Did you know that you can still comply with the FDA’s 21 CFR Part 11 policy for electronic document management without the hassle and frustration of using pen and paper or working in Microsoft Word? Paper and document-based systems really hamper a company’s ability to decrease time to market and enable more frequent “voice of the customer” feedback. It’s vital that life sciences companies understand they can remain compliant with the FDA by merely using the right system to manage records and electronic signatures.
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponReporting
When it comes time to submit required paperwork to the FDA for an audit or product submission, it’s important to use an electronic data management system to ensure your reports are completed promptly, professionally, and in compliance with all FDA requirements. The FDA dictates that your submissions must include a description of device design, how the design was implemented and tested, proof that risks and hazards were identified and handled appropriately, and ultimately provide clear traceability, all of which can require days or even weeks of effort to compile manually. The right electronic data management system will collect and archive that information and decisions in real-time as the project is in progress. At submission time, it’s just a matter of running a few reports and you’re ready to take that big step in seeking approval to get your product to market. To read more about submissions requirements, check out the FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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In a recent post, I introduced the Seapine ALM Reporting Platform. In this video, I provide an overview of the install process and configuration to get the data warehouse populated. Once the warehouse is populated, it can be queried for reporting using any reporting tool that is compatible with the RDBMS you use for the warehouse (SQL or Oracle).
There is a new addition to Seapine ALM product suite—Seapine ALM Reporting Platform (Seapine ALM RP). Seapine ALM RP is a database warehouse that can contain data from the entire Seapine ALM suite. This means you can have data from the Seapine License Server, TestTrack, Surround SCM, and QA Wizard Pro in a single, normalized database.
Seapine ALM Reporting Platform
Seapine ALM RP is not for everyone. If you are already getting the reports you need from the products, then Seapine ALM RP is not for you. For those of you who need custom reports that may span different projects in TestTrack, different mainlines in Surround SCM, or different product databases, Seapine ALM RP is right for you.
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponAnalyzing security group permissions in Surround SCM just got a whole lot easier, thanks to a new report available in the 2011.1 release. When you create a new report in Surround SCM, you now have the option of selecting Security Group on the Select Report Type window.
Select Report Type Window
This report allows you to report on all security groups or selected ones. The report lists all of the permissions and indicates if a permission is enabled for the security group. The mechanics of the report are similar to the TestTrack security group comparison report released last October.
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponTestTrack security groups allow the administrator to configure the level of access a user has. From having access to only specific workflow events to only seeing fields that apply to the user, security groups allow the administrator to ensure that the user is not flooded with options and fields. As your implementation of TestTrack grows, your number of security groups may as well. To easily compare these groups and analyze why one gives users a level of access that another does not, TestTrack 2011 introduces a new report that allows you to compare security groups in a more efficient manner. This video shows you how.
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TestTrack’s cumulative flow chart and folder task board reports group items in a selected folder into Not Started, In Progress, Done, and Accepted categories. At first glance, you may think the categories are related to an item’s workflow state, but they are not.
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponI wrote a sample application that can send a TestTrack report to one or more email addresses. This is a console application, so you can create a batch file and use Windows Scheduler to run it at pre-determined times. The application is written in C# using the .NET framework version 3.5. The email is sent using the System.Net.Mail namespace, specifically, the SmtpClient class. If you’re not sure whether this will work in your environment, you can find more information here.
Share on Technorati . del.icio.us . Digg . Reddit . Slashdot . Facebook . StumbleUponSurround SCM reports use CSS stylesheets, which makes it easy to customize the look and feel of the reports. The stylesheets are stored in a StyleSheets subdirectory under the Surround SCM Server installation director. There are subdirectories for each type of report.
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If you haven’t discovered the list window enhancements added in TestTrack 2010.1, you definitely should check them out. There are a lot of time-saving improvements, including the ability to customize list window text appearance, shortcuts for working with subsets of items, and more available data.
Keep reading to learn more about the 2010.1 release enhancements, then watch the Working with TestTrack List Windows video for a tour of TestTrack list windows.
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