Compliance

21 CFR Part 11 Compliance

Everest 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:

  • Systems development following a standard, industry-accepted validation lifecycle methodology to ensure systems function in an expected, consistent and accurate manner.

  • 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.

  • Application of audit trails to ensure accurate capture of operator entries that create, modify, or delete electronic records.

  • Establishment of policies and standard operating procedures to ensure control of development, deployment, maintenance, and use of computerized systems.

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