Frustrated by vague 21 CFR Part 11 rules for your food or pharma company?
Well, Infisign addresses each one, with clarity and, most importantly, peace of mind. But help you out further, here’s our 21 CFR Part 11 Compliance Checklist.
This article serves as one simple solution, giving you clear steps for better compliance.
What is 21 CFR Part 11 Compliance?
21 CFR Part 11 is a regulation from the U.S. Food and Drug Administration (FDA). This rule clarifies how businesses can utilize digital records. It also clarifies how they can use digital signatures in place of paper-based ones.
This regulation makes sure that digital information is trustworthy. It also makes sure it is sound for activities governed by the FDA.
The rule establishes specific conditions. These conditions relate to data protection. They also relate to audit trails, which track changes. User entry is another area covered. Adherence means following these directions to uphold the soundness of electronic data.
Who Needs to Pay Attention to 21 CFR Part 11 Compliance?
For businesses, 21 CFR Part 11 is particularly relevant to those operating in FDA-regulated industries. This primarily includes:
- Pharmaceutical companies: These are firms active in creating new drugs. They also manufacture, test, and distribute them.
- Medical device manufacturers: These are businesses that conceptualize, create, and market medical gear and tools.
- Biotechnology companies: These are businesses occupied with study. They also handle the development and making of biological items.
- Food and beverage companies: This applies particularly to those keeping digital records. These records are for safety and quality management, like HACCP plans.
- Cosmetic manufacturers: These are businesses that make and supply cosmetic items.
- Clinical Study Groups (CSGs) and Contract Making Groups (CMGs): These are enterprises that give study or making assistance to the industries mentioned earlier.
- Clinical testing centers: These are places that perform examinations concerning human health and illness.
21 CFR Part 11 Checklist to Crosscheck Your Compliance
21 CFR Part 11 Checklist: How Does Infisign Take Care It?
Let's demystify some of these crucial compliance areas and see how Infisign provides robust solutions.
1. Using Secure System Validation to Create Trust
Imagine constructing a high-performance vehicle. You wouldn't just hope it works; you'd meticulously test every component to guarantee safety and reliability.
System validation in the digital realm is precisely that – it's the critical process of proving that an electronic system performs accurately, reliably, and consistently, just as it's designed to.
This isn't just a checkbox; it's the bedrock of trust in your digital operations.
- Performance You Can Count On: Infisign confirms that its system has been checked. This is to make sure it consistently delivers accurate and dependable performance. This means you can trust the results you get.
- Clear Proof: Wondering about the proof? Infisign states that written proof of these validation checks and their outcomes is available. This gives you a clear picture of its careful work.
- Steady Through Changes: Systems change over time. That's why Infisign has set methods for both system upkeep and managing any changes (change control). This helps make sure that compliance isn't a one-off thing but a continuing commitment.
2. Complete Audit Trails for System Trustworthiness
Have you ever needed to retrace your steps? Or understand the "who, what, when, and why" of something done in your system? In regulated areas, this isn't just helpful. It's a must.
Secure, computer-generated, time-stamped audit trails are the way to go. They act like a permanent diary for your system.
- Automatic & Secure Records: Infisign's system is built to create these key audit trails automatically. This makes sure they are secure. It also makes sure they capture a time-stamped record of what happened.
- Ready for the Long Term: Rules often require that records to be kept for a long time. Infisign makes sure its audit trails are stored for the period required by the current regulations.
- Open for Review: Transparency is important. The audit trails from Infisign can be independently looked over and studied. This supports internal checks and outside inspections.
3. Dependable Electronic Signatures for Reliable Records
How do you match the legal weight and meaning of a handwritten signature? 21 CFR Part 11 sets out strict standards for this.
It’s about making sure an electronic signature is uniquely tied to one person. It also needs to clearly show their approval or action.
- Uniquely Yours: With Infisign, electronic signatures are unique to each person. This removes any question about who signed.
- Clear Context is Important: An Infisign electronic signature isn't just a mark. It includes the signer's printed name, the exact date and time of signing, and, importantly, the reason for the signature. This gives the full picture.
- Building Accountability: To highlight their importance, Infisign supports a policy. This policy holds people responsible for actions taken using their electronic signatures.
4. Careful Access Control and User Authentication
Your data is extremely valuable. Controlling who can get into your system and what they are allowed to do there is a non-negotiable part of security and compliance.
Think of it as a well-built digital fortress with smart guards.
- Authorized People Only: Infisign makes sure that system access is strictly limited. Only people who are authorized can use it.
- Permissions That Fit the Job: Not everyone needs access to everything. Infisign uses Attribute-Based Access Control (ABAC) and Role-Based Access Control (RBAC). These let you give permissions based on a person's specific job duties.
- Managed Access, Always: There are clear methods for the whole user access journey. This includes from giving initial access to changing permissions or removing access when it's necessary.
- Strong Credentials: User IDs and passwords are like the keys to your digital world. They are managed securely within the Infisign system.
5. Keeping Your Information or Maintaining Data Integrity
Once your data is in the system, how do you make sure it stays accurate? How do you make sure it's not changed by unauthorized people and that you can get to it when you need it? This is what record integrity is all about.
- Shielded from Tampering: Infisign takes steps to protect records from any unauthorized access or changes. This keeps them in their original state.
- A Safety Net for Your Data: What if something unexpected happens? Infisign has a backup and recovery method. It's designed to protect your records. So, you can get them back even if problems arise.
- There When You Need It: Records aren't much good if you can't find them. Infisign makes sure that records can be easily found throughout their entire required storage time.
6. Capable Teams and Crystal-Clear Documentation of Processes and Access
Advanced technology is powerful. But truly effective compliance also depends on people who are well-informed. It also relies on documents that are easy to get and understand.
- Knowledgeable Users: Infisign confirms that staff have been trained. They know how to use the electronic systems. They also understand the relevant compliance needs they have to meet.
- Tracked Training: To make sure skills stay current, training records are carefully kept. They are also regularly updated.
- Guidance Readily Available: Clear documents about how the system works, how it's maintained, and its safety measures are available. This gives a valuable point of reference for users and auditors.
Infisign - Your AI-Powered Ally for 21 CFR Part 11 Compliance
Is managing 21 CFR Part 11 a constant source of audit stress and complicated paperwork for you?
Relying on manual ways or generic tools for this key FDA regulation can leave your electronic records and signatures at risk.
This isn't just inefficient; it's a direct compliance danger. That's why our Infisign is built to support Part 11 compliance. Moreover, it also comes with automate user provisioning, audit trails, and PAM that makes it easy to avoid compliance fines.
Imagine audits without the stress and compliance made easy!
Book a free demo to see Infisign in action.
FAQs for 21 CFR Part 11 Compliance
What is the meaning of 21 CFR part 211?
21 CFR Part 211 outlines the Current Good Manufacturing Practice (CGMP) for finished drug products. These regulations are set by the U.S. Food and Drug Administration (FDA). Their main purpose is to make sure that drug products are consistently produced and controlled according to quality standards.
What is 21 CFR full form?
21 CFR stands for Title 21 of the Code of Federal Regulations. This title contains all regulations put out by the U.S. Food and Drug Administration. It covers a wide variety of products, like food, drugs, cosmetics, and medical devices.
What are the three main areas of 21 CFR Part 11?
The three main areas of 21 CFR Part 11 are about electronic records, electronic signatures, and audit trails. Electronic records must be accurate, secure, and findable throughout the time they are kept. Electronic signatures must be unique to a person, verifiable, and legally sound. Audit trails must securely track all creation, changes, and deletion of data.
