ExpeData Demonstrates Commitment To Industry Clients With Ongoing 21 CFR Part 11 Compliance Initiative
July 22, 2010
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."
ExpeData's digital writing platform is the perfect solution to address data collection challenges in pharmaceutical clinical research organizations. 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."
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 .
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/.