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Systems done for a regulated pharmaceutical manufacturing environment have some unique characteristics. They must emulate the older paper form information management techniques. In this approach, all entry was done in pen. There were no erasures allowed, just strikethroughs and neat re-entry right above, initialed and dated.

That way, you could see both the original entry and the changes. In a system, however, this means rethinking normal user interface approaches. No editing of fields in a way that looses the original value!

There are both data base and user interface implications to this requirement. In the data base, you could change a record, but you had to keep the original record. In the User Interface, both the “final” value and the “original” value, and any values in between had to be displayed. In the printed version, the form was printed in the top half of the page, and a change log was printed in the lower half. It was a challenge to mimic the paper strikethrough process throughout computer storage, presentation, and input.

Here is a great example of a subtle but real status field. Clearly, it was unworkable to prohibit a free entry and change process during the origination of the document. It was not reasonable to log every error, misspelling, and change in the initial data entry. So, we used a two step form creation process – Entry and Commit. Before the document was Committed, the fields could change freely. After the document was Committed, every change to a field was logged and retained. And, of course, we needed a status field to tell the system whether the document could be edited freely or not.

This “Entry Status” was critical to the proper functioning of the system, but didn’t show anywhere in the business flow analysis or the existing forms. This design element popped out of the prototyping process.

There is a role for both iterative prototyping processes and sequential “waterfall” processes in software development. I find it is not “either – or”. The trick is to know which mix, or “recipe” to use for any given project.

But that is a whole ‘nother topic.