Is SiteCentric 21 CFR Part 11 compliant?
Yes. SiteCentric is fully compliant with 21 CFR Part 11, ensuring secure electronic records and signatures. We maintain detailed audit trails, enforce electronic signature protocols, and follow validation procedures to meet FDA requirements.
How does SiteCentric protect patient data?
We use end-to-end encryption for all data, whether it’s in transit or at rest. Access is tightly controlled through role-based permissions, and we continuously monitor for unauthorized activity or threats—ensuring patient privacy is always protected.
Does SiteCentric support HIPAA compliance?
Absolutely. Our platform is designed with HIPAA in mind and includes safeguards to protect personal health information. We help your site meet obligations for confidentiality, data integrity, and secure access.
Can we audit the system for compliance readiness?
Yes. SiteCentric supports both internal and external audits. Our system provides detailed logs, document histories, and eSignature tracking so you can demonstrate compliance to sponsors, CROs, and regulatory bodies with ease.
What happens if there’s a security incident?
In the rare event of a security issue, we have clear protocols in place for containment, investigation, notification, and resolution. Our team is trained and prepared to respond quickly—minimizing risk and ensuring transparency.
How often do you conduct security reviews?
We conduct regular internal audits and third-party assessments to ensure our infrastructure remains secure and up to date. Our team also undergoes ongoing security training to stay current with evolving threats and best practices.
Is my team trained on compliance and security practices?
Yes. As part of onboarding and ongoing support, we provide guidance and best practices to help your team navigate the platform securely and confidently—especially around sensitive workflows like document signing and patient data handling.
