Streamline Regulatory Compliance with GenRAC from genbioca
The Regulatory Compliance Tool, GenRAC, is an innovative platform designed to streamline, automate, and enforce compliance processes for pharmaceutical and life sciences clients, healthcare industries, clinical research centers, and contract research organizations. Operating under some of the most stringent regulatory environments, these industries demand a solution that ensures First Time Right (FTR) compliance. GenRAC minimizes non-compliance risks and provides a Systematic Compliance Approach to optimize resource allocation, reduce audit preparation time, and maintain the highest standards across documentation, quality, and regulatory adherence.
- Minimize Risk: Adhere to regulatory standards such as GDPR, 21 CFR Part 11, SOC2, FHIR, HIPAA, and ISO 13485, mitigating financial, legal, and reputational risks associated with non-compliance.
- Enhance Efficiency: Automate checklist-based compliance, manage Corrective and Preventive Actions (CAPA), and utilize advanced audit tools to support seamless compliance operations.
- Integrated Capabilities: Leverage gap analysis, compliance tracking, audit management, and reporting to ensure adherence to both internal and external regulatory requirements.
- Efficiency: Reduce time spent on manual compliance processes.
- Accuracy: Ensure First Time Right (FTR) compliance across tasks.
- Scalability: Adaptable to meet evolving regulatory landscapes and organizational needs.
- Comprehensive Reporting: Generate detailed compliance reports for internal use and external audits.
- User-Friendly Interface: Simplify navigation and enhance user experience with intuitive design.
- Identify compliance process gaps to align with the mandatory requirements of regulatory agencies and industry best practices.
- Provide actionable insights to bridge compliance gaps efficiently.
- Corrective and Preventive Actions (CAPA)
- Track and manage CAPA for issues identified during audits, ensuring continuous improvement.
- Automate workflows to resolve compliance issues promptly.
- Audit Management
- Support for internal, external, and surveillance audits.
- Real-time compliance tracking and automated audit documentation.
- Regulatory Filings
- Simplify and streamline NDA/ANDA and e-CTD submissions.
- Ensure documentation accuracy and compliance with regulatory body requirements.
Who Can Benefit
- Pharmaceutical and Life Sciences Companies
- Healthcare Industries
- Clinical Research Centres
- Contract Research Organizations (CROs)
Why Choose GenRAC?
GenRAC is developed by genbioca, leveraging years of expertise in regulatory compliance for highly regulated industries. With a focus on innovation and excellence, GenRAC provides:
- A robust platform to minimize compliance risks.
- A strategic approach to optimize regulatory operations.
- Tools to ensure adherence to the highest standards of quality and safety.
GenRAC – Your Partner in Compliance Excellence
Contact us for more information about GenRAC and how it can transform your compliance processes, visit www.genbioca.com or contact our team at gbc@genbioca.com