Tools to automate IEC 62304 and FDA standard requirements - version-control

I am looking for a free software tool (or set of tools) to automate the document generation that requires the IEC 62304 and the FDA V&V standards (Software of Medical Equipments).
Basically, to maintain traceability between different documents, issue/bug trackers, SVN, source code, test cases, etc., report generation, document version control, project tracking, auditory functions, etc.

The Regulatory Documentation Manager (RDM) is a set of templates and python scripts which are designed to help automate IEC62304 compliance as much as possible. At its core, IEC62304 is all about using best practices to build high-quality software that has considered and mitigated as many risks as possible.
The stated design goals of RDM are:
Provide a generic template that covers common use-cases but is customizable.
Provide readable documents; e.g., other 62304 templates include many short deeply nested sub-sections. We use a maximum of two levels of nesting. We also provide flags (e.g., for different safety classes) that prune out irrelevant parts of the document, so that the documents only include what is necessary for the particular project.
Focused on software developers; the plan documents are intended to read and used frequently by the software developers on the team. Thus, wherever there was a tradeoff between making it easy to read for developers vs regulators/auditors, we optimized for developers. For example, we re-order IEC62304 sections to follow a more logical order for developers at the cost of being less parallel to IEC62304's structure.
Easy auditablility. In order to make it easier for regulators/auditors to read the document, we include auditor comments and links back to IEC62304. These links and notes are hidden by default, but there is a flag that enables turning them on. This way, we can use the "official" version without comments during our day-to-day work, but we can give the auditors two copies—both the "official" version and the "auditor" version that has all these extra notes.
Provide beautiful documents. A lot of times nobody readys requirements documents; we believe this is partly because the standard templates are large and ugly.
Make it as easy as possible to "upgrade" your documents when new versions of 62304 and related standards are developed.
The tool generates documents in markdown format, which are meant to be stored in source control, as well as in a PDF format. You can see examples of both the PDF and markdown versions here.
Please note that the tool is not complete, but it is under active development.

Not really related to regulatory compliance, but maybe Axiom can help. It can generate Word documents from your requirements.

There is a method called Model-Based Design by MathWorks which helps to integrate and automate most of the V&V processes required by the IEC 62304 for medical software development. In this way you can fulfil the steps all the way from requirements management to software integration and testing. The documentation artefacts required by the standard are automatically generated in the process.

Related

DITA for documenting software libraries

While this is not a question about DITA "programming" I'd still like to ask it within the stackoverflow community where most users would happen to be developers.
Our company uses a combination of Doxygen & MediaWiki to document software libraries (such as QSchematic). We feel like MediaWiki is not a good way of documenting software libraries.
My question: Should I start using DITA to document software libraries? I've spend quite a few hours working with DITA and DITA-OT and I think it's a good solution for documenting software components that the end users directly interacts with (eg. command line tools). However, I'm not quite sure whether DITA is a nice solution to document software libraries. After quite a lot of research it seems like DITA is not widely used by software (library) developers. DITA provides specialization that would allow setting up custom topics for this purpose but as nobody else on the web seems to be doing that I'm wondering whether there's anything fundamentally wrong with using DITA for this purpose.
DITA could be a good fit and provides all features you need or could need in the future. Maybe a tool like read-the-docs or Swagger would also fit, but that depends on the documents you want to create, so is difficult to answer without knowing your libraries and content. DITA has the benefit of reuse and flexibility. You can use external code fragments, reuse parts of your reference docs in conceptual topics and task topics giving you the power to achieve anything you could imagine.

Tools for building scheduling software

I am freelance programmer and i have a client who wants to build web-based software for scheduling/booking events. There is very few rules for possible booking options, but they are somewhat uncommon so there is no ready-made software to fully support them.
Anyway, besides that, the most important part is pretty common: calendar with events, reminders etc. So i believe there is some tools i can use, at least for that part.
What i'm interested in, is what tools can i use to build custom calendar, where i can write my own rules to prohibit user from booking in certain situations? Maybe there is some special framework (or, much more likely, plugins for web-frameworks) for scheduling software? If not, which ready-made software support maximum customization?
Well since you didn't specify what language your most familiar with i'll just stick to php.
Now you have a few options here.
A) You can start from a framework with some libraries and build from there. The major pro is that you can customize it like you want it. Downside would be more time actually making it, and since a client sets specific deadlines this might not be the right solutions.
B) You could start with something like Joomla. Now I do agree that it does have it's bloat, more than a million lines of code if I can remember. But with some searching I found some good booking systems that are built into modules.
If you go with B, you will be able to worry on details instead of the core grunt stuff. I've used joomla for a few different sites, and it's extremely customizable if you spend time with it.
In the end it's honestly related to your time restrictions, and your language of choice. Joomla is built with PHP if your wondering.
Hope this helps,
Daniel

What has been done in the field of versioning models?

