FDA 21 CFR Part 11 software systems meet the complex regulations that provides criteria for acceptance by the FDA of electronic records and signatures as equivalent to paper records and handwritten signatures. The regulation, which applies to all FDA program areas, is meant to permit the widest possible use of software technology. The use of software for electronic records for submission to FDA is voluntary.
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In 1998, MasterControl Inc. introduced the first FDA 21 CFR Part 11 software systems especially designed to help the life sciences industry comply with 21 CFR Part 11. Since then, hundreds of companies worldwide have been using the MasterControl quality management suite â€” an integrated, configurable, off-the-shelf, and easy-to-use software solutions to comply with various FDA regulations.
21 CFR Part 11 System Requirements
MasterControl 21 CFR Part 11 Software Features
21 CFR Part 11 Section 11.10
Ensure authenticity, integrity, and when appropriate confidentiality of electronic records.
MasterControl lets the system administrator define permissions for each user and every vault in the system. There are more than 90 permissions available in MasterControl. Administrators have all permissions and may restrict user access to vaults and documents as necessary. All actions made on any document are captured in the MasterControl audit trail.
21 CFR Part 11 Section 11.10
Minimize possibility of repudiation by signer.
MasterControl's FDA 21 CFR Part 11 software has numerous levels of security to ensure authenticity of each user in the system. Each user establishes a login password upon first entering the system. To sign off on any document, the user must use a different "approval" password. All user ID's and passwords are encrypted for security.
21 CFR Part 11 Section 11.10 a
MasterControl helps in validating our FDA 21 CFR Part 11 compliant systems.
MasterControl's FDA 21 CFR Part 11 software provides comprehensive validation services, including onsite IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) tests to ensure that the system is fully compliant. For companies wanting to perform their own validation, MasterControl offers a Validation ToolKit, which provides a detailed, pre-written validation test protocols and scripts.
21 CFR Part 11 Section 11.10 i
Determination that persons using the electronic system have been properly trained to perform their assigned tasks.
MasterControl provides comprehensive product training program. Training courses are given for each level of user to ensure that every user can perform assigned tasks within the MasterControl system.
21 CFR Part 11 Section 11.10 k
Appropriate controls over system documentation including access to documentation for FDA 21 CFR Part 11 system operation and revision and change control procedures that documents time-based system modification.
MasterControl is a closed system that requires an ID and password to access any information. This information is controlled by privilege. MasterControl also comes with built in revision and change control capabilities.
21 CFR Part 11 Section 11.50 a
Signed electronic records must contain: name, date/time of signing, and meaning of signature.
All records signed electronically capture the username, time/date and meaning of signature. Additional information can also be included at set-up, such as vault designation. Signature information is on the document whether viewed on a user's PC or when printed.
Part 11 Section 11.70
FDA 21 CFR Part 11 software has an electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records.
Every signature is linked to a specific record. The signature information cannot be tampered with after approval.