21 CFR Part 11 Section

Regulation Summary

MasterControl Feature

11.10

Ensure authenticity, integrity, and when appropriate, confidentiality of electronic records

MasterControl provides a system administration feature that defines permissions for each user and for electronic records in the system. There are more than 100 permissions available in MasterControl and are assigned at the administrator level.
System administrators have all permissions and are able to restrict user access to records as is necessary and appropriate. Actions taken against any record in the MasterControl system are captured in the MasterControl audit trail.

11.10

Minimize possibility of repudiation by signer

MasterControl has numerous levels of security to ensure the authenticity of each user in the system. Each user has a unique user ID and login password that the user uses to gain access to the system. Additionally, in order to sign off on any record, they must use a different “approval” password unique to this individual user. All user IDs and passwords are encrypted for security.

11.10 (a)

Validate the system and ensure ability to detect invalid or altered records

MasterControl offers an exhaustive set of IQ, OQ, and PQ test protocols to assist customers with software validation. Updated protocols are provided with each and every system build and revision.
Changes that are made to a record or record metadata are captured in the audit trail with a field provided for “reason for change.”