We had a rather nice lecture about Model driven architecture by a guy from Model Labs.
One thing that got me intrigued was the version control for models ( not to be confused with different models of version control) - or the lack of thereof. By version control for models he meant a way to version XML, EMF files which preserves their semantic.
So, I'm interested in what has been done so far on that field (he mentioned something about SVN and Moodle, though I could have misheard him). The Google search yielded nothing so I'm turning to the wisdom of the Stack Overflow.
I'm looking mostly for information in the form of books, articles, links.
I don't know of a VCS alone dedicated to Model, because Model-base design is often part of a all chain of documents that need to be kept in sync.
Namely (not an exhaustive list):
requirements documents (from which you start modeling)
source code and documentations (generated and implemented from the model)
Plus, I never saw the GUI aspect fully solved in those tools (one model painstakingly organized a certain way might be versioned without layout information, and restored organized another way).
One tool I know of which covers all of those development processes is Modelio, which includes a "teamwork manager"
Another example (which I don't know as much about) would be metaCASE, which has an interesting paper "The Model Repository: More than just XML under version control", about DSM (Domain-Specific Modeling).
DSM: model-based software development approach that uses visual models as primary artifacts in the development process.
DSM raises the level of abstraction beyond normal programming languages by directly specifying the solution in a language that uses concepts and rules from the problem domain – a Domain-Specific Language (DSL).
It does summarize the problem:
There is increased awareness within the modeling arena of the need for
a central repository of system description information.
This is brought on by a growing recognition that only with a strong central repository can modeling tools be integrated, cope with large projects, provide full life-cycle support, produce complete documentation, perform system-wide validation and verification, and adequately control a project.
A full list of version control tools for models can be found here: http://modeling-languages.com/content/version-control-tools-modeling-artifacts
Check EMF framework Edapt
it provides the following features:
Edapt IDE Tooling:
Ecore Editor enhancement to create and maintain the history of an Ecore
Operation-browser to execute refactorings on an Ecore
Release Tooling to prepare a migration plugin from the Ecore history
Custom Migration Support
Edapt Runtime:
API to detect version of given model instances
API to migrate model instances with registered migration plugins

Should developer tools, languages, frameworks, etc. be standardized across an organization? [closed]

