Cloud Compliance Portal
In the highly regulated drug development market, certain software applications used in the clinical trial process must comply with and be validated against a growing list of global government requirements. US and EU requirements such as FDA 21 CFR Part 11, HIPAA, European Commission Directives and US FDA electronic signing regulations make it costly, time consuming and difficult for organizations to monitor a vendor’s adherance to changing regulatory compliance requirements.
To address our customer’s ongoing compliance needs, to minimize risk, accelerate system deployment timelines and to reduce validation and compliance costs, SureClinical launched SureCompliance™. Accessed through a continuously updated web portal as an annual subscription service, SureCompliance is designed to give our life science and healthcare customers immediate access to the critical system compliance documents that they need for regulatory audits and inspections. The SureCompliance service also includes a training and test environment for quality and training purposes.
SureClinical maintains its compliance documents including SOP’s, data center independent audit opinions, independent compliance opinions for our applications, platform and network, staff training records, validation test scripts, validation reports and many more compliance documents. To ensure audit readiness, our compliance documents are updated continuously against an ever changing matrix of global regulatory agency requirements.
Accelerate System Validation and Deployment
SureCompliance is an annual subscription service providing you with an online portal that addresses FDA, EC and other regulatory agency requirements for validation of health science applications. It includes features such as:
Compliance Web Portal: SureClinical has delivered its compliance validation documents and reports to meet the requirements of FDA 21 CFR Part 11, EC Annex 11 and GAMP 5.
Test Environment / Instance: SureClinical provides a test instance with a non-production software license and snapshots of your data (reimaged at major releases).
Pre-release Access to software and test results: To assist its customers with system compliance tasks, SureClinical provides its SureCompliance subscription customers with access to tested, pre-release versions of software, as well as test reports and requirements approximately 4-6 weeks prior to major releases.
Audit trail: All user activity on the SureCompliance portal is tracked with a read-only time-stamped audit trail that adheres to FDA requirements for user activity and login events.
Continuous updates: Proactive compliance portal content monitoring and updates means that you’ll have the most current system compliance information on your compliance portal subscription, 24×7.
Time and Cost Savings, Minimize Risk
Accelerated Validation Enhances Productivity through reduced system deployment time and labor costs. Satisfy vendor and quality audit requirements with access to web based compliance docs.
Save Money and Time on Compliance Validation – While other vendors charge hundreds of thousands in validation fees and months and months of validation services, SureCompliance can save you time and money with FDA accepted validation documents, test results and more, online and available instantly.
Minimize Risk with on demand access to compliance docs – Get access to system validation documents when you need them most – even in the middle of an inspection or audit.
Save staff time and hassle collecting compliance certificates, records and docs.
Save money and travel costs with on-site audits – complete audits remotely using the SureCompliance Portal.
Certifications and Compliance Documents
The SureCompliance subscription service and portal provides customers with a comprehensive list of certifications and compliance docs. Designed for use in areas such as vendor qualification, validation, audits and other tasks by quality teams, these documents are continuously maintained by SureClinical for our clients. Example of some of our compliance certifications and quality docs:
Staff Training Records: Continuous training on SOP’s and processes, evidenced by digitally signed training records and reports.
Software Release Test Reports: Detailed reports on test case results for automated and manual tests.
Software Release Test Cases: Detailed step-by-step test cases for software features with screenshots of expected results. (additional fees may apply to license these test cases)
SOP documents: Current SOP documents related to the development, operation, maintenance support, testing of software, cloud operations, security, and more.
Vendor Qualification: Vendor qualification analysis and reports.
Independent Validation Certificates: Opinion letters and certifications for compliance validation of data centers, applications for applicable areas.
SOC 1, SOC 2, SOC 3 Compliance: Support for all major AICPA SOC Data Center compliance certifications with independent audit opinion letters continually updated.
SSAE-16 Type I and Type II Attestation: Support for both SSAE-16 Type I and Type II attestations in conjunction with auditor SSAE 16 Solutions.
HIPAA Business Associate: SureClinical maintains policies and procedures necessary to act as a HIPAA Business Associate for customers whose application maintains data covered by HIPAA regulations.
FDA CFR Part 11 Application Certification: SureClinical’s cloud applications are independently audited and validated through an ongoing program of continuous validation and certification. These in-depth evaluations of our cloud applications and cloud infrastructure are done against a rigorous set of FDA regulations.
U.S. Commerce Department Safe Harbor Certification: SureClinical’s cloud is certified under the U.S Commerce Department’s Safe Harbor program, which signifies that the SureClinical cloud employs policies and procedures that meet the privacy standards of the European Commission’s Directive on Data Protection. By certifying under the program, SureClinical’s customers can be assured that their personal information is private and protected.
FIPS-140-2 Level 3 compliance: SureClinical’s Certified Cloud is the first cloud solution for health sciences to offer a secure cloud-based digital signing service that enables investigators to electronically sign documents outside the firewall making the 100% paperless eClinical system a physical reality. Our patent-pending signing services support digital certificate signing (PKI x.509). All PKI signing transactions utilize US NIST tested and approved FIPS-140-2 Level 3 technologies.