If you're familiar with 21 CFR Part 11 documentation, you're likely acquainted with compliance audits, electronic record integrity and approval processes. However, you may wonder what the term "readily available" means or what "instantly" refers to in the same context. According to Labcompliance News1, it's these phrases that keep regulated companies guessing.
Following the completion of a 483 inspection, FDA inspectors provided some context to these phrases by clarifying what it means to NOT have documentation that is readily available.
21 CFR Part 11 requires that electronic records be "instantly" retrievable, and inspectors expect documentation to be "readily" available for inspection.
In the 483 inspection, inspectors requested 20 types of documentation. To establish a timeframe for the request, the 483 included the dates of when the documents were requested and when they were made available. When the requested documentation was provided, the inspector found it to be unorganized and incomplete. When this occurred, the inspector essentially deemed the documentation not readily available for authorized inspection.
The organization, completeness and accessibility of documentation is critical for maintaining compliance in any regulated environment. The advent of 21 CFR Part 11 means that the FDA's main concern with electronic records is to preserve record integrity in order to ensure product quality.
In 1998, MasterControl became the first Quality Management System (QMS) software provider to release a solution that specifically addressed FDA 21 CFR Part 11 regulations.
MasterControl provides all the necessary software components, installation and configuration assistance, training and support to become fully compliant with 21 CFR Part 11. In concert with MasterControl solutions, organizations should develop internal policies for user ID and password confidentiality, controls over system documentation and verification of users' identity before allowing access to the system and records.
Inefficient documentation processes are the biggest detriment to FDA compliance.
MasterControl protects all electronic records through its comprehensive permission system and unique storage technology. Based on privileges, users can utilize MasterControl search tools to immediately retrieve records that have been identified as permissible.
Part 11 regulations cite that organizations need the ability to perform authority checks of users, check system usage and detect invalid or altered records. Audit trails are useful for this purpose–especially when users are expected to create, modify, or delete regulated records.
The ability to input data into MasterControl is a "rights-based" privilege. Any time a record is created, the user's ID and information are captured in the audit trail. Any changes made to a record or record metadata are time- and date-stamped and captured in the audit trail using a field titled "Reason for Change."
21 CFR Part 11 requires companies to establish and follow written policies against falsification of records under their electronic signature. It's also important to minimize the possibility that a signer would repudiate an approval.
MasterControl requires users to enter two passwords to approve any type of document collaboration. The first password is the login password and the second password is an "approval" password. In order to sign-off on any record, users must use a different approval password that is unique to the individual user.
To prevent users from falsifying electronic signatures, MasterControl does not allow system administrators or any single user to change signature credentials alone.
Ultimately, your company's goal should be to have documentation that consistently stands up to scrutiny, not just during inspections. With the help of MasterControl, you can strengthen your Part 11 compliance by keeping your documentation and processes inspection-ready.
1. FDA Inspection Clarifies what "Readily Available Documentation" Means