Q. What advice do you have for drug makers in meeting the regulatory requirements?
'Be ahead of the curve' is the best advice we could give the industry. If possible, work with regulatory bodies to understand
key regulatory initiatives that are in progress and the potential impact of these regulations on the real world. Attempt to
influence the regulations by positive collaborative efforts across the industry. Undertake research and development efforts
to implement (or simulate), in a small laboratory environment, regulatory compliance before regulations are enacted.
Q. What challenges do you have in integrating technology from different vendors with your product (for example, with a Windows
Standards adoption is the most challenging aspect of integration projects. If two technologies adopt open standards, integration
becomes a nonissue. On the other hand, if two proprietary standards-based technologies need to be integrated, the result is
expensive and complex integration. Oracle is doing its part to enable low-cost integration by basing its integration platform
(Oracle Fusion Middleware) on open standards. Similarly, our application integration architecture (AIA), an open, standards-based
platform for business process management across Oracle, third-party and custom applications make it easy to integrate our
products with others.
Q. What integration issues do you see up and coming in all type of industries, and any specific challenges in the pharmaceutical
The traditional point-to-point integration model has outlived its utility. In most industries, chief information officers
are asking us for a hub-based integration framework that can incorporate an enterprise-wide common object model. Such an architecture
makes it easy to plug and play applications over time, without undertaking massive integration projects. Pharmaceutical companies
are beginning to adopt this model as well and are trying to understand the impact of regulatory constraints on the adoption
of such models.
Q. What are the top three applications that are typically interfaced with your products? And what are the challenges in interfacing
with applications with different languages (character sets)?
1. Factory-level shop floor (such as process control and process scheduling applications)
2. Statistical packages for highly advanced and specific data analysis
3. Third-party (legacy) business intelligence products. As long as all these applications accept unicode characters, integration
with these applications should not be an issue. However, some applications are less "internationally robust" than others,
and unique character sets, such as the Japanese character set, can pose a problem.
Q. Some companies face challenges in integrating MES (Manufacturing Execution Systems) to Enterprise Resource Planning (ERP)
applications. What is your company doing to help ease this integration?
Oracle is adopting the S95 standard aggressively and using this standard to guide our AIA strategy and approach, where appropriate.
Q. Do you have any thoughts on virtualization (e.g., virtual servers) and the impact of this to your business and to the pharmaceutical
[A few years ago, Oracle introduced] real application clusters, which support the deployment of a single database across a
cluster of servers—providing strong fault tolerance, performance, and scalability. We aggressively promote the virtualization
of an application environment through the implementation of machine clusters. This drastically lowers the cost of ownership,
as a group of several smaller machines is often a small fraction of the cost of a much larger machine, and the risk of failure
of a cluster is infinitesimal, as well. The adoption of this approach by the industry has been a strong validation of our
commitment to lower total cost of ownership for our customers.
Q. Do you outsource application development outside the US? Do you have any comments on the trend toward outsourcing?
Oracle has software development teams in several countries around the world. We have aggressively embraced globalization as
a key option for attracting the required talent to fuel our research and development engine. However, we do not typically
call this outsourcing, as software development is undertaken by Oracle employees in these countries who are trained on our
methodologies and standards and are subject to extremely stringent hiring criteria. So, we leverage a global pool of talent
without having to outsource a key business function.