Industry pressures are prompting Life Sciences organizations to adopt new business models, enter new and emerging global markets, and expand alliances and partnerships in order to deliver high quality, safe drugs to market faster to improve health and well-being at a lower cost. To achieve these goals, life sciences organizations are becoming more strategic in how they manage information.
While ensuring regulatory compliance always has been and always will be a must, organizations are looking to drive efficiency and productivity across all aspects of the business. This requires breaking down artificial information silos and re-looking at how information flows from drug discovery through development, into commercial manufacturing and beyond. EMC can help!
A Proactive, Efficient and Simple Approach
As organizations strive to streamline how information is shared across the organization, they need to look at relationships that may exist between documents and how related communication flows between departments. Simultaneously, organizations can use this mapping of “information flows” as an opportunity to identify and build more automation into critical business processes while simplifying the user experience to make workers’ day-to-day jobs easier and more intuitive.
EMC Documentum for Life Sciences Solution Suite 4.0
Today, I am excited to announce EMC Documentum for Life Sciences solution suite, version 4.0. This release delivers proactive, automated, business rules and enhancements across the suite while ensuring a simple, user experience to reduce risk, streamline processes and boost worker productivity.
This release also serves as the foundation for future public cloud offerings in life sciences which will provide customers with ubiquitous access, unprecedented choice and flexibility in deployment models, faster implementation times and lower costs.
The 4.0 release, available later this quarter, provides specific business enhancements to each solution in the suite and also provides a broad set of capabilities that can be leveraged across the entire suite.
Enterprise information architecture: As mentioned, the documentation involved in bringing a drug to market must be continually shared across the organization and updated throughout its lifecycle. Therefore, documentation must cross functional boundaries. By leveraging common document and data models across the solution suite, organizations can seamlessly link and share content across the organization. Today, most organizations export and import documents from one system to another, resulting in version control and traceability issues, multiple copies with no official copy and manual processes resulting in extra work. With EMC, organizations can create a single authoritative source for regulated content, seamlessly link and share content across departments (or divisions) and provide proactive notifications to document authors, owners and users when document changes take place or actions and tasks are required.
EMC Documentum Quality and Manufacturing: Instills proactive notification and automation into key business processes such as periodic review, change request and the technical transfer processes to reduce risk and increase efficiency. Enhanced reporting quickly provides a snapshot of controlled document compliance.
EMC Documentum Research and Development: Extends the solution to include labeling and safety document inventories, the ability to use controlled templates to create virtual documents as well as a proactive, automated expiry review process.
EMC Documentum Submission Store and View: Boosts regulatory worker productivity through enhanced regulatory activity tracking and granular eCTD viewing.
EMC Documentum Electronic Trial Master File: Enables investigators to directly view, import and complete tasks on required clinical documentation via an investigator portal. Also, enables documents shared between clinical and regulatory functions to be linked creating one, source document and ensuring proactive notification when changes occur.
Want to Learn More?
If you are lucky enough to be attending Momentum at EMC World this week, please be sure to attend the life sciences sessions. In them, you’ll get a better understanding of these new enhancements, view demos and find out what’s next on the horizon.
Please visit us next week, May 11th – 13th, at the Drug Information Association (DIA) eRegulatory and Intelligence Conference in Philadelphia. We’ll have two experts presenting and members of our Product Development team will be available to talk with you about the specific challenges you’re facing.
If the process of transferring R&D documentation to Commercial Manufacturing is something your organization struggles with, keep an eye on EMC Spark. Jessica Kelley, Quality Product Manager, recently wrote a blog on the challenges associated with this process. In her next post, she’ll be explaining how you can automate the process (think – one click!) while ensuring traceability.
We are excited by all the new capabilities we have to help your organization become more strategic, efficient and productive. So tell us how we can help you!
• What are your most pressing challenges?
• What processes need to be automated (or need tighter integration?)
• Where do communications related to shared documentation break down?