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Software Developments in the Microsoft Environment
Other Tools, Instruments, and Procedures
Individual Software Development in the GxP Environment in Accordance with GAMP 5

Software Development in the Microsoft Environment

With more than 20 years' experience in the area of analysis and individual software development in the Microsoft environment, we have already implemented numerous individual solutions in a range of industries, in addition to our own product lines.
All the key MS technologies and frameworks have already been used here. At the moment, we are developing software using the following technologies:

• Microsoft .NET (as of V 3.5)
• MS SharePoint Services and MS SharePoint Server
• MS Workflow-Foundation (as of .Net V3.5)
• MS Silverlight
• MS ASP .Net
• MS Office plug-ins

More commissions from regulated industries and distributed development at different sites require a structured procedural model for the implementation of individual software systems or tools.
We usually work on the basis of the following procedural model (P-model/GAMP 5):

• Risk analysis
• Determination of loads based on risk analysis
  • Definition of risks that can be minimized through IT support
  • Identification of risks that can (also) occur through IT support
• Development of a specification with reference to risks (traceability)
• Development of use cases on the basis of loads (as functional specification); if required in joint workshops with the customer
  • Detailed description of the individual use cases including responsibilities/roles, conditions and much more
  • Accompanying development of an interactive prototype, which users/key users can use to directly simulate the described use cases
  • Reference to the particular load(s) (traceability)
• Modeling of the required charts on the basis of UML (domain, class, sequence charts and so on)
• Implementation of functionalities based on the modeling
• Parallel development of unit and regression tests. Additional development of automated interface tests (SmartBear or Automated QA TestComplete), if required
• Automated build, test, and deployment processes through the use of tools such as MS Team Foundation Server, Finalbuilder Server and so on
• Additional "manual" checks on the implemented functions. Tracaebility matrixes can be used here to check at all times the relationships between the individual functions. Correct functioning and smooth operation are therefore tested and documented in addition to the automated tests

Other Tools, Instruments, and Procedures

• Code reviews
  All newly created codes must be tested by several developers before they are integrated in a release (SmartBear CodeCollaborator)
• Continuous integration and automated builds including automated unit tests in various staging steps
• Detailed analysis and statistics in various contexts, as well as accurate tracking on implemented functions through the use of MS Team Foundation Server

Depending on when our support is requested, we may not always process all phases. However, for a number of reasons it is beneficial if we are involved in such processes at an early stage, for example to ensure clean and complete traceability across the various phases.

D-Process - WE DEVELOP VALID SYSTEMS...

Individual Software Development in the GxP Environment in Accordance with GAMP 5

To develop computer-assisted systems, we must consider company-internal, national and international guidelines for the FDA -> 21 CFR 210, AMWHV and AMG during the risk-based analysis as well as during the modeling. In addition, following, for example, the GAMP 5 guidelines, EU-GMP guidelines (app. 15), PIC/S and other guidelines is a prerequisite for the required validation and implementation of such applications in a company that is active in the pharmaceutical environment. In addition to our know-how, we also offer you strategies, processes and documents that are individually tailored to meet the regulatory requirements that apply to you. We work on the basis of the recommendations/specifications of GAMP 5 here.