Navigate 21 CFR Part 11 Confidently with Confience LIMS

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Laboratory Information Management System (LIMS) software is an essential tool for adhering to Title 21 CFR Part 11 of the Code of Federal Regulations — guidelines set by the U.S. Food and Drug Administration (FDA) concerning electronic records and signatures. As laboratories shift to digital systems for enhanced workflow efficiency, compliance with these regulations becomes of paramount importance. LIMS support the shift from paper to computerized systems by offering a reliable solution that safeguards the integrity, confidentiality, and accuracy of electronic data at every stage of its lifecycle.

‍Facilitating Data Integrity and Security:

FDA regulation 21 CFR Part 11 requires that electronic records must be as trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Laboratory information management system software helps laboratories generate and maintain audit-ready electronic records by incorporating user authentication, access controls, electronic signatures, and comprehensive audit trails.

Authentication and Authorization:

FDA regulation emphasizes the use of Electronic Signatures that are unique to each user. LIMS typically incorporate stringent access controls that authenticate user identities through secure login mechanisms. By configuring permissions and roles appropriately within the laboratory information management system software, laboratories can ensure that only authorized personnel have access to sensitive data and functions, thereby adhering to the principle of least privilege as recommended by 21 CFR Part 11. 

Electronic Signatures:

Confience LIMS software complies with the FDA code of federal regulations 21 CFR Part 11 requirement for Electronic Signatures with its Electronic Signature software. The Electronic Signature module provides additional password prompted functionality for the validation, approval, and certification of data. There are up to four (4) levels of Electronic Signature approval that users can define via an Electronic Signature matrix. The Electronic Signatures module allows the administrator to define what transactions require Electronic Signatures, including:

• Sample identification and/or update

• Entry and/or modification of results

• Entry and/or approval of test methods

• Entry and/or approval of product specifications

• Assignment of release status of samples

Audit Trails:

Comprehensive audit trails are integrated within the LIMS and configurable to allow automatic recording of the date and time of entries, modifications, or deletions of information, and to identify the user responsible for these actions.  

The audit trail records WHAT was changed (the field and table that was modified), WHEN the change was made (the time and date), WHO made the change (the user name of person logged at the time of change), WHY it was changed wherever it is practical to do so (the reason for modification) and the PREVIOUS VALUE. Based on user configuration, audit trails can be applied to any of the tables within a LIMS and will record each change that is made to any or all records in the system on a field-by-field basis.

In most cases the audit trail information is best displayed using a report; however, there are some situations where instantaneous presentation of the audit trail is desirable. Audit trails are most frequently referenced with respect to the results that were entered and subsequently overwritten with a modified value. When quick access to audit trail records is desired, LIMS users with appropriate permission can view a Result or Sample Audit Trail directly from the LIMS lab system toolbar.

Audit Trails are exceptionally useful tools because they allow users to track down problems that may arise whenever data is modified intentionally, maliciously or in error. Comprehensive audit trail functionality in LIMS not only promotes transparency but provides an indelible record that is crucial during audits or inspections.

Data Backup and Storage:

Ensuring the safety and recovery of electronic records is another requirement under FDA regulation 21 CFR Part 11. LIMS often include automated data backup functionality, and LIMS vendors may provide secure data storage solutions that protect against data loss and facilitate easy recovery in the event of a system failure. This not only supports compliance but enhances the overall resilience of laboratory operations.

System Validation:

To be suitable for use in regulated industries the operation of the system must be validated. Validation of systems to ensure accuracy, reliability, and consistent intended performance is a critical step in highly regulated environments to ensure data integrity and prove compliance. LIMS vendors may offer validation services and documentation as an option for companies where this is a necessity to ensure that the system conforms to the established requirements and can handle the designated tasks. This can be time consuming and costly, so organizations in regulated environments will need to determine how thorough their validation of the LIMS needs to be, prior to beginning the process.  

Steps to LIMS Validation may include: 1) Development of a User Requirements Specification (URS) and a matching Functional Specification (FS), 2) Risk Assessment, 3) Installation Qualification (IQ), 4) Operation Qualification (OQ) and 5) Performance Qualification (PQ). Evidence of validation must be rigorously documented to satisfy regulatory authorities.

Conclusion:

In summary, LIMS are indispensable tools for laboratories seeking to comply with 21 CFR Part 11. By offering sophisticated functionality for User Authentication, Electronic Signatures, Audit Trails, Data Preservation and System Validation, LIMS help laboratories meet the stringent standards set forth by the FDA for electronic documentation and record-keeping. As regulatory requirements evolve and technology advances, continuing upgrades and enhancements to LIMS will be vital in maintaining compliance and supporting the integrity and security of LIMS lab systems.

Confience delivers automated lab management and data you can act on, for trusted products and a thriving planet. Want to learn more about Confience? Request a demo at www.confience.io.