Recently, Inductive Automation released their “21 CFR Part 11 and Pharmaceutical Best Practices with Ignition” document. If your company is covered by 21 CFR Part 11, then you are probably already aware of the compliance requirements. However, there is still value in knowing about the 21 CFR 11 regulation, and the potential benefits of adopting some of the requirements as best practices for your organization.

What is 21 CFR 11?

21 CFR Part 11 is a regulation issued by the United States Food and Drug Administration (FDA). It establishes requirements for electronic records and electronic signatures used in the manufacturing, testing, and distributing of pharmaceutical and medical devices. This regulation ensures that electronic records and signatures are trustworthy, reliable, and secure. It applies to all pharmaceutical and medical device manufacturers operating in the United States. In short, 21 CFR 11 sets the standards for electronic record-keeping and signature processes in these industries to ensure the safety and efficacy of the products they produce.

How Does Ignition Support 21 CFR Part 11 Compliance?

To be in compliance with 21 CFR 11, manufacturers must implement an Electronic Records Management System (ERMS). The ERMS must be able to store, manage, and retrieve electronic records securely. The ERMS should also include audit trails, electronic signatures, and a time-stamping mechanism to ensure the integrity and security of the data.

Inductive Automation’s Ignition provides a comprehensive solution for electronic records management which meets 21 CFR Part 11 requirements. Ignition includes built-in audit trails, electronic signatures using the Perspective Module, and secure data storage, ensuring the integrity and security of electronic records. Ignition also provides a robust reporting system allowing for easily creating audit reports and compliance documentation.

Additionally, Ignition's drag-and-drop interface allows for easy customization, which can help manufacturers tailor their compliance system to their specific needs. Overall, Ignition can help manufacturers achieve and maintain 21 CFR 11 compliance while improving operational efficiency and reducing costs.

Ignition is easy to integrate with databases, ensuring all of the data you need for 21 CFR compliance is stored securely, and indefinitely. This means you can easily use Ignition as a single software platform to manage the Electronic Records Management System (ERMS) requirements of 21 CFR Part 11.

How 21 CFR Part 11 Best Practices Can Benefit All Industries

To meet 21 CFR 11 requirements, companies must focus on five major tasks to implement the processes, procedures, technology, and training required for compliance:

1. Conduct a Risk Assessment: Before implementing 21 CFR 11, assess the risks associated with the manufacturing processes. The risk assessment should identify all potential areas of risk, including cybersecurity threats, data breaches, and data loss.

2. Implement an Electronic Records Management System (ERMS): The ERMS is the backbone of the 21 CFR Part 11 compliance system. The ERMS must be able to store, manage, and retrieve electronic records securely. The system should also include audit trails, electronic signatures, and a time-stamping mechanism to ensure the integrity and security of the data.

3. Develop and Enforce Policies and Procedures: Develop and enforce policies and procedures to ensure that all personnel are aware of their responsibilities in maintaining compliance with 21 CFR 11. The policies should include rules for creating, modifying, and deleting electronic records, as well as guidelines for electronic signatures.

4. Provide Training and Education: All personnel who will be using the electronic records management system must receive training and education on 21 CFR 11 compliance requirements. This training should cover the importance of electronic records management, the responsibilities of personnel, and the consequences of noncompliance.

5. Conduct Regular Audits and Assessments: Conduct regular audits and assessments to ensure that the manufacturing facility remains compliant with 21 CFR Part 11. These assessments should include a review of policies and procedures, the ERMS, and personnel training records. The audits should identify any areas of noncompliance and recommend corrective action.

While 21 CFR 11 is geared towards medical and pharmaceutical manufacturing, here’s how these concepts can apply to manufacturing in any industry.

In today's digital age, electronic records management has become essential for all industries. The manufacturing industry is no exception. With increasing competition and regulatory requirements, manufacturers must ensure the safety and quality of their products. By implementing 21 CFR Part 11 compliance requirements, manufacturers can achieve this goal. The following is

First and foremost, most (if not all) manufacturers should conduct a risk assessment. Manufacturers must understand the obstacles they can expect to face, how to manage those obstacles, and how to overcome any issues which could derail production efforts. A risk assessment applies to project implementations as a whole—not just risks with the process, security concerns, data integrity, and backup/recovery plans. A key part of this risk assessment is to determine how to best mitigate the risks which are discovered. For example, if cybersecurity threats are identified as a risk, manufacturers can implement data encryption and secure data storage measures to protect their electronic records.

Even if your industry isn’t related to medical or pharmaceutical manufacturing, you still need an ERMS system. All of your data, business processes, and information is or will become digitized as you rely more on technology to run your business. You will need a tool to manage and access the data and information you are collecting, so you can make better decisions about improving your operation in real-time. The ERMS must be able to store, manage, and retrieve electronic records securely. The system should include audit trails, electronic signatures, and a time-stamping mechanism to ensure the integrity and security of the data. Ignition is an excellent tool for this.

Developing and enforcing policies and procedures are also critical to achieving manufacturing excellence—regardless of your vertical. Just as a craftsperson needs the right tools on hand for a project, they would also insure that the tools are in good working order. As a manufacturer, you must approach your technological tools with the same mindset. Having the right tools and not using them effectively can actually be more harmful than not having the right tools in the first place. Manufacturers must have clear guidelines for creating, modifying, and deleting electronic records, as well as guidelines for electronic signatures. These policies and procedures must be communicated to all personnel and enforced consistently.

Personnel training and education is also crucial across industries. To use the tools at your disposal effectively, your team needs to know how to use them. Train your team on how to use the available technology effectively. All personnel who will be using your ERMS must receive training and education on 21 CFR Part 11 compliance requirements. This training should cover the importance of electronic records management, the responsibilities of personnel, and the consequences of noncompliance.

Finally, manufacturers must conduct regular audits and assessments to ensure ongoing compliance. It isn’t enough to trust that your systems are communicating correctly and your people are using the tools effectively. It is important to have an audit process in place to make sure everything is running like a well oiled machine. Audits and assessments should review policies and procedures, the ERMS, and personnel training records. The audits should identify any areas of noncompliance and recommend corrective action.

Wrapping Up

Implementing 21 CFR 11 compliance requirements is critical for ensuring the safety and quality of products in manufacturing. By following the tasks we have outlined in this post, manufacturing companies can achieve compliance and maintain it over time. With increased competition and regulatory requirements, manufacturers that implement these requirements can set themselves apart from the competition and ensure the trust of their customers.

Compliance with 21 CFR Part 11 requirements can also help manufacturing companies reduce costs and increase efficiency. By implementing an ERMS, manufacturers can streamline their record-keeping processes and reduce the amount of time and resources required to manage their electronic records. This can lead to increased efficiency and cost savings.

Manufacturers can improve their reputation and credibility by implementing 21 CFR 11 compliance. In today's market, consumers are increasingly concerned about the safety and quality of the products they use. By implementing compliance requirements, manufacturers can demonstrate their commitment to product safety and quality, and gain the trust of their customers.

In conclusion, implementing 21 CFR Part 11 compliance requirements is essential for manufacturers to ensure the safety and quality of their products, increase efficiency, and improve their reputation and credibility. By conducting a risk assessment, implementing an ERMS, developing and enforcing policies and procedures, providing training and education, and conducting regular audits and assessments, manufacturers can achieve compliance and maintain it over time. In doing so, they can set themselves apart from the competition, and gain the trust and loyalty of their customers.