Sympatec is using a completely defined and documented development process for all kinds of development, which has been proven in various audits of pharmaceutical companies. The process is completely specified in standard operating procedures (SOPs).

All requests for improvements of Sympatec's instrumentation, software, procedures, documentation etc. (i.e. users, sales, service, production etc.) send to us in an arbitrary format and path are filed with date, source and priority in the "request list".

An excerpt of this request list is periodically bundled and converted in development projects.

Sympatec is using the so called "V-model" as the standard life cycle model for all kinds of development projects,
i.e. this method is not limited to the development of software

For all development work a functional specification in written in the language of the "user". Simultaneously the criteria for the user acceptance test are defined in the same document: Each request has a direct relation to the related test. So at this level the "user" knows exactly what he will get at the end of the project.

In a second step the functional specification is converted into the design specification which is now written in the language of the developer. This happens simultaneously with the user acceptance test, which is converted into the system test. Again, each request has a direct relation to the related test. So at this level the "developer" knows exactly what he will get at the end of the project.

For software developments often a third level, the module design specification and the corresponding module testing is derived from the previous level, thus segmenting larger tasks into small modules.

The entries at all levels are traceably connected through the request and test numbers.

Finally a Gantt diagram assigns resources and time budgets to the individual tasks forming the overall project schedule.

Now the project work can start and the results are tested after completion using the pre-defined test criteria of the three levels. So the user gets exactly what was defined in the beginning at the user level.

Remark:

A well defined development process using a life cycle model is the pre-requisite for a software to achieve compliance with 21 CFR rule 11.