Application Development involves a complex set of services, which we generally refer to as “Application Services.”
Our first step, when developing new applications or new features within an existing application, is to collect requirements. Based on our analysis of these requirements, we prepare a development plan, which guides our design and implementation of the product.
At each stage of development, we test our work thoroughly to make sure our work meets the quality standards we’ve set. Once the development work is complete, we test the entire product (all features together) and validate according to defined acceptance criteria.
We approve a product for release only after it has been fully validated. Validation involves complete testing and qualification of the product. It also results in a comprehensive set of product documentation.
We support our customers’ key business functions by providing complete documentation in support of compliance, IT, and risk management.
Our app development and post-release support processes can be summarized as follows:
- Analysis of User Requirements Specifications (URS)
- Consultation with customers about the best way to achieve required functional fit
- Creation of Functional Specifications (FS) including data operations and the UI layer
- Creation of Design Specifications (DS)
- Design and Development (implementation of FS and DS)
- Parameterization (customization according to FS)
- Configuration (settings according to the URS)
- Application and Systems Integration (based on URS and FS)
- Testing and Validation
- Versioning and Release
- Support (entire lifecycle)
- Enhancements (continuous improvement)
Documentation and Regulatory Controls
We document the entire Software Lifecycle (URS > FS > DS > Development > Testing > Validation > Release) as part of our application services. However, since we develop applications in partnership with our customers, direction comes from the business areas who will use them.
As data stewards, our customers not only govern access for their users, they also help manage the policies and processes relating to the applications for their companies.
For higher-risk projects that fall under GAMP5 and/or GxP controls, we prepare special qualification documentation. These include installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
We prepare each of these qualification documents with reference to URS and FS, with traceability to the specific requirements contained within each, resulting in a fully-validated product.
As soon as a complete and detailed URS is prepared and signed-off, D3S prepares the following:
- Functional Specifications (FS) detailing all functional requirements that must be developed in addition to the established or out-of-the-box software functions already in place
- Design Specifications (DS) detailing the technologies and methodologies used to develop the various features described in the FS. This includes a description of the entire solution architecture, as well as the frontend features that determine the way an application looks and feels.
- Functional Risk Assessment detailing the areas of high and low risk within the FS.
- Validation Policy detailing all of the application functions or components that must be tested and validated (including how often, and according to which standards, validation must be performed; how validation is identified; and responsible persons, etc.)
- Validation Protocols detailing the various validation activities / steps, including test cases (IQ, OQ, PQ / UAT).
- Validation Reports summarizing the results of validation tests, once development is complete.