Businesses under the purview of FDA need to comply with 21 CFR Part 11 guidelines. In this article, we summarized and simplified the assessment of Minitab statistical software's compliance with respect to the FDA requirements.
Source: https://www.minitab.com/en-us/support/compliance/
Let's dive into how Minitab Statistical Software aligns with these crucial standards and how we at Factonity can help bridge any compliance gaps.
Requirements of 21 CFR Part 11
- Validation of Electronic Systems: Ensure accuracy, reliability, and consistent performance of electronic systems used in regulated processes.
- Electronic Signatures: Establish procedures to ensure electronic signatures are trustworthy, authentic, and legally binding.
- Access Controls: Implement controls to limit system access to authorised individuals and ensure security.
- Audit Trails: Create and maintain audit trails capturing changes to records, including user identification, date, time, and nature of changes.
- Data Integrity: Implement measures to ensure the integrity, security, and authenticity of electronic records throughout their lifecycle.
- Documentation and Policies: Develop and maintain written procedures, controls, and policies for electronic records and signatures.
- Training and Education: Provide adequate training to personnel using electronic systems regarding their responsibilities and procedures.
- Retention and Retrieval: Establish systems for the secure retention and timely retrieval of electronic records as required.
These requirements aim to ensure the reliability, security, and authenticity of electronic records and signatures in regulated industries, emphasising the need for controls, documentation, and validation throughout the electronic record lifecycle.
Minitab statistical Software vs FDA 21 CFR Part 11 key requirements
| Requirement | Compliance by Minitab Statistical Software | Explanation/Commentary |
|---|---|---|
| Validation of Systems | Facilitates compliance | Minitab provides a validation kit. The act of validation is required to be done by customers themselves or 3rd party service providers like us. |
| Electronic Signatures | Not applicable | Minitab doesn't handle electronic signatures. |
| Access Control | Partially compliant | Minitab generates project files that "can" optionally be password protected. However the password on the file are file specific, not user specific. That means users need to share the passwords to be able to use the password protection feature. |
| Audit Trails | Not available | Audit trail features are not available. 3rd party systems might be required for audit trail capabilities. |
| Data Integrity | Partially compliant | Passwords secure files, but broader data integrity is needed. |
| Documentation & Policies | Not applicable | Minitab provides guidelines but not specific documentation. |
| Training & Education | Not applicable | Minitab doesn’t offer compliance training. |
| Retention & Retrieval | Partially compliant | Passwords aid retention, but broader measures aren't detailed. |
Sharing Responsibility for Compliance
As per Minitab's webpage on compliance, while Minitab offers some compliance features, it's ultimately the customer's responsibility to validate processes, follow guidelines, and set up broader controls.
Conclusion
Minitab Statistical Software provides file level password protection, which partially helps meet FDA's 21 CFR Part 11 guidelines, however that is NOT sufficient to claim 100% compliance. External / 3rd party solutions might help improve compliance.
How to improve compliance?
At Factonity, we specialise not only in statistical softwares like Minitab, but also assist regulated industries in meting their validation and compliance requirements. Contact us to explore how we can assist you with additional features / software systems for CFR Part 11 compliance.