GxP for Life Sciences
Your organization handles sensitive data while protecting patient privacy, which means you need to meet stringent guidelines from regulatory bodies like the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global agencies.
See the ways we help you meet Good Practice (GxP) regulations.
Meeting Good Practice (GxP) regulations from the FDA is critical, as it helps ensure the safety, efficacy, and quality of pharmaceuticals, medical devices, and other healthcare products.
- Determining GxP readiness and data validation
- Implementing solid backup, contingency, and disaster recovery plans
- Developing change control and configuring management
- Implementing error handling and corrective measures
- Creating, enforcing, and validating SOPs and record-keeping using centralized document stores to meet GxP standards
Here’s how ClearDATA works for you:
Visibility Into Security
We enhance security and integration and build visibility:
- We give you a full view of our dashboard to simplify adherence to security safeguards for meeting GxP standards, providing 24x7x365 security monitoring and protection in AWS, Google, and Azure cloud environments, with PHI/PII discovery capabilities through our compliance and security dashboard in the CyberHealth™ platform, mapped directly to HIPAA, FDA, and GDPR guidelines.
- Our professional services team assists you in achieving interoperability, data exchange, and seamless integration between different systems.
- We provide client-side and server-side data encryption, encrypted data transfers, data integrity protections, access controls, continuous security monitoring and alerts, and incident management.
We operationalize compliance:
- We help you get and stay GxP compliant when operating in the cloud by automating and enforcing continuous compliance via our Policy-as-Code™ engine, which translates risk and security standards into technical controls and reference architectures.
- Our CyberHealth platform and services are compliant with leading frameworks, including HIPAA, HITRUST 9.5, GDPR, GxP, ISO27001, NIST, ITIL, CCSA, BAA, DPA, and SOC.
- Our CyberHealth™ platform offers automated compliance monitoring and remediation, audit controls, analytics, and visualizations, helping you to adhere to regulatory standards, and prioritize and track remediation activities.
We optimize data management:
- We provide a secure and reliable centralized document store for policies and procedures (SOPs) and compliance record-keeping, with high availability, scalable infrastructure, and disaster recovery capabilities.
- We offer data validation, quality controls, and data analytics to ensure you have access to reliable and accurate data for decision-making while providing robust data governance and monitoring.
- We help you streamline and reduce administrative inefficiencies through automation tools, workflow optimization, and data analytics to optimize operations.
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