Manage compliance in line with regulatory requirements, with instant access to each patient's electronic audit log. TrakCel's implicit orchestration, traceability and reporting capabilities allow you to proactively manage and meet quality requirements far more effectively and efficiently than paper-based best efforts.
This is a subset of the regulations and statutory obligations that the TrakCel platform is designed to meet. Additionally we provide support during the requirements gathering and validation project phases. Our experts will perform regulatory reviews and science-based risk assessments to ensure you remain compliant. Our validation processes are based on FDA and PIC/S guidance.
Good Manufacturing Practice (GMP)
- FDA 21 CFR Part 11 (and predicate rules)
- EudraLex Volume 4 Annex 11
- EudraLex Volume 4 Chapter 4
EU Tissue and Cells Directives
- Directive 2004/23/EC
- Directive 2006/17/EC
- Directive 2006/86/EC
Good Clinical Practice
– MHRA Good Clinical Practice Guide
PII (Personally Identifiable Information)
– HIPAA - Health Insurance Portability and Accountability Act