Digital Pen Speeds Data Management, Helps FDA Compliance

Digital Pen Speeds Data Management, Helps FDA Compliance

April 14th, 2011 // 11:01 am @

Digital Pen Speeds Data Management, Helps FDA Compliance

Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around Anoto digital pen technology. It helps streamline all business processes that revolve around paper by quickly capturing free text handwriting from paper documents and converting it into electronic data. The technology is best described by breaking it down into four areas: write, transmit or interpret, validate, and integrate.

Write

The first component of the technology is the paper that each document is printed on. The paper is nothing more than regular plain white sheets you can buy at any office supply store; the difference is the actual printing of the documents. The first step is for Hyla Soft to recreate the existing documents so they can be used with FactoryScribe. Every document is printed with the original content but with a background that contains a unique dot matrix pattern. This matrix gives the paper a grayish tint and is barely visible to the naked eye. The matrix acts like an x-y coordinate plane to interpret the handwriting and to let the pen know the exact location on the page (e.g., text box, bubble, check box), and on what specific document a user is writing. As a user writes, the pen captures 70 pictures per second. The pen has the ability to hold up to 200 pages of data before a transfer is needed.

When users need to work with a specific document, they can go to the Factory Scribe web portal, select the desired report to use, and print it. Then they begin writing on the document as they would with a regular pen.

Transmit or interpret

Once the document is complete or the pen’s memory is full, the data need to be transferred. This can be done via Bluetooth or a USB docking station. Using Bluetooth, the pen can transfer the data to a smart phone, and the smart phone can forward the information to FactoryScribe’s web application. If the pen is docked in a USB station, the information is also automatically sent to FactoryScribe.

Data are stored in FactoryScribe’s database, where the document’s text is interpreted by the system and converted to digital text. The completed document is saved in a PDF format. Because the PDF is stored electronically, the original file can be discarded.

Validate

Once the information has been transferred and converted into digital text, each text area on a document can have its own tolerance for accuracy. This is set up when the document’s template is created. For example, if a lab technician is taking measurements that must be filled out and recorded for compliance reasons, then every area on the page where she would record that information could have a 95-percent tolerance. This means if FactoryScribe is not 95-percent sure it has interpreted the handwriting correctly, the document will be flagged. Flagged documents require additional validation. To do so, a user can log in to the FactoryScribe system and view documents that need further validation. When a user is validating the flagged documents, FactoryScribe shows her which fields need further verification and displays an image of the recorded handwriting for that text area. When all text areas in question have been reviewed, a user can submit the document with changes.
Integrate

If a submitted document does not have any questionable data fields or has been validated by a user, it can be sent to a third-party system. By taking advantage of XML, FactoryScribe can be set up to export data to other systems such as SAP or Oracle.

The advantages of digital pen and paper include:

Improved operational visibility. Data availability changes from weeks of lag time to minutes or even seconds. More informed decisions can be made quicker, with real-time data.
Eliminate data entry, better compliance. Teams save time and the costs of manual data entry. Misplaced paperwork does not mean lost data; all digital copies are immediately archived with time, date, and author stamps as well as signatures.
Easy to use. Users don’t need to learn anything new as they do with laptop or tablet PC-based applications. They simply use the same system they’ve always used: pen and paper.
Bring products to market faster

The lab arena is one environment that could benefit from the FactoryScribe solution. Countless procedures done in labs are recorded on paper and then later stored or entered in laboratory information management systems (LIMS)—everything from quality tests to new product development. The time that it takes a lab technician to manage these data, including organizing them, manually transferring them from paper to a computer, and storing them, could be spent doing actual testing and providing product improvement and development.

With FactoryScribe, lab technicians no longer have to worry about data management and manual data entry. As technicians write with the pen, on regular paper, their handwriting is saved to the pen’s memory. The pen can record and save information from multiple documents, so technicians can switch between forms as needed. Once complete, a digital copy of the document can be transferred via Bluetooth or docking station to FactoryScribes database. From there the PDF files can be automatically managed and the handwriting extracted and converted to computer text. Once the data have been converted to computer text an interface allows seamless integration to another system such as a LIMS.

FactoryScribe can be validated so that it complies with the U.S. Food and Drug Administration’s guidance on electronic records and electronic signatures, 21 CFR Part 11.

For more information, visit the FactoryScribe website.

 


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