EPDM and FDA Compliance
One of the common misconceptions about 21 CFR Part 11 (the body of law that governs medical device makers in the United States) is that there are software packages available that can make companies compliant with the law. Being compliant with these regulations requires that your process be compliant, and even the best software can’t really make you 21 CFR Part 11 compliant. However, software can certainly provide enablers and automation to allow for faster, more efficient, better integrated, and easy-to-use processes. SolidWorks EPDM has some functions and tools built-in to help companies conform to the FDA requirements. Continue Reading
The Aras Innovator workflow engine has many options and features that enable the modeling of robust business processes in PLM. One of the options available is the capability to authenticate users before they can complete an activity. You may be asking, why would I want to authenticate a user in a workflow? Or, isn’t supplying a username and password when the user starts Innovator sufficient? In many cases, enabling authentication in workflow is not necessary and login authentication is sufficient to monitor workflow activity actions. However, some activities represent approvals or legal acknowledgments and can result in the release of parts (items), BOMs, and documents. Depending on your business and your PLM strategy, these activities may require additional authentication to be in alignment with regulatory compliance requirements for providing electronic signatures. 
For those of you familiar with the key players at Dassault, ENOVIA, and SmarTeam over the years, you probably know 
There are two extremes when driving components in design automation systems: on one end of the spectrum, you can allow users to only select pre-defined components (Configure-to-Order) and on the other end of the spectrum, you can let users create their own parts by driving the dimensions and features of the parts with infinite flexibility (Engineer-to-Order). Which of these models is TactonWorks following with variants? Are we just selecting variants, or are we customizing them, or are we doing both? 
As developers, we’re known to tweak things to get them just exactly like we want them. So here’s a quick tip on getting your own menu entry in Windows 7 context menus, and some sample code that makes a directory listing for a selected folder. With this sample code, you can choose any Windows folder and create a text file listing of all files and subfolders contained within the selected folder. 
For those of you running an Oracle database as your repository for SmarTeam, check out this helpful utility. The SmarTeam Database Oracle General Report tool is a collection of plain text files containing batch commands and SQL statements that can generate a detailed HTML report of key Oracle statuses and settings. The tool is available from 
Just this month (October 2010), Aras announced the release of Service Pack 2 for Innovator 9.2.0. The service pack resolved several issues identified by subscribers, provided some performance enhancements, and addressed some issues related to error handling and messaging. 
