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:10/12/2017)... ... October 12, 2017 , ... The Blavatnik ... Winners and six Finalists of the 2017 Blavatnik Regional Awards for Young Scientists. ... Foundation and administered by the New York Academy of Sciences to honor the ...
(Date:10/12/2017)... CA (PRWEB) , ... October ... ... (https://www.onramp.bio/ ) has launched Rosalind™, the first-ever genomics analysis platform specifically designed ... bioinformatics complexity. Named in honor of pioneering researcher Rosalind Franklin, who made ...
(Date:10/11/2017)... ... October 11, 2017 , ... ... today it will be hosting a Webinar titled, “Pathology is going digital. Is ... , on digital pathology adoption best practices and how Proscia improves lab economics ...
(Date:10/11/2017)... ... October 11, 2017 , ... Singh Biotechnology ... drug designation to SBT-100, its novel anti-STAT3 (Signal Transducer and Activator of Transcription ... is able to cross the cell membrane and bind intracellular STAT3 and inhibit ...
Breaking Biology Technology:
(Date:4/5/2017)... , April 4, 2017 KEY FINDINGS ... to expand at a CAGR of 25.76% during the ... is the primary factor for the growth of the ... https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The global stem ... technology, application, and geography. The stem cell market of ...
(Date:4/3/2017)... , April 3, 2017  Data captured ... engineering platform, detected a statistically significant association ... prior to treatment and objective response of ... potential to predict whether cancer patients will ... treatment, as well as to improve both pre-infusion ...
(Date:3/30/2017)... -- The research team of The Hong Kong Polytechnic ... by adopting ground breaking 3D fingerprint minutiae recovery and matching technology, ... accuracy for use in identification, crime investigation, immigration control, security of ... ... A research team led by Dr ...
Breaking Biology News(10 mins):