Whether a new software application is intended for a validated or non-validated environment, collecting, documenting, managing and using requirements remains a necessary and often daunting task. With this in mind, a small Pennsylvania-based firm called IM Visions has released a straight-forward tool called SimpleReq to help tackle this chore.
Having come from the biopharmaceutical industry, the founders of IM Visions are very much aware of the added rigors related to validation in a regulated environment. They have designed SimpleReq to meet the needs of the traditional Systems Development Life Cycle (SDLC) and of 21CFR11.
In short, SimpleReq is an MS-Office plug-in that will allow you to:
- Categorize and define requirements
- Associate requirements with test scripts
- Generate project documentation
- Manage releases and simplify documentation associated with application maintenance
SimpleReq is available from the IM Visions web site at an annual subscription price of $99.95. This is for a single instance of MS Office running on a single PC. You can select either the MS Office 2003 or MS Office 2007 version.
As you have probably inferred by now, the software is really an MS Excel and MS Word plug-in, making it possible to get off the ground in a matter of hours. Excel is used to manage the requirements data while Word is used to generate output reports.
For those who normally don’t bother to look at manuals, I would personally not recommend this approach with SimpleReq since the effective use of the tool does require an understanding of the underlying design philosophy and architecture.
Essentially, Simple-Req™ gives you five worksheets for managing requirements data and generating reports. The worksheets show up as normal tabs within an MS Excel workbook and are as follows:
- User Requirements (High Level Requirements)
- UR Test Scripts (Test High Level Requirements)
- Functional Requirements (Detailed Requirements)
- FR Test Scripts (Test Detailed Requirements)
The key productivity improvement delivered by SimpleReq is the automatic association (i.e. referential integrity) kept behind the scenes between user requirements and functional requirements. As you would expect, the relationships can be one-to-one, one-to-many, many-to-many or many-to-one. As it’s typically the case, for example, two or more user requirements may be expressed in a single user requirement statement and be converted to several related or unrelated functional requirements. Now relate this to the sheer number of requirement combinations to appreciate the power of SimpleReq to help you create, modify and manage them over the lifetime of a single project!
Another key capability of SimpleReq allows you to create, modify and manage descriptive information about the test scripts you will use during development, implementation, roll-out and post-rollout. Think of this as a project management function that assures that all of the requirements are tested in some manner with the linkages between the requirements and test scripts being maintained by SimpleReq.
The tool gives you separate test script worksheets for user requirements and functional requirements. This does not mean that you have to use both, just that you can depending on your preference. In a validated environment, for example, it is my contention that all testing should be done using the functional requirements. Put another way, NO testing should be done of the user requirements themselves. Some of you (e.g. diehard V model adherents) may claim that I’m simply wrong about this. The beauty of SimpleReq is that it does not care and lets you decide how the tool should behave. And, since we’re talking about the validated route at the moment, please note that SimpleReq will let you specify whether your test script is related to IQ, OQ or PQ.
SimpleReq also gives you configuration options under the assumption that each company follows somewhat different system development practices. For example, you can change the name of the worksheets, specify prefixes and/or suffixes for the requirement numbers, or specify pull-down lists (i.e. column values) that fit your environment. All of these user preferences can be specified without affecting the way the tool does its job behind the scenes.
The tool also recognizes that software projects are complex and must deal with changes in direction and scope during their life cycle. For example, while users may initially specify 100 requirements, only 60 may end up in the first Release, 25 in the second Release with the remaining 15 being deemed irrelevant. Under such a scenario, the tool must know what requirements belong in which release and which test scripts must be executed within each release. SimpleReq is able to do just that.
Of course, since you are working in the MS Excel environment, SimpleReq lets you use all of the native Excel functions to generate output from the requirements data. The tool does, however, come with a standard set of reports typically generated using requirements and test scripts. In a validated environment, this includes the generation of the traceability matrix.
A key reporting function of the tool is the piping of requirements data to MS Word documents by way of MS Word templates. This means that you can take a standard SimpleReq document template, modify it to meet your own internal standards, and then use the modified templates to create the final output documents.
The following documents are created using the MS Word templates function:
- User Requirements document
- Functional Requirements document
- Traceability Matrix
- UR Test Scripts documents
- FR Test Scripts documents
- Test Plan
- Test Summary
In this short review of SimpleReq, it was my intention to convey the key benefits of this inexpensive but feature-rich tool. I was given an in-depth overview of the product by the founders of IM Visions and have spent time working with it on my own PC. My bottom line conclusion is that SimpleReq provides a productive environment for managing application requirements, delivers sufficient flexibility to meet intra-company practices, and requires a very short learning curve. If you use it wisely, your investment (time and money) should pay for itself in a matter of days.