21 CFR Part 11
Ensuring Part 11 Compliance in GxP Environments
When 21 CFR Part 11 was released in 1997, it was hailed as a landmark regulation that finally made electronic records and signatures as valid as paper records and handwritten signatures. It allows the use of electronic record-keeping systems in complying with regulations. Part 11 (also known as "Electronic Records; Electronic Signatures" or ERES) works in tandem with a predicate rule, which refers to any FDA regulation that requires organizations to maintain records.
In 1998, MasterControl Inc. introduced the first document control software especially designed to help the life sciences industry comply with Part 11. Since then, hundreds of companies worldwide have been using the MasterControl™ quality management suite — an integrated, configurable, off-the-shelf, and easy-to-use software solution — to comply with various FDA regulations. Here are highlights of MasterControl features that address Part 11 requirements:
| 21 CFR Part 11 Requirements |
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MasterControl Features |
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( Part 11 Section 11.10 )
Ensure authenticity, integrity, and when appropriate confidentiality of electronic records.
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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.
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( Part 11 Section 11.10 )
Minimize possibility of repudiation by signer.
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MasterControl 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.
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( Part 11 Section 11.10 a )
Validate the system.
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MasterControl 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.
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( Part 11 Section 11.10 i )
Determination that persons using the electronic system have been properly trained to perform their assigned tasks.
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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.
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( Part 11 Section 11.10 k )
Appropriate controls over system documentation including access to documentation for system operation and revision and change control procedures that documents time-based system modification.
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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.
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( Part 11 Section 11.50 a )
Signed electronic records must contain: name, date/time of signing, and meaning of signature.
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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.
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( Part 11 Section 11.70 )
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records.
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Every signature is linked to a specific record. The signature information cannot be tampered with after approval.
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MasterControl is compliant, helping you meet 21 CFR Part 11 and other FDA regulations year after year, while keeping compliance costs down.
MasterControl is connected, giving you the ability to monitor the entire quality system and continuously improve it.
MasterControl is complete, meeting every department's needs to ensure that quality initiatives are enforced across the enterprise.
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Creating a Paperless Process Using MasterControl
