Navigation Links
SureClinical Completes FDA 21 CFR Part 11 Compliance Audit of SureTrial® eTMF Cloud Edition
Date:8/1/2013

Rancho Cordova, CA (PRWEB) August 01, 2013

SureClinical, a provider of cloud-based content management application software and services for health sciences, announced today that it has successfully completed an FDA 21 CFR Part 11 compliance audit of its SureTrial® eTMF clinical trials content management application. More information is available at http://www.SureTrial.com.

Conducted through a leading independent GxP process auditing organization, SureTrial’s successful audit will help sponsors, clinical research organizations, academic research organizations and investigator sites running clinical trials comply with FDA rules and regulations related to electronic records and electronic signatures used in Electronic Trial Master File, or eTMF implementations.

“SureTrial eTMF is the first eTMF cloud software solution that completely addresses FDA 21 CFR Part 11 regulations and that has successfully completed an independent audit and validation,” said Zack Schmidt, President and CEO of SureClinical. “With the independent audit and validation of SureTrial eTMF, life sciences organizations can accelerate their compliance and validation initiatives for faster application deployment, insuring higher levels of GxP process management with eTMF documents and medical images.”

The FDA 21 CFR Part 11 compliance audit was performed by a leading independent GxP process organization that provides training to industry and US FDA regulatory agency personnel on 21 CFR Part 11 regulated computerized systems. The audit covered requirements for electronic records and electronic signatures under 21 CFR Part 11.

About SureClinical

SureClinical is a provider of cloud-based content management application software for health sciences. Headquartered in the Northern California, SureClinical’s founders have proven expertise in delivering market leading enterprise applications in the health sciences and enterprise mobile computing areas. To find out more, visit http://www.SureClinical.com.

###

Trademarks
SureClinical, SureTrial®, SureTrial® eTMF are trademarks of SureClinical.

Copyright © 2013 SureClinical. All rights reserved. SureClinical, SureTrial eTMF and the SureTrial logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.

http://www.SureClinical.com
http://www.SureTrial.com

Read the full story at http://www.prweb.com/releases/2013/8/prweb10982140.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Biocartis Completes EUR 71 Million (USD 100 Million) Series C Fund Raising
2. InnoPharma Completes $15 Million Series A Financing
3. Aratana Therapeutics Completes $15 Million Series B Financing
4. CeNeRx BioPharma Completes $4.85 Million Financing
5. PDL BioPharma Completes Regular Quarterly Dividend Payment
6. MiMedx Group Completes $5,000,000 Private Placement
7. goBalto Completes a Successful FDA 21 CFR Part 11 Compliance Audit
8. Auxogyn Completes $20 Million In Series A Funding
9. CitiusTech Completes Another Milestone Year: Revenues Grow by 59% in 2011
10. GeneLink Biosciences Completes Sale of GeneWize Life Sciences
11. Ikaria® Completes Patient Enrollment in Pivotal Phase III Trial for Bronchopulmonary Dysplasia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... June 27, 2016  Global demand for enzymes ... through 2020 to $7.2 billion.  This market includes ... cleaning products, biofuel production, animal feed, and other ... and biocatalysts). Food and beverages will remain the ... increasing consumption of products containing enzymes in developing ...
(Date:6/27/2016)... CA (PRWEB) , ... June 27, 2016 , ... ... for clinical trials, announced today the Clinical Reach Virtual Patient Encounter CONSULT ... care circle with the physician and clinical trial team. , Using the CONSULT module, ...
(Date:6/27/2016)... 27, 2016   Ginkgo Bioworks , a leading ... was today awarded as one of the World ... world,s most innovative companies. Ginkgo Bioworks is engineering ... real world in the nutrition, health and consumer ... with customers including Fortune 500 companies to design ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Researchers at ... most commonly-identified miRNAs in people with peritoneal or pleural mesothelioma. Their findings are the ... read it now. , Diagnostic biomarkers are signposts in the blood, lung fluid ...
Breaking Biology Technology:
(Date:6/16/2016)... 16, 2016 The global ... to reach USD 1.83 billion by 2024, according ... Inc. Technological proliferation and increasing demand in commercial ... to drive the market growth.      ... The development of advanced multimodal techniques for biometric ...
(Date:6/7/2016)... , June 7, 2016  Syngrafii Inc. ... a business relationship that includes integrating Syngrafii,s patented ... branch project. This collaboration will result in greater ... the credit union, while maintaining existing document workflow ... http://photos.prnewswire.com/prnh/20160606/375871LOGO ...
(Date:6/2/2016)... Perimeter Surveillance & Detection Systems, ... Infrastructure, Support & Other Service  The latest ... comprehensive analysis of the global Border Security market ... of $17.98 billion in 2016. Now: In ... in software and hardware technologies for advanced video surveillance. ...
Breaking Biology News(10 mins):