreds of attributes from dozens of dispersed data sources including documents and databases have to be extracted, cleansed, validated, and then managed and change-controlled in a central repository to share with regulatory bodies – potentially a huge burden and scientific project – and very welcome work for armies of consultants and tool providers.

Since a couple of months, Oracle has been running a survey called “What is your IDMP Strategy?” (https://www.surveymonkey.com/s/oracleidmp), trying to find out how pharma companies are approaching the IDMP challenge, and if they see it as just another regulatory burden to meet or if they see the real opportunity behind it – to fundamentally change the way of managing product information – from a document-centric process to structured collaborative information management across internal and external domains and stakeholders.

And the outcome so far is that most respondents indeed do see IDMP as a cross-functional exercise – although mainly driven by Regulatory Affairs – and an opportunity to improve collaboration, but at the same time they see massive risks and an increased cost of compliance.

Many companies begin strategizing their IDMP implementation by thinking about it as an extension to xEVMPD. However, manual xEVMPD processes do not scale to IDMP data set sizes and much of the IDMP data isn't even in Regulatory Affairs. So many organizations think about building IDMP specific solutions and most of them quickly mature to adopting a master data management (MDM) approach. This is certainly an improvement because data is integrated more or less automatically with MDM.

So yes - the MDM approach can deliver IDMP compliance.

The short questions are: How - when - at which cost and efforts?

 Looking closer, more detailed questions arise – such as:

  • Can we use/extend our existing MDM to manage IDMP data and what are the efforts and risks ?
  • If not, shall we use IDMP to build a new MDM? Is this feasible at all?
  • Maybe we should establish an IDMP-specific MDM (e.g. as a Regulatory Product Information System) - but do we really want another data island?
  • How do we feed and synchronize the MDM system with clean IDMP data?
  • Where do we maintain IDMP relevant data – in MDM or the source systems?
  • Which system(s) govern IDMP data?
  • How do we ensure auditable change control of IDMP data?
  • How many integrations/synchronizations do we need to build and maintain?
  • Where do we handle the secured exchange on IDMP with regulators?
  • And what if another new regulation appears – will our MDM still be able to cope with it?
  • And finally: Can MDM unlock the full value opportunity that hides behind IDMP?

Do you recognize some of these questions and do you have answers? Here is our view:

IDMP is really about bringing together Clinical, Safety and Product Quality/CMC in a compliant data record. The only way to get there - without dramatically increasing the cost of compliance and doing business - is to change the ways of working from the traditional silo behavior to cross-functional process integration. Only the focus on process improvement will demonstrate unmatchable value compared to the classic back-office data based integration. So you need a solution that enables and supports this process – and that provides IDMP compliance as a “by-product”!

IDMP

Oracle with its Enterprise IDMP Foundations Suite clearly addresses the same benefit as MDM (automated data integration) but then goes one step further, addressing the shortcomings of MDM and culminating in a cross-functional integration of people, data, and processes. Based on proven, mature applications the Oracle IDMP approach is aimed to provide a ready to use IDMP repository with an integrated collaboration and change management platform out-of-the-box and then giving pharma companies the opportunity to re-think and improve their processes and integrations step by step.

Here are some of Oracle's differentiators vs. MDM projects and IDMP-specific applications:

IDMP2

So why only address half the problem with an MDM project when there's an opportunity to be IDMP ready in 3 months and unlock full “Product Lifecycle Management” capabilities in the future?

We are looking forward to discussing the topic with you in detail and, together with our Life Sciences Team, help you create the right strategy for IDMP and beyond.

Challenge us!


Friday Nov 06, 2015

Oracle Value Chain Summit 2016 Renamed Modern Supply Chain Experience 2016

The Oracle Value Chain Summit 2016 got a new name for 2016 - Modern Supply Chain Experience 2016.  Now in it's 4th year, the Modern Supply Chain Experience hosts over 2,000 PLM and Supply Chain leaders, partners, students and experts.  With roots in the legendary Agility User Conference for Agile PLM customers, this event has been specifically asked for by customers, and has welcomed more Oracle PLM users than any other.

Immerse yourself in four days of PLM sessions, training, exhibits, demos, advisory boards and workshops. Get the education, ideas and know-how you need to revamp your PLM infrastructure with unmatched access to PLM customers, experts, partners, and the product management team behind Agile PLM and PLM Cloud.

The Early Bird Registration Rate has been extended to November 15, but time is running out.  Don't miss this opportunity to attend the biggest Oracle PLM event of 2016!

Kerrie Jordan is Director, PLM Product Marketing at Oracle.  Follow her on Twitter @KerJordan. Learn more about Oracle PLM Cloud, Oracle Agile PLM, and Oracle Agile PLM for Process at www.oracle.com/plm

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