TRI Quality Assurance team reviews your compliance with all 21 CFR titles, including regulations on the protection of human subjects, IRBs, GMPs, GLPs and non-clinical laboratory practices, IDN application, and financial disclosures. We monitor proper compliance with many other relevant regulations, and provide the right tools and strategies to successfully manage and undergo FDA inspections and ISO certifications.
Our QA experts specialize in confirming compliance with 21 CFR 11 by ensuring that the systems used to create, store, modify, maintain, and transmit your electronic records, exhibit first-class security, reliability, traceability, and accountability features. We also ensure compliance with human subject protection regulations (21 CFR, 50, 45 CFR 46, etc) to guarantee protection of human subjects by inspecting informed consent procedures, and IRBs operations, records, and reviews for instance.
Prior to an FDA inspection, we increase your responsiveness and performance by designing a detailed roadmap of the visit, organizing regulatory documents (e.g. IRB correspondence, protocol, investigational product records, CRFs), organizing teams and defining roles (i.e. host, runner, scribe, and backroom reviewers), and informing employees on procedures and appropriate behaviors.
Finally, we ensure your management systems’ adherence to a broad variety of ISO standards such as ISO 9001:2008, ISO 14001:2004, and ISO/IEC 27001, and guide you through the implementation of their rigorous mechanisms for successful completion of ISO certifications.
- Compliance Services
- 21 CFR and 45 CFR 46
- 21 CFR Part 11
- ISO Certification Readiness
- FDA Inspection Readiness
- FDA Enforcement Action Support