Tracking and documenting Good Manufacturing Practice (GMP) compliance can feel like a heavy lift. That’s why most life sciences organizations use digital tools like a computerized maintenance management system, or CMMS, to monitor maintenance and calibration workflows.
Both the United States and the European Union have strict guidelines for the use of computerized systems (like a CMMS) in GMP compliance. We’ll explain what your obligations are under both the EU’s GMP Annex 11 and the FDA’s CFR Part 11. We’ll also talk about the challenges in both regulatory systems and how to overcome them.
What Is the FDA 21 CFR Part 11?
The US Food and Drug Administration’s (FDA) regulations concerning food and drugs are set out in Title 21 of the Code of Federal Regulations, usually called 21 CFR. 21 CFR Part 11 lays out the guidelines for electronic record keeping and signatures used to demonstrate regulatory compliance.
The purpose of Part 11 is to ensure that electronic records and signatures are authentic, accurate, and confidential. The underlying principle is that electronic compliance documentation should be as reliable and secure as paper records.
What Are Part 11’s Guidelines for the Use of CMMS in GMP Compliance?
Organizations governed by Part 11 are obligated to validate any computerized system used in GMP compliance, with a focus on data integrity and security.
Validating your CMMS means ensuring that the software is correctly installed on a secure server, with backup and redundancy options in place. Access to data needs to be carefully managed, and the software needs to be thoroughly tested to ensure that its core functionality (like data storage and retrieval, reporting, and alerts) works correctly under real-world conditions.
Beyond software validation, 21 CFR Part 11 requires organizations to create audit trails for all compliance documentation so that inspectors can quickly view when, where, and how GMP data is logged. Organizations must implement rigorous access controls to protect data from tampering. The regulations also require electronic signatures to be unique, traceable, and clearly tied to an individual.
What Is EU GMP Annex 11?
Annex 11 is part of the EU’s Eudralex regulations, which govern medicinal products across the territory. Annex 11 specifically addresses how to manage the computerized systems used to document GMP compliance. The guidelines unite standards used across the EU.
The purpose of Annex 11 is broadly similar to Part 11’s goals: ensuring that computerized systems, like CMMS, perform consistently and correctly, delivering accurate and secure records with traceable audit trails.
What Are Annex 11’s Guidelines for the Use of CMMS in GMP Compliance?
Annex 11 uses a risk-based approach to GMP compliance. Like Part 11, Annex 11
requires audit trails and access controls. However, Annex 11 also requires
organizations to independently assess and mitigate the potential risks in their
electronic recordkeeping systems.
This means users must look closely at their whole documentation system, including hardware and software, personnel, and standard operating procedures. They must then implement controls to ensure that the whole system delivers accurate, secure records and that it helps drive the production of high-quality, safe, and effective products.
What Are the Key Differences Between the FDA and EU Guidelines?
Annex 11 and Part 11 share many similarities. Both have the same goal: ensuring recordkeeping accuracy that can easily be verified by outside inspectors. In practice, however, there are some key differences, especially in terms of scope and risk assessment.
These differences include:
- Part 11 is legally binding, while Annex 11 is a flexible set of guidelines.
- Part 11 is focused on electronic records and e-signatures, while Annex 11 covers the broader computerized system.
- Part 11 does not explicitly ask users to implement a risk assessment, while Annex 11 does.
- Part 11 requires audit trails for all electronic records, while Annex 11 requires audit trails for the most critical data sets.
What Are the Challenges in Regulatory Compliance?
Compliance is an ongoing process, not a one-and-done task. Organizations need to frequently revalidate their software and assess their documentation workflows to ensure they maintain compliance.
Maintenance crews need routine training and education based on any changes to regulations. For global organizations, too, juggling both the EU and U.S. guidelines can be confusing. Fortunately, the right technology and partners can help.
Overcoming Part 11 and Annex 11 Regulatory Challenges With eMaint CMMS
Working with a validated CMMS makes GMP compliance much easier, whether you’re subject to Part 11, Annex 11, or both.
eMaint CMMS uses built-in dashboards and audit trails, so your compliance data is always available. Intuitive role-based access controls allow administrators to restrict access to sensitive data, and unique logins ensure that electronic signatures are traceable and verifiable. Our team of experts will also help you validate (or revalidate) your software.
eMaint work order functionality drives standardized maintenance workflows, so your preventive maintenance and calibration tasks are performed correctly, every time. eMaint also offers training programs for your staff, so everyone is on the same page, and you can be confident that you’re delivering safe, pure, and effective products to your customers.