Sample software development procedures

Your sample Policy Procedure template is available for immediate download. The Sample Software Development Procedure Template The free software development policy and procedures sample will show you the format, writing style and content of the software development manual. Tiana van der Merwe, Development Manager — February 14, It gave me an idea on what to focus on for the department and it was easy to use as it is editable.

I just tailored the documents to suit our environment. Definitely assisted me to save time and money! Your email address will not be published. Save my name, email, and website in this browser for the next time I comment. Add to Wishlist. Usage scenarios with a focus on those related to hazards are specified. These will serve as input to the summative usability evaluation. Based on the device description, the usage scenarios and preliminary risk analysis, the next steps is to plan software development by defining software requirements.

These also include the user interface specification, e. The software system test plan is created based on the requirements. As requirements may change, the software system test plan is continuously updated to reflect those changes. Software requirements are verified through review by filling out the Checklist Software Requirements Review. Software requirements are reviewed. If the review is successful, move forward to the next step.

In that case, move back to the relevant step above. A software architecture is created and detailed design, if necessary.

As the software development process follows agile methodology, the software architecture may change as new knowledge is gained during implementation. The end result should be that both the implementation and the documented software architecture are synchronised. At minimum, an architecture diagram showing all software systems including databases and networks is created. For each software system, public interfaces, are documented, e. For each SOUP, we specify the name, version, manufacturer, website link incl.

Specifications The system and software specifications are merged in one phase. Design The architecture design and detailed design are merged in one phase. Tests The software tests and system tests are reduced in one phase The Software Tests Plan is the central document of this phase and verifies the content of the software requirements specifications.

All in one template - more simple If your software is very small and has a very low level of risk then, I suggest you to document it in a single document. Templates All-in-one simple software development template. Translations: Thanks to the contribution of Valentin Valchev, we have now the All-in-one template translated to Bulgarian: All-in-one simple software development template Bulgarian Thanks to the contribution of Pablo Ojeda, we have now the All-in-one template translated to Spanish: All-in-one simple software development template Spanish I invite you to translate the all-in-one template to your mother tongue it's the most downloaded template , I'll add your contribution here.

Explanations on the standard development process What I mean by standard development process is the one you find the most in the all the literature about software in medical devices.

Here are the principles or logics inside these templates. Principle of traceability The main principle in all these templates is the traceability of data between each document. Principle of verification of everything by tests The software development is driven in parallel with the risk analysis and, if necessary, the human factors engineering.

Principle of validation through traceability You make the validation easier if you defined well the traceability of every input and if you wrote all the documentation during the software development proccess. Software tools validation Update of july These templates are useful for the validation of software tools used in equipment or in QMS: The Validation Master Plan template itself, it contains general provisions for software validation, The Validation Protocol template , it contains the application of the VMP for a given system, The Validation Report template , it contains results of the validation protocol for a system, The Final Validation Report , it contains the conclusion of the validation of a system.

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