Logging matters in regulated environment.

The pharmaceutical industry is a Food and Drug Administration-regulated industry that is required to track processes and procedures using detailed log books. Many companies opt to use paper log books that are difficult to maintain, require lots of physical storage space, and are nearly impossible to query for valuable information. A pharmaceutical company wanted to digitize its log books and, after searching for an off-the-shelf solution to no avail, approached Matrix Technologies’ pharmaceutical engineering consultants to help.

Thinking Digitally

Matrix Technologies worked closely with the pharmaceutical client to develop a web-based application to digitize its paper log books while handling all of its specific business requirements. By using a web browser as the middleware, end users can access the website and make log book entries using any desktop, tablet or mobile device connected to the system.

Electronic Logbook

The application is built on proven Microsoft technologies including ASP and the .NET Framework in addition to HTML5, CSS, and JavaScript to render the responsive design. The system requires minimal maintenance and allows users to quickly print reports for compliance checking.

The electronic logging application also features:

  • Customizable navigation tree
  • Filtering of log books
  • User favorites
  • Custom workflows by log book type
  • Signature and timestamp recording for all activities
  • Configurable second- and third-level signature requirements
  • Context based entries associated to time, batches and campaigns
  • Printable report generation for each log book type
  • Administrative graphical user interface (GUI) for creating, renaming and archiving log books as well as managing the navigation tree and its links

Conclusion

Digitization is providing manufacturers with cutting edge tools and real time data while reducing storage, enhancing archival abilities and increasing operational efficiency, especially in regulated environments.  Matrix Technologies’ ability to build custom, enterprise-ready applications is helping our clients solve even the most difficult business problems. Our application development capabilities extend well beyond software integration, with a dedicated staff of experienced developers with proven capabilities.

If you are interested in the electronic logging application, need to develop a custom software solution or want to explore integration between systems, feel free to contact Matrix Technologies’ pharmaceutical engineering consultants.

Matrix Technologies is one of the largest independent process design, industrial automation engineering, and manufacturing operations management companies in North America. To learn more about our manufacturing operations management capabilities and manufacturing process control solutions, contact John Lee, Strategic Manager of Manufacturing Intelligence.

© Matrix Technologies, Inc.

Tags: / Food and Drug Administration / Industrial Automation Engineering / Manufacturing Operations Management / Manufacturing Process Control / Software Engineering /

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Biotech / Pharmaceutical – Manufacturing Intelligence

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