Closed. This question is opinion-based. It is not currently accepting answers.
Want to improve this question? Update the question so it can be answered with facts and citations by editing this post.
Closed 9 years ago.
Improve this question
The organization that I currently work for seems to be heading in the direction of dictating to software developers which tools, languages, frameworks, etc. must be used. However, nobody has convinced me that this is a good thing. The main argument I have heard is that it will make training easier. But, after developing software for over 10 years, I've never relied on training to learn how to use an IDE, programming language, or anything else; so I just can't relate.
With the rapid speed at which technology evolves, and the s-l-o-w-n-e-s-s at which I know the standards will adapt, I am concerned that my customers will have requirements that I won't be able to easily implement or won't be able to implement as efficiently as I should. For example, if there is a UI requirement for an auto-complete feature in a web app, and no API has been approved for this yet, I would need to implement auto-complete myself as opposed to using one of the many APIs that provide it out of the box.
A more radical example is if my customers wanted to have Google Wave features. In that case I would want the flexibility of configuring my development environment (including the IDE) and selecting appropriate frameworks (ex: GWT) to use.
Please provide feedback on whether or not you think that software developer tools, languages, etc should be standardized and a few points to support your argument.
There is a lot of benefit for standardization. My organization has fairly set standards on what technology we will use. We realize strong benefits in the following areas ...
Hiring. It is easy to describe what technologies we are looking for and make sure our recruiters are looking for the right people.
License/Software costs. I can buy enterprise licenses easily. It gives me the opportunity to keep costs down by letting me spend more with a smaller number of vendors and thus get more leverage.
Consistency of delivery. Our teams have a very good idea of what projects will take to build, rollout and maintain because they have done it with success before (and they know the pitfalls too).
Agility. I can have one team take over for another or one individual take over for another more easily because of standardization.
Quality. We have peer reviews across teams as well as QA across teams.
Without a consistent use of a technology stack, tools, languages and frameworks, these types of benefits would be more difficult to realize. I am not closed off to new technologies, but there has to be a concrete reason beyond "what if I want to ..."
A major issue with standardization is that once standards are out there, they get stamped in concrete and are difficult to change. This is why our corporate IT environment is stuck on IE 6, and the best change control system we have access to is CVS. Given this situation, some developers break the rules, and some find jobs at more innovative companies.
You have a mixed bag here.
I wouldn't standardize on IDEs, because every developer works differently. Those who are insanely proficient in emacs may see their performance suffer if forced to use Visual Studio. I optimize my Visual Studio experience with a 30" monitor and find it incredibly productive.
However, standardizing on some tools, such as SCons or make or something to build products is perfectly reasonable.
Banning some libraries and having a process where new libraries are either approved or not is also very reasonable. I know lots of companies that ban boost, or JQuery, or ban open source libraries in general, etc. And they had good reasons for doing it. I know I got fairly upset when an intern incorporated some random "security" library he found on the internet without running it by anyone.
In the end every company is different. You have to be standardized enough to avoid serious complications and issues as people come and go, or as new products are formed and organizational structures change. But you have to be flexible enough to avoid re-inventing every wheel you need.
The important thing is to have clear reasons for adopting a certain tool or banning some other tool or library. You can't just have management dictate that thou shalt use this and not that without consulting the engineering team and making the decision for good reasons. And once decisions are made those reasons should be written down and clearly communicated.
And also, if, in the end, your favorite tool or library isn't adopted, please don't whine about it. Be adaptable and do your job, or find a new one that makes you happier.
I once worked for a manager who felt the need to innovate at every level of his software development operation. Every development tool had to be cutting edge (preferably in beta). Many of the tools he asked us to use didn't have good documentation, and training was not available. Ultimately, most of the technology we tried simply didn't work. We wasted a lot of time churning through new technologies, only to dump them when it became clear we couldn't make progress.
I tried to make the case that innovation is perfect in the area where your value proposition lies. Innovation can also be used judiciously where standard techniques fail. But for most mundane tasks, using tried-and-true tools and methods should be the default. Less risk, less cost, less management attention needed. So you can focus time and energy on the areas where innovation has the most benefit.
So I think standardization has an important role. But blindly saying everything must be standard is just as sure to fail as my manager who thought everything must be innovative.
The number one argument in favor of standardization is that it maximizes the ability of the organization as a whole to use a common body of knowledge. Don't know how custom web controls are built in ASP.NET/C#? Ask Bill down the hall who has the knowledge. If you use different tools, such organizational wisdom is cut off at the knees. While it is not good to be restricted to a least common denominator (and hopefully your management will realize this) you should not overlook the benefits of shared experience!
UPDATE: I do not agree that innovation and standardization are polar opposites. Indeed, would we have nearly the level of web innovation if we still had the mishmash of networking standards characteristic of the 1980s? No we would not. Of course, we might have more innovation on new low-level networking protocols but is that really worth it? In its place, we've had an explosion of creativity within the bounds of TCP/IP and the Web standards (http, html, etc.)
