ExpeData® Demonstrates Commitment to Industry Clients With Ongoing 21 CFR Part 11 Compliance Initiative

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Market-leading EDW™ digital writing software platform solution meets stringent controls ensuring authenticity and confidentiality of data stored as electronic records.

I know of no other software product in any market with such a comprehensive set of features designed to promote security and usability.

ExpeData, a provider of digital writing solutions for multiple industries including pharmaceuticals and clinical research organizations, is pleased to announce that its EDW™ digital writing software platform solution has been rigorously evaluated and continues to meet the required security components of the United States Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 11.

21 CFR Part 11 deals with FDA regulations on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and generally equivalent to paper records. The regulation has three primary areas for compliance – infrastructure standard operating procedures (SOPs), product features, and validation documentation.

ExpeData’s EDW platform was audited by Computer System Validation, an FDA Compliance firm and one of the nation's foremost experts on Part 11. According to David Nettleton, President of Computer System Validation “Overall, the ExpeData EDW platform contains a complete set of security features and actually exceeds the current Part 11 industry standards. I know of no other software product in any market with such a comprehensive set of features designed to promote security and usability.”

Nettleton added, “The ExpeData EDW infrastructure SOPs show mature processes and commitment to quality standards. ExpeData meets the requirements for infrastructure SOPs related to FDA 21 CFR Part 11 compliance and has a sound ongoing compliance initiative.”

Commenting on the achievement, Paddy Padmanabhan, Chief Executive Officer, ExpeData said, “We are pleased to be recognized for our technology’s compliance to this important industry standard. These security features and requirements are applicable to all industries concerned about authenticity and confidentiality of electronic information.”

By meeting the requirements for Part 11, ExpeData’s EDW platform electronic output is considered reliable, trustworthy and generally equivalent to paper records. For enterprise users including those in highly demanding FDA-regulated industries, this translates to cost savings, operational efficiencies, and the assurance that data is complete, accurate, and secure.

"As a global leader in the emerging integrated digital writing market, ExpeData is leading the way to establish best practices for comprehensive software development and system validation life cycles including detailed validation documentation and mature processes,” said Padmanabhan. “Our rigorous and ongoing evaluation initiatives clearly show commitment to quality and regulatory compliance as well as a standard of excellence for digital writing solution delivery.”

ExpeData’s digital writing platform is the perfect solution to address data collection challenges in pharmaceutical clinical research organizations. Digital writing allows a user to provide information by writing on paper documents (such as case reports) with a digital pen.

The handwriting captured on the form is routed in near real-time using wireless mobile devices or PCs. Security of the data is ensured with encryption throughout the transmission process for protection of valuable information. The handwritten information is received by a digital writing server and converted into electronic data in industry standard formats and sent to downstream systems/databases for immediate use.

By incorporating digital writing into data collection processes, information exchange and communications are greatly expedited and enhanced. Research staff has access to information in near real-time. Problems can be identified and corrected before a protocol deviation becomes uncorrectable. This saves valuable time and money. Information is available to all parties participating in a study or trial at the same time for review and discussion, enhancing communication. User impacts are minimal as the experience for end users in terms of recording data is virtually unchanged.

Doug Patterson, Vice President of Business Development at ExpeData, who has worked with enterprise customers in the pharmaceutical/clinical research industry commented, “Using the ExpeData EDW digital writing platform enables adaptive clinical trials which provides a significant advantage in this highly competitive market. Patient outcome data can be used as it becomes available to adjust the trial and facilitate improvement of expected patient outcomes during the study period, while being able to reach sound statistical decisions in an expedited fashion. Adaptive procedures can offer significant time and cost advantages over standard clinical trial procedures.”

About ExpeData
ExpeData is an innovative software company and a global leader in digital writing. Our award-winning EDW™ products provide market-leading solutions for incorporating digital writing into existing business processes. Digital writing delivers significant benefits to organizations of all sizes. ExpeData EDW solutions are used across the globe, delivering value in multiple industries including Healthcare, Financial Services, and Field Services. For more information, visit http://www.expedata.net or call 877-341-EDWP (3397).

About Computer System Validation
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 192 mission critical laboratory, clinical, and manufacturing software implementation projects. For more information, visit http://www.computersystemvalidation.com/.

ExpeData, and marks shown with an ® are owned by ExpeData or their respective owners, and registered with the U.S. Patent and Trademark Office. Other trademarks, such as product and service names, found on ExpeData web sites are owned by ExpeData or by third parties. No ExpeData trademark or service mark may be used as a hyperlink or otherwise, including but not limited to, for advertising or promotion purposes, without ExpeData’s prior written permission. “Anoto”, “Magic Box” and the Anoto logotype are trademarks owned by Anoto AB.

For more information, contact:
Doug Patterson
ExpeData, LLC

Media Contact:
April J. D'Angelo
ExpeData, LLC


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