21 CFR Part 11 Compliance
Rcube Analytics systems employed in clinical trials are maintained in a controlled and validated environment which is 21 CFR Part 11 compliant through a combination of technical and procedural controls. This is accomplished through the following:
- 1. Systems development following a standard, industry-accepted validation lifecycle methodology to ensure systems function in an expected, consistent and accurate manner.
- 2. Involvement of People
- 3. Utilization of current security technologies and procedures to ensure system/network security and data protection, and controlling of access to sensitive data and applications which modify the data.
- 4. Application of audit trails to ensure accurate capture of operator entries that create, modify, or delete electronic records.
- 5. Establishment of policies and standard operating procedures to ensure control of development, deployment, maintenance, and use of computerized systems.