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Utilizing Technology Accelerator Methodology to Deliver Validated Oracle Argus Cloud in Record Time
Fran Bates, VP, Technology Services, Sciformix Corpo


Fran Bates, VP, Technology Services, Sciformix Corpo
In these scenarios where safety data isn’t integrated and data management is compromised, leading to a lack of control, many organizations seek to implement a seamless, validated, and secure best-of-breed safety solution. Migrating data to the cloud gives companies efficiency and leverages cost savings that internally hosted applications are unable to provide.
Case Study Example
While integrating safety data systems is essential, such a project can be complex since multiple data migrations are required from different data constructs, and a single validated drug safety technology system requires organizational agreement on its functionality.
A top global pharmaceutical company, offering prescription drugs across a wide range of therapeutic areas including Oncology, Gastroenterology, Anti-diabetic, Antibiotics, Cardiovascular, Pain Management, and Gynecology, required a single, consistent system for regulatory reporting, and sought to integrate two safety databases from different subsidiaries into a single Oracle Argus platform.
Delivering a high quality validated solution
As integrating safety data systems is a significant task, with impacts across the organization, it was sensible for this organization to select a drug safety software technology and services partner experienced in similar projects. Outsourcing this activity can be an efficient way to ensure project timelines are met, and the functionality required is delivered. A partner with such experience will execute on a proven implementation methodology, with specified deliverables and pre-validated software configurations.
The structured Sciformix Accelerator Methodology consisting of the following three components was used to seamlessly and rapidly implement a robust and quality solution for this customer in record time:
- Structured project oversight and management,
- Comprehensive IT global quality management systems
- Virtualization methodology and standardized validation

Finally, virtualization methodology and standardized validation speeds up project timelines and ensures quality across both the application and operating environments
By managing the project end-to-end, an outsourcing provider can hold demonstrations and workshops throughout the process. This ensures all users are familiar with the system and provides an opportunity for the solution to be adapted to user requirements and to propose technical solutions to problems. By employing a model where teams work together as a whole, while also having individual departments responsible for each function/role (as defined in Table 1 below), the project implementation can predictably progress. A comprehensive IT Global Quality Management Systems (QMS) designed in accordance with ISO27001:2013, ISO9001:2008, ITIL V3, GAMP, ICH, and other global best practices insures that the solution conforms to the highest levels of quality, regulatory and compliance standards. This Sciformix state of the art quality systems incorporate the latest regulatory guidance principals from around the world.
Finally, virtualization methodology and standardized validation speeds up project timelines and ensures quality across both the application and operating environments. Using these concepts in tandem with an IT quality management system allows a high quality, functionally-rich, accelerated and productive client-specific Argus safety cloud deployment. When developing the QA environment, a ‘gold copy’ can be created in order to reduce the validation level of effort (by having preapproved work instructions) and deployment efforts to commission the solution in only a few days.
In Summary
Implementing a drug safety technology solution with an established partner who can offer a flexible and proven project approach and structure that enables life science companies achieve better consistency and control over their drug safety data is an imperative for delivering safe and effective drugs. Additionally, life science companies can also look to maintain a cost-effective and unified system infrastructure by avoiding contracts with multiple legacy providers. Finally, they can reap the benefits of a secure single tenant architecture with controlled/planned system changes and system management downtime, which enable continued compliance and a constant state of audit-readiness.
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