Tuesday Jun 26, 2012

USDM and Oracle Offer a New Part 11 Compliant Solution for Life Sciences

Guest post today provided by Oracle partner, USDM 

Regulated Content in WebCenter
USDM and Oracle offer a new Part 11 compliant solution for Life Sciences
 (White Paper)

Life science customers now have the ability to take advantage of all of the benefits of Oracle’s WebCenter Content, a global leader in Enterprise Content Management.   For the past year, USDM has been developing best practice compliance solutions to meet regulated content management requirements for 21 CFR Part 11 in WebCenter Content. USDM has been an expert in ECM for life sciences since 1999 and in 2011, certified that WebCenter was a 21CFR Part 11 compliant content management platform (White Paper).  In addition, USDM has built Validation Accelerators Packs for WebCenter to enable life science organizations to quickly and cost effectively validate this world class solution.

With the Part 11 certification, Oracle’s WebCenter now provides regulated life science organizations  the ability to manage REGULATORY content in WebCenter, as well as the ability to take advantage of ALL of the additional functionality of WebCenter, including  a complete, open, and integrated portfolio of portal, web experience management, content management and social networking technology.  Here are a few screen shot examples of Part 11 functionality included in the product: E-Sign, E-Sign Rendor, Meta Data History, Audit Trail Report, and Access Reporting.

Access Reporting
Audit Trail Report



Metadata history

Gone are the days that life science companies have to spend millions of dollars a year to implement, maintain, and validate ECM systems that no longer meet the ever changing business and regulatory requirements.  Life science companies now have the ability to use WebCenter Content, an ECM system with a substantially lower cost of ownership and unsurpassed functionality.

Oracle has been #1 in life sciences because of their ability to develop cost effective, easy-to-use, scalable solutions which help increase insight and efficiency to drive growth for their customers.  Adding a world class ECM solution to this product portfolio allows life science organizations the chance to get rid of costly ECM systems that no longer meet their needs and use WebCenter, part of the Oracle Fusion Technology stack, with their other leading enterprise applications.

USDM provides:

•    Expertise in Life Science ECM Business Processes
•    Prebuilt Life Science Configuration in WebCenter
•    Validation Accelerator Packs for WebCenter

USDM is very proud to support Oracle’s expanding commitment to Life Sciences….

For more information please contact:  khutchings@usdatamanagement.com

Oracle will be exhibiting at DIA 2012 in Philadelphia on June 25-27. Stop by our booth (#2825) to learn more about the advantages of a centralized ECM strategy and see the Oracle WebCenter Content solution, our 21 CFR Part 11 compliant content management platform.

DIA 2012

Thursday Jun 07, 2012

Unlocking Productivity

Unlocking Productivity in Life Sciences with Consolidated Content Management

by Joe Golemba, Vice President, Product Management, Oracle WebCenter

As life sciences organizations look to become more operationally efficient, the ability to effectively leverage information is a competitive advantage. Whether data mining at the drug discovery phase or prepping the sales team before a product launch, content management can play a key role in developing, organizing, and disseminating vital information.

The goal of content management is relatively straightforward: put the information that people need where they can find it. A number of issues can complicate this; information sits in many different systems, each of those systems has its own security, and the information in those systems exists in many different formats.

Identifying and extracting pertinent information from mountains of farflung data is no simple job, but the alternative—wasted effort or even regulatory compliance issues—is worse. An integrated information architecture can enable health sciences organizations to make better decisions, accelerate clinical operations, and be more competitive.

Unstructured data matters Often when we think of drug development data, we think of structured data that fits neatly into one or more research databases. But structured data is often directly supported by unstructured data such as experimental protocols, reaction conditions, lot numbers, run times, analyses, and research notes. As life sciences companies seek integrated views of data, they are typically finding diverse islands of data that seemingly have no relationship to other data in the organization. Information like sales reports or call center reports can be locked into siloed systems, and unavailable to the discovery process. Additionally, in the increasingly networked clinical environment, Web pages, instant messages, videos, scientific imaging, sales and marketing data, collaborative workspaces, and predictive modeling data are likely to be present within an organization, and each source potentially possesses information that can help to better inform specific efforts.

Historically, content management solutions that had 21CFR Part 11 capabilities—electronic records and signatures—were focused mainly on content-enabling manufacturing-related processes. Today, life sciences companies have many standalone repositories, requiring different skills, service level agreements, and vendor support costs to manage them. With the amount of content doubling every three to six months, companies have recognized the need to manage unstructured content from the beginning, in order to increase employee productivity and operational efficiency.

Using scalable and secure enterprise content management (ECM) solutions, organizations can better manage their unstructured content. These solutions can also be integrated with enterprise resource planning (ERP) systems or research systems, making content available immediately, in the context of the application and within the flow of the employee’s typical business activity. Administrative safeguards—such as content de-duplication—can also be applied within ECM systems, so documents are never recreated, eliminating redundant efforts, ensuring one source of truth, and maintaining content standards in the organization.

Putting it in context
Consolidating structured and unstructured information in a single system can greatly simplify access to relevant information when it is needed through contextual search. Using contextual filters, results can include therapeutic area, position in the value chain, semantic commonalities, technology-specific factors, specific researchers involved, or potential business impact.