The trick is knowing how to standardize without using it as an argument for closing down all new exploration. For example, we use only ASP.NET/C#/SQL Server in my company but I'm perfectly open to the use of new tools within this framework (we recently adopted the DevExpress reporting package, for example, supplanting the earlier standard).
Standardization is a must for a productive development team. However that doesn't mean that you can't revist the standards from time to time to adjust them to new technologies and trends.
Whether you develop operations software for internal clients, or products for external clients, there is no compelling reason not to standardize. You certainly did not give one.
Had you seen how companies are struggling with holding heterogenous products together that have been maintained for 10 years or more, and are now a conglomerate of various technologies that developers at some point thought made sense, you would not have asked this question.
From the top of my head, I could name at least 2 well-known software companies that will be driven out of business because their cost of maintenance has become so high that they can no longer compete (but I won't).
I think the misconception here is that suppressing individualism would supress innovation. That is simply not true. It is poor technical leadership that suppresses innovation.
One unpleasant consequence of standardization is that it tends to stifle innovation.
Innovation is scary. It involves cost and risk.
Standardization is not scary. It reduces cost and risk in the short term. Until your competitors have created a game-changing innovation. Then standardization is very costly.
It depends on the organization I think. One like Microsoft, yes, there should be a bit of a standard. A small business with one IT department, no. A larger business with several offices around the world ... maybe.
it all depends :-P
Assuming the organization has a broad suite of enterprise applications to manage, I'd say no for the following reasons, though I may be taking the message of everything being the same a bit too literally:
Compromise on using best-of-breed for systems, e.g. if all the databases are to be MS-SQL then any Oracle DB solution is thrown out. This would also apply to the fact that everyone using an IDE has to use the same one whether they be doing Data Warehouse report development, web applications, console applications or winForms. I'm thinking of systems like ERP, CRM, SCM, CMS, SSO and various other TLAs, FLAs, and SLAs. (LA = Letter acronyms for a decoding hint if you need it)
Upgrading by committee is another interesting issue. Where if each team can choose their tools and have one person that decides it is to upgrade things, e.g. start using Visual Studio 2008 instead of Visual Studio 2005, now have to determine at what threshold is it worth it to upgrade everyone simultaneously which may be a big headache if there are more than a few developers. For example, over the past 10 years when would there be IDE changes, framework changes, etc.?
Exceptions to the standards. Could a contractor bring in something not used in the organization if they believe it helps them build better software, e.g. Resharper or other add-ons that some contractors believe are very worthwhile that the organization doesn't want to spend the money to get? What about legacy systems that may make the standard become a bit unwieldy, e.g. this was built in ASP.Net 1.1 and so everyone has to have VS 2003 installed even if most will never use it?
Just my thoughts on this.
There are several good reasons to standardize.
First, it allows the enterprise better organizational flexibility, if everybody is more or less familiar with the same things. It also allows people to help each other better. I can't help with problems in the ASP.NET stuff, and there's not all that many people who can help me on the C++ side.
Second, it reduces support problems and expenses. Oracle and SQL Server are both decent products, but using both for similar functions is only going to cause problems. Not to mention that I've been in shops using several widely different platforms to do similar things, and it wasn't fun.
Third, there are some things that just have to be standardized. We couldn't operate half with VS 2005 and VS 2008, since we keep project files under source control. We had to pick a time and convert over.
Fourth, in some businesses, it simplifies the regulatory problems. I don't know what business you're in. I work at a place where we can get away with making mistakes right now, but I've also contracted at a bank and a utility, where it's necessary to be able to show auditors that everything is going in a standard way.
Fifth, it can simplify procurement, if you're dealing with software that costs money.
This doesn't particularly limit us, since if there's something we need that isn't standardized on we just go ahead and get it or do it.
If you want to make a business case against standardization, you'll need to have a business-related argument. Your argument seems to be that you won't be able to implement features the user wants, and that is a consideration. Got another argument?
There's nothing wrong with standardizing on an IDE that is rich enough to be configured for individual developers.
However, do make sure that you don't prevent individual developers from using additional tools, as long as the tools are licensed and that the use of the tool by one developer doesn't require all other developers to use it.
For instance, I happen to use NORMA to help me design databases. The output is SQL Server DDL (or anything else I want). I can make the DDL part of the project without making my NORMA source part of it. Later developers do not need to use NORMA to work on the project.
On the other hand, if I decided to use the Configuration Section Designer to create configuration sections, then future developers would also have to use it. A decision would need to be made about whether to use that tool.
The company I work for uses C#, ASP.NET, JavaScript and generates HTML. The advantages over and above those mentioned above are that there is a perception of improved velocity for maintenance and adaptive changes. The disadvantages include generating some boredom for people who are technically savvy (geeky) and prefer to use a mix and match of languages, depending on what they fancy is better suited, or for 'performance reasons'.
Technical and personal supervision is always good to have when you are developing as fast as you can to meet tight deadlines and competing in a highly saturated market for web development.

