Architecture
Virtx e-platform is be based on an open, multi-tier architecture with clear separation between the tiers, namely the presentation (for the user interface), the business rules (the middle tier) and the data tiers. It based on technologies that are industry standard. It is based on the following architectural principles:
- Open
- Multi-tier
- Usable
- Scalable
- Secure
- Maintainable
- Flexible
The set of products in the Virtx e-platform are de-coupled i.e. the e-platform is not a monolithic system where all products are tightly knitted with one another. They are designed to be flexible enough that products can be chosen from the list available via the platform to meet the requirements. Products can be added later on as new requirements and standards are mandated. Additionally, these products can function independently or collaboratively to exchange information and streamline business processes. The specific extent of collaboration and exchange can be configured and changed gradually over a period of time.
In addition, the platform also provides products to test new and emerging standards along with conversion tools to convert data from legacy standard to new standards. The platform gives the gives customers the opportunity to test drive tools for new standards and provide feedback to the Agencies piloting new standards.
The wide range of products offers unique collaboration capabilities and significant advantages. Since the products can collaborate and exchange information data from down stream activities can easily feed upstream activities and vice-verse. For example, data collected for submissions over a period of a year can be used for better forecasting and planning. The actual resources used and time spent is tracked for the actual submissions and this can be leveraged to better plan and forecast submissions and resources in future. The planner also is able to leverage dependencies and help managers make better planning decisions to meet their goals.
Virtify’s rich product portfolio, coupled with its well defined processes and experienced regulatory resources provides clients with a wide range of options that are flexible to meet their requirements. A client may choose not to use some of these products or use products or tools of their preference. Virtify’s approach is flexible to accommodate other products or introduce these products as and when the client sees they are in a position to introduce them into their existing business processes.
Key Features
The following are key features of the Virtx Platform – these features are included in every product in the platform:
- Web-based Interface with AJAX : Powerful desktop-like environment over the web; no client-side installs
- Role Based Access Control: Multi-level security and authentication; granular role-based control
- Integrated Reporting: Allows for generation of pre-configured as well as canned/ad hoc reports
- Search: Powerful search mechanisms—Keyword, Search by Example, Advanced Search
- Life Cycle History and Audit Trails: Comprehensive tracking of document or content lifecycles, including lifecycle stage, version, document/submission type, filing type and other meta-data.
- Infrastructure Support: Supports multiple databases (SQL Server, Oracle etc.), document management systems (Documentum, Livelink etc.) and other infrastructure components (Safety Systems, CDMS etc.)
- Regulatory/Quality Compliance: Configured for 21 CFR Part 11; Validated Solution