The use of taxonomies is essential to organizing information and enabling contextual searches. Taxonomy solutions are composed of a hierarchical tree that defines the relationship between different life science terms. When overlaid with additional indexing related to research and/or business processes, it becomes possible to effectively narrow down the amount of data that is returned during searches, as well as prioritize results based on specific criteria and/or prior search history. Thus, search results are more accurate and relevant to an employee’s day-to-day work.

For example, a search for the word "tissue" by a lab researcher would return significantly different results than a search for the same word performed by someone in procurement.

Of course, diverse data repositories, combined with the immense amounts of data present in an organization, necessitate that the data elements be regularly indexed and cached beforehand to enable reasonable search response times. In its simplest form, indexing of a single, consolidated data warehouse can be expected to be a relatively straightforward effort.

However, organizations require the ability to index multiple data repositories, enabling a single search to reference multiple data sources and provide an integrated results listing.

Security and compliance
Beyond yielding efficiencies and supporting new insight, an enterprise search environment can support important security considerations as well as compliance initiatives. For example, the systems enable organizations to retain the relevance and the security of the indexed systems, so users can only see the results to which they are granted access. This is especially important as life sciences companies are working in an increasingly networked environment and need to provide secure, role-based access to information across multiple partners.

Although not officially required by the 21 CFR Part 11 regulation, the U.S. Food and Drug Administraiton has begun to extend the type of content considered when performing relevant audits and discoveries. Having an ECM infrastructure that provides centralized management of all content enterprise-wide—with the ability to consistently apply records and retention policies along with the appropriate controls, validations, audit trails, and electronic signatures—is becoming increasingly critical for life sciences companies.

Making the move
Creating an enterprise-wide ECM environment requires moving large amounts of content into a single enterprise repository, a daunting and risk-laden initiative. The first key is to focus on data taxonomy, allowing content to be mapped across systems. The second is to take advantage new tools which can dramatically speed and reduce the cost of the data migration process through automation. Additional content need not be frozen while it is migrated, enabling productivity throughout the process.

The ability to effectively leverage information into success has been gaining importance in the life sciences industry for years. The rapid adoption of enterprise content management, both in operational processes as well as in scientific management, are clear indicators that the companies are looking to use all available data to be better informed, improve decision making, minimize risk, and increase time to market, to maintain profitability and be more competitive.

As more and more varieties and sources of information are brought under the strategic management umbrella, the ability to divine knowledge from the vast pool of information is increasingly difficult. Simple search engines and basic content management are increasingly unable to effectively extract the right information from the mountains of data available.

By bringing these tools into context and integrating them with business processes and applications, we can effectively focus on the right decisions that make our organizations more profitable.

More Information

Oracle will be exhibiting at DIA 2012 in Philadelphia on June 25-27. Stop by our booth (#2825) to learn more about the advantages of a centralized ECM strategy and see the Oracle WebCenter Content solution, our 21 CFR Part 11 compliant content management platform.

DIA 2012

Wednesday May 30, 2012

Oracle is #1 in Life Sciences!

Guest post today by: John Klinke, Senior Principal Product Manager, Oracle WebCenter Content

Based on the announcement last week at EMC World about Documentum for Life Sciences, it looks like EMC is starting to have regrets about pulling out of the life sciences space over the last few years. Certainly their content management customers and partners in life sciences have noticed their retreat. Many of them are now talking to us about WebCenter Content since they’ve seen the writing on the wall regarding Documentum’s decline, including falling revenue, shrinking investment, departure of key executives, and EMC’s auditing of existing customers.

While EMC has been neglecting the life sciences industry over the last few years, Oracle has been increasing its investment and commitment by providing best-of-breed solutions to enable pharmaceutical, medical device, biotech and CRO companies to improve productivity and drive innovation. As a result, according to IDC Health Insights, Oracle is #1 in life sciences. From research and development through clinical development and manufacturing to sales and marketing, Oracle provides the solutions that life sciences companies depend on to accelerate R&D, expedite clinical trials, and speed time to market.

Specifically for Oracle WebCenter, our life sciences business is booming thanks to our comprehensive offerings led by Oracle WebCenter Content, our 21 CFR Part 11 compliant enterprise content management platform. Unlike Documentum, WebCenter Content is all about keeping the cost of ownership low - through simplicity, flexibility, and out-of-the-box integrations. WebCenter Content is a single, comprehensive ECM platform that can handle all your content management needs, from controlled documents to digital asset management, records management and document imaging and capture. And it is much more flexible, letting you do configuration changes instead of customizations to meet your business needs. It also saves you money by being pre-integrated with the rest of the Oracle Fusion Middleware technology stack and with leading enterprise applications like Siebel (including Siebel CTMS), Primavera, E-Business Suite, JD Edwards and PeopleSoft.

So if you think EMC’s announcement last week was too little and too late, I’m happy to report that Oracle is here to help. Back in October, we announced our Move Off Documentum offer, which provides a 100% trade-in credit for your Documentum licenses when you purchase Oracle WebCenter, and the good news is, this offer is still available for a limited time. So stop maintaining Documentum and start innovating with Oracle WebCenter. For more details see www.oracle.com/moveoff/documentum.


Oracle WebCenter Content is part of Oracle WebCenter: Oracle WebCenter is the engagement platform powering exceptional experiences for employees, partners and customers. Ensure timely, relevant and accurate information with enterprise content management


« July 2016