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. 1. Systems development following a standard, industry-accepted validation lifecycle methodology to ensure systems function in an expected, consistent and accurate manner.
  2. 2. Involvement of People
  3. 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. 4. Application of audit trails to ensure accurate capture of operator entries that create, modify, or delete electronic records.
  5. 5. Establishment of policies and standard operating procedures to ensure control of development, deployment, maintenance, and use of computerized systems.