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Electronic Record Systems
FDA 21 CFR Part 11
The final version of the 21 CFR Part 11 regulation released by the FDA provides a framework in which organizations are able to sign, create, store and provide secure access to electronic records. 21 CFR Part 11 provides guidelines and rules related to copying, access and permissions, audit logs and tracking, version control, and the application of electronic signatures to electronic documents.
Compliance with 21 CFR Part 11 entails both procedural requirements and software requirements. The procedural requirements include validating the electronic records system, drafting and maintaining standard operating procedures for the use of the electronic records system, and ensuring that users of the electronic records system have adequate training about its appropriate use and administration.
EU Tissues and Cells Directive
Directive 2004/23/EC
Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
The EU Tissues and Cells Directive sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells intended for human application. It was adopted by the European Parliament on 7th April 2004. The Directive covers all human tissue except for:
- tissues and cells used as an autologous graft within the same surgical procedure,
- blood and blood components as defined by Directive 2002/98/EC and
- organs and parts of organs if the parts are to be used for the same purpose as an entire organ.
- The Directive does cover gametes (sperm and eggs) and embryos.
European Commission Regulation 37/2005/EC
The new European Commission Regulation 37/2005/EC on the monitoring of temperatures
in the means of transport, warehousing and storage of quick-
Another reason for establishing the new Decree is to eliminate legislative shortcomings
resulting from changes in the national legislation. By agreement with quick-