How do I plan an enterprise level web application?

I'm at a point in my freelance career where I've developed several web applications for small to medium sized businesses that support things such as project management, booking/reservations, and email management.
I like the work but find that eventually my applications get to a point where the overhear for maintenance is very high. I look back at code I wrote 6 months ago and find I have to spend a while just relearning how I originally coded it before I can make a fix or feature additions. I do try to practice using frameworks (I've used Zend Framework before, and am considering Django for my next project)
What techniques or strategies do you use to plan out an application that is capable of handling a lot of users without breaking and still keeping the code clean enough to maintain easily?
If anyone has any books or articles they could recommend, that would be greatly appreciated as well.
Although there are certainly good articles on that topic, none of them is a substitute of real-world experience.
Maintainability is nothing you can plan straight ahead, except on very small projects. It is something you need to take care of during the whole project. In fact, creating loads of classes and infrastructure code in advance can produce code which is even harder to understand than naive spaghetti code.
So my advise is to clean up your existing projects, by continuously refactoring them. Look at the parts which were a pain to change, and strive for simpler solutions that are easier to understand and to adjust. If the code is even too bad for that, consider rewriting it from scratch.
Don't start new projects and expect them to succeed, just because your read some more articles or used a new framework. Instead, identify the failures of your existing projects and fix their specific problems. Whenever you need to change your code, ask yourself how to restructure it to support similar changes in the future. This is what you need to do anyway, because there will be similar changes in the future.
By doing those refactorings you'll stumble across various specific questions you can ask and read articles about. That way you'll learn more than by just asking general questions and reading general articles about maintenance and frameworks.
Start cleaning up your code today. Don't defer it to your future projects.
(The same is true for documentation. Everyone's first docs were very bad. After several months they turn out to be too verbose and filled with unimportant stuff. So complement the documentation with solutions to the problems you really had, because chances are good that next year you'll be confronted with a similar problem. Those experiences will improve your writing style more than any "how to write good" style guide.)
I'd honestly recommend looking at Martin Fowlers Patterns of Enterprise Application Architecture. It discusses a lot of ways to make your application more organized and maintainable. In addition, I would recommend using unit testing to give you better comprehension of your code. Kent Beck's book on Test Driven Development is a great resource for learning how to address change to your code through unit tests.
To improve the maintainability you could:
If you are the sole developer then adopt a coding style and stick to it. That will give you confidence later when navigating through your own code about things you could have possibly done and the things that you absolutely wouldn't. Being confident where to look and what to look for and what not to look for will save you a lot of time.
Always take time to bring documentation up to date. Include the task into development plan; include that time into the plan as part any of change or new feature.
Keep documentation balanced: some high level diagrams, meaningful comments. Best comments tell that cannot be read from the code itself. Like business reasons or "whys" behind certain chunks of code.
Include into the plan the effort to keep code structure, folder names, namespaces, object, variable and routine names up to date and reflective of what they actually do. This will go a long way in improving maintainability. Always call a spade "spade". Avoid large chunks of code, structure it by means available within your language of choice, give chunks meaningful names.
Low coupling and high coherency. Make sure you up to date with techniques of achieving these: design by contract, dependency injection, aspects, design patterns etc.
From task management point of view you should estimate more time and charge higher rate for non-continuous pieces of work. Do not hesitate to make customer aware that you need extra time to do small non-continuous changes spread over time as opposed to bigger continuous projects and ongoing maintenance since the administration and analysis overhead is greater (you need to manage and analyse each change including impact on the existing system separately). One benefit your customer is going to get is greater life expectancy of the system. The other is accurate documentation that will preserve their option to seek someone else's help should they decide to do so. Both protect customer investment and are strong selling points.
Use source control if you don't do that already
Keep a detailed log of everything done for the customer plus any important communication (a simple computer or paper based CMS). Refresh your memory before each assignment.
Keep a log of issues left open, ideas, suggestions per customer; again refresh your memory before beginning an assignment.
Plan ahead how the post-implementation support is going to be conducted, discuss with the customer. Make your systems are easy to maintain. Plan for parameterisation, monitoring tools, in-build sanity checks. Sell post-implementation support to customer as part of the initial contract.
Expand by hiring, even if you need someone just to provide that post-implementation support, do the admin bits.
Recommended reading:
"Code Complete" by Steve Mcconnell
Anything on design patterns are included into the list of recommended reading.
The most important advice I can give having helped grow an old web application into an extremely high available, high demand web application is to encapsulate everything. - in particular
Use good MVC principles and frameworks to separate your view layer from your business logic and data model.
Use a robust persistance layer to not couple your business logic to your data model
Plan for statelessness and asynchronous behaviour.
Here is an excellent article on how eBay tackles these problems
http://www.infoq.com/articles/ebay-scalability-best-practices
Use a framework / MVC system. The more organised and centralized your code is the better.
Try using Memcache. PHP has a built in extension for it, it takes about ten minutes to set up and another twenty to put in your application. You can cache whatever you want to it - I cache all my database records in it - for every application. It does wanders.
I would recommend using a source control system such as Subversion if you aren't already.
You should consider maybe using SharePoint. It's an environment that is already designed to do all you have mentioned, and has many other features you maybe haven't thought about (but maybe you will need in the future :-) )
Here's some information from the official site.
There are 2 different SharePoint environments you can use: Windows Sharepoint Services (WSS) or Microsoft Office Sharepoint Server (MOSS). WSS is free and ships with Windows Server 2003, while MOSS isn't free, but has much more features and covers almost all you enterprise's